Kerri Wachter

Women with multiple sclerosis can be reassured that should they choose to become pregnant, they are generally not at any greater risk of adverse pregnancy or birth outcomes than are similar women without the disease, according to a retrospective cohort study.

The findings should have important clinical implications for this group of patients, because about three-quarters of people with MS are women and the clinical onset of the disease most often occurs in early adulthood, just when many are considering starting a family, Mia L. van der Kop and her coauthors wrote online June 27 in Annals of Neurology.

Studies have shown that one-fifth to one-third of women with MS bear children after disease onset.

Ms. van der Kop and her coinvestigators at the University of British Columbia, Vancouver, linked clinical data from the British Columbia (BC) MS clinics’ database with outcomes data from the BC Perinatal Database Registry (BCPDR) to examine whether maternal MS was associated with adverse neonatal and delivery outcomes and to determine what factors, if any, were associated with risk (Ann. Neurol. 2011 June 27 [doi: 10.1002/ana.22483]).

Since the BCPDR established full provincial coverage in 2000, it has captured more than 99% of births in BC and has gathered information on a wide range of outcomes and potentially confounding variables. The BC MS Clinics’ database is estimated to capture 80% of the MS population in BC.

The investigators measured disability via the Expanded Disability Status Scale (EDSS) score assigned closest to the time of delivery. MS mothers were classified as having a normal neurologic examination score (EDSS = 0), mild disability (EDSS = 1-3), or moderate to severe disability (EDSS at least 3.5).

With the use of a unique personal health number, all female patients who were registered at one of the four MS clinics in BC from 1980 through 2008 were linked at an individual level to births occurring in BC between April 1998 and March 2009. Patients’ names and dates of birth were used to confirm the accuracy of linkage.

Of 7,056 female patients in the BCMS database, the investigators found matches in the BCPDR for 550 women (762 births). These births were compared with 3,048 births from a random sample of women in the general population who were frequency-matched for age, local health authority, and delivery year.

Births were included in the MS group if the mother had laboratory-supported or clinically definite MS (Poser or McDonald criteria) diagnosed by an MS specialist neurologist. Births to mothers whose disease onset occurred after delivery were excluded. Births to individuals with an ICD-9 or -10 code for MS in the BCPDR were excluded from the comparison group. After exclusions, the data set contained 432 births to 321 women with MS and 2,975 births to 2,958 women without MS.

A greater proportion of births in the MS group were to women who were nulliparous, primigravid, hypertensive, or had smoked during pregnancy. A greater proportion of births in the comparison group were to mothers with diabetes during pregnancy and a history of multiple therapeutic abortions. All other baseline characteristics were similar.

Maternal MS was not associated with assisted vaginal delivery (odds ratio, 0.78) or cesarean section (OR, 0.94). The proportion of elective cesarean sections was similar in both the MS and comparison groups (18.6% vs. 16.1%, respectively), and the indication for cesarean delivery did not differ between groups. Delivery outcomes were not associated with either an older age at MS onset or longer disease duration.

The degree of disability in MS mothers was not significantly associated with higher odds of a cesarean section or an assisted vaginal delivery, compared with women who had a normal neurologic examination.

A very small difference in mean birth weight between babies in the two groups was neither clinically nor statistically significant. Gestational age did not differ according to MS clinical factors.

Data on maternal body mass index were missing for 31% of births, so a regression model was developed that excluded BMI. In this model, diabetic status during pregnancy had an interactive effect among participants with diabetes during pregnancy. The mean birth weight of babies born to mothers with MS was 232 g greater than that of babies in the comparison group. Diabetes was not a significant factor, once BMI was taken into account. Regardless of BMI, there were no significant differences in birth weight according to MS clinical factors.

"However, MS mothers were more often overweight or obese. Because high BMI is associated with adverse pregnancy and birth outcomes, women with MS [should be encouraged] to optimize their weight when planning a pregnancy. This also highlights the importance of considering BMI in future investigations of pregnancy-related outcomes," the researchers wrote.

Data on labor duration were available for 312 (72%) births to women with MS and 2,191 (74%) births in the comparison group. Because parity is strongly associated with labor duration, the investigators restricted their analyses to nulliparous women. There was no significant difference in the median duration of the second stage of labor between women with MS and those in the comparison group.

Duration of the second stage of labor was not associated with age at MS onset. The median duration of the second stage of labor increased with disease duration – from 1.08 hours for those with a disease duration of less than 5 years to 1.51 hours for those with a disease duration of at least 10 years. The second stage of labor lasted longer for women with mild (1.38 hours) or moderate/severe impairment (1.38 hours), compared with women with a normal neurologic exam (0.90 hours), but the differences were not statistically significant.

This study was supported by the Canadian Institutes of Health Research. All of the authors reported having significant ties to disease advocacy- or government-based groups, research groups, or pharmaceutical companies.

Women with multiple sclerosis can be reassured that should they choose to become pregnant, they are generally not at any greater risk of adverse pregnancy or birth outcomes than are similar women without the disease, according to a retrospective cohort study.

The findings should have important clinical implications for this group of patients, because about three-quarters of people with MS are women and the clinical onset of the disease most often occurs in early adulthood, just when many are considering starting a family, Mia L. van der Kop and her coauthors wrote online June 27 in Annals of Neurology.

Studies have shown that one-fifth to one-third of women with MS bear children after disease onset.

Ms. van der Kop and her coinvestigators at the University of British Columbia, Vancouver, linked clinical data from the British Columbia (BC) MS clinics’ database with outcomes data from the BC Perinatal Database Registry (BCPDR) to examine whether maternal MS was associated with adverse neonatal and delivery outcomes and to determine what factors, if any, were associated with risk (Ann. Neurol. 2011 June 27 [doi: 10.1002/ana.22483]).

Since the BCPDR established full provincial coverage in 2000, it has captured more than 99% of births in BC and has gathered information on a wide range of outcomes and potentially confounding variables. The BC MS Clinics’ database is estimated to capture 80% of the MS population in BC.

The investigators measured disability via the Expanded Disability Status Scale (EDSS) score assigned closest to the time of delivery. MS mothers were classified as having a normal neurologic examination score (EDSS = 0), mild disability (EDSS = 1-3), or moderate to severe disability (EDSS at least 3.5).

With the use of a unique personal health number, all female patients who were registered at one of the four MS clinics in BC from 1980 through 2008 were linked at an individual level to births occurring in BC between April 1998 and March 2009. Patients’ names and dates of birth were used to confirm the accuracy of linkage.

Of 7,056 female patients in the BCMS database, the investigators found matches in the BCPDR for 550 women (762 births). These births were compared with 3,048 births from a random sample of women in the general population who were frequency-matched for age, local health authority, and delivery year.

Births were included in the MS group if the mother had laboratory-supported or clinically definite MS (Poser or McDonald criteria) diagnosed by an MS specialist neurologist. Births to mothers whose disease onset occurred after delivery were excluded. Births to individuals with an ICD-9 or -10 code for MS in the BCPDR were excluded from the comparison group. After exclusions, the data set contained 432 births to 321 women with MS and 2,975 births to 2,958 women without MS.

A greater proportion of births in the MS group were to women who were nulliparous, primigravid, hypertensive, or had smoked during pregnancy. A greater proportion of births in the comparison group were to mothers with diabetes during pregnancy and a history of multiple therapeutic abortions. All other baseline characteristics were similar.

Maternal MS was not associated with assisted vaginal delivery (odds ratio, 0.78) or cesarean section (OR, 0.94). The proportion of elective cesarean sections was similar in both the MS and comparison groups (18.6% vs. 16.1%, respectively), and the indication for cesarean delivery did not differ between groups. Delivery outcomes were not associated with either an older age at MS onset or longer disease duration.

The degree of disability in MS mothers was not significantly associated with higher odds of a cesarean section or an assisted vaginal delivery, compared with women who had a normal neurologic examination.

A very small difference in mean birth weight between babies in the two groups was neither clinically nor statistically significant. Gestational age did not differ according to MS clinical factors.

Data on maternal body mass index were missing for 31% of births, so a regression model was developed that excluded BMI. In this model, diabetic status during pregnancy had an interactive effect among participants with diabetes during pregnancy. The mean birth weight of babies born to mothers with MS was 232 g greater than that of babies in the comparison group. Diabetes was not a significant factor, once BMI was taken into account. Regardless of BMI, there were no significant differences in birth weight according to MS clinical factors.

"However, MS mothers were more often overweight or obese. Because high BMI is associated with adverse pregnancy and birth outcomes, women with MS [should be encouraged] to optimize their weight when planning a pregnancy. This also highlights the importance of considering BMI in future investigations of pregnancy-related outcomes," the researchers wrote.

Data on labor duration were available for 312 (72%) births to women with MS and 2,191 (74%) births in the comparison group. Because parity is strongly associated with labor duration, the investigators restricted their analyses to nulliparous women. There was no significant difference in the median duration of the second stage of labor between women with MS and those in the comparison group.

Duration of the second stage of labor was not associated with age at MS onset. The median duration of the second stage of labor increased with disease duration – from 1.08 hours for those with a disease duration of less than 5 years to 1.51 hours for those with a disease duration of at least 10 years. The second stage of labor lasted longer for women with mild (1.38 hours) or moderate/severe impairment (1.38 hours), compared with women with a normal neurologic exam (0.90 hours), but the differences were not statistically significant.

This study was supported by the Canadian Institutes of Health Research. All of the authors reported having significant ties to disease advocacy- or government-based groups, research groups, or pharmaceutical companies.

Women with multiple sclerosis can be reassured that should they choose to become pregnant, they are generally not at any greater risk of adverse pregnancy or birth outcomes than are similar women without the disease, according to a retrospective cohort study.

The findings should have important clinical implications for this group of patients, because about three-quarters of people with MS are women and the clinical onset of the disease most often occurs in early adulthood, just when many are considering starting a family, Mia L. van der Kop and her coauthors wrote online June 27 in Annals of Neurology.

Studies have shown that one-fifth to one-third of women with MS bear children after disease onset.

Ms. van der Kop and her coinvestigators at the University of British Columbia, Vancouver, linked clinical data from the British Columbia (BC) MS clinics’ database with outcomes data from the BC Perinatal Database Registry (BCPDR) to examine whether maternal MS was associated with adverse neonatal and delivery outcomes and to determine what factors, if any, were associated with risk (Ann. Neurol. 2011 June 27 [doi: 10.1002/ana.22483]).

Since the BCPDR established full provincial coverage in 2000, it has captured more than 99% of births in BC and has gathered information on a wide range of outcomes and potentially confounding variables. The BC MS Clinics’ database is estimated to capture 80% of the MS population in BC.

The investigators measured disability via the Expanded Disability Status Scale (EDSS) score assigned closest to the time of delivery. MS mothers were classified as having a normal neurologic examination score (EDSS = 0), mild disability (EDSS = 1-3), or moderate to severe disability (EDSS at least 3.5).

With the use of a unique personal health number, all female patients who were registered at one of the four MS clinics in BC from 1980 through 2008 were linked at an individual level to births occurring in BC between April 1998 and March 2009. Patients’ names and dates of birth were used to confirm the accuracy of linkage.

Of 7,056 female patients in the BCMS database, the investigators found matches in the BCPDR for 550 women (762 births). These births were compared with 3,048 births from a random sample of women in the general population who were frequency-matched for age, local health authority, and delivery year.

Births were included in the MS group if the mother had laboratory-supported or clinically definite MS (Poser or McDonald criteria) diagnosed by an MS specialist neurologist. Births to mothers whose disease onset occurred after delivery were excluded. Births to individuals with an ICD-9 or -10 code for MS in the BCPDR were excluded from the comparison group. After exclusions, the data set contained 432 births to 321 women with MS and 2,975 births to 2,958 women without MS.

A greater proportion of births in the MS group were to women who were nulliparous, primigravid, hypertensive, or had smoked during pregnancy. A greater proportion of births in the comparison group were to mothers with diabetes during pregnancy and a history of multiple therapeutic abortions. All other baseline characteristics were similar.

Maternal MS was not associated with assisted vaginal delivery (odds ratio, 0.78) or cesarean section (OR, 0.94). The proportion of elective cesarean sections was similar in both the MS and comparison groups (18.6% vs. 16.1%, respectively), and the indication for cesarean delivery did not differ between groups. Delivery outcomes were not associated with either an older age at MS onset or longer disease duration.

The degree of disability in MS mothers was not significantly associated with higher odds of a cesarean section or an assisted vaginal delivery, compared with women who had a normal neurologic examination.

A very small difference in mean birth weight between babies in the two groups was neither clinically nor statistically significant. Gestational age did not differ according to MS clinical factors.

Data on maternal body mass index were missing for 31% of births, so a regression model was developed that excluded BMI. In this model, diabetic status during pregnancy had an interactive effect among participants with diabetes during pregnancy. The mean birth weight of babies born to mothers with MS was 232 g greater than that of babies in the comparison group. Diabetes was not a significant factor, once BMI was taken into account. Regardless of BMI, there were no significant differences in birth weight according to MS clinical factors.

"However, MS mothers were more often overweight or obese. Because high BMI is associated with adverse pregnancy and birth outcomes, women with MS [should be encouraged] to optimize their weight when planning a pregnancy. This also highlights the importance of considering BMI in future investigations of pregnancy-related outcomes," the researchers wrote.

Data on labor duration were available for 312 (72%) births to women with MS and 2,191 (74%) births in the comparison group. Because parity is strongly associated with labor duration, the investigators restricted their analyses to nulliparous women. There was no significant difference in the median duration of the second stage of labor between women with MS and those in the comparison group.

Duration of the second stage of labor was not associated with age at MS onset. The median duration of the second stage of labor increased with disease duration – from 1.08 hours for those with a disease duration of less than 5 years to 1.51 hours for those with a disease duration of at least 10 years. The second stage of labor lasted longer for women with mild (1.38 hours) or moderate/severe impairment (1.38 hours), compared with women with a normal neurologic exam (0.90 hours), but the differences were not statistically significant.

This study was supported by the Canadian Institutes of Health Research. All of the authors reported having significant ties to disease advocacy- or government-based groups, research groups, or pharmaceutical companies.

Women with multiple sclerosis can be reassured that should they choose to become pregnant, they are generally not at any greater risk of adverse pregnancy or birth outcomes than are similar women without the disease, according to a retrospective cohort study.

The findings should have important clinical implications for this group of patients, because about three-quarters of people with MS are women and the clinical onset of the disease most often occurs in early adulthood, just when many are considering starting a family, Mia L. van der Kop and her coauthors wrote online June 27 in Annals of Neurology.

Studies have shown that one-fifth to one-third of women with MS bear children after disease onset.

Ms. van der Kop and her coinvestigators at the University of British Columbia, Vancouver, linked clinical data from the British Columbia (BC) MS clinics’ database with outcomes data from the BC Perinatal Database Registry (BCPDR) to examine whether maternal MS was associated with adverse neonatal and delivery outcomes and to determine what factors, if any, were associated with risk (Ann. Neurol. 2011 June 27 [doi: 10.1002/ana.22483]).

Since the BCPDR established full provincial coverage in 2000, it has captured more than 99% of births in BC and has gathered information on a wide range of outcomes and potentially confounding variables. The BC MS Clinics’ database is estimated to capture 80% of the MS population in BC.

The investigators measured disability via the Expanded Disability Status Scale (EDSS) score assigned closest to the time of delivery. MS mothers were classified as having a normal neurologic examination score (EDSS = 0), mild disability (EDSS = 1-3), or moderate to severe disability (EDSS at least 3.5).

With the use of a unique personal health number, all female patients who were registered at one of the four MS clinics in BC from 1980 through 2008 were linked at an individual level to births occurring in BC between April 1998 and March 2009. Patients’ names and dates of birth were used to confirm the accuracy of linkage.

Of 7,056 female patients in the BCMS database, the investigators found matches in the BCPDR for 550 women (762 births). These births were compared with 3,048 births from a random sample of women in the general population who were frequency-matched for age, local health authority, and delivery year.

Births were included in the MS group if the mother had laboratory-supported or clinically definite MS (Poser or McDonald criteria) diagnosed by an MS specialist neurologist. Births to mothers whose disease onset occurred after delivery were excluded. Births to individuals with an ICD-9 or -10 code for MS in the BCPDR were excluded from the comparison group. After exclusions, the data set contained 432 births to 321 women with MS and 2,975 births to 2,958 women without MS.

A greater proportion of births in the MS group were to women who were nulliparous, primigravid, hypertensive, or had smoked during pregnancy. A greater proportion of births in the comparison group were to mothers with diabetes during pregnancy and a history of multiple therapeutic abortions. All other baseline characteristics were similar.

Maternal MS was not associated with assisted vaginal delivery (odds ratio, 0.78) or cesarean section (OR, 0.94). The proportion of elective cesarean sections was similar in both the MS and comparison groups (18.6% vs. 16.1%, respectively), and the indication for cesarean delivery did not differ between groups. Delivery outcomes were not associated with either an older age at MS onset or longer disease duration.

The degree of disability in MS mothers was not significantly associated with higher odds of a cesarean section or an assisted vaginal delivery, compared with women who had a normal neurologic examination.

A very small difference in mean birth weight between babies in the two groups was neither clinically nor statistically significant. Gestational age did not differ according to MS clinical factors.

Data on maternal body mass index were missing for 31% of births, so a regression model was developed that excluded BMI. In this model, diabetic status during pregnancy had an interactive effect among participants with diabetes during pregnancy. The mean birth weight of babies born to mothers with MS was 232 g greater than that of babies in the comparison group. Diabetes was not a significant factor, once BMI was taken into account. Regardless of BMI, there were no significant differences in birth weight according to MS clinical factors.

"However, MS mothers were more often overweight or obese. Because high BMI is associated with adverse pregnancy and birth outcomes, women with MS [should be encouraged] to optimize their weight when planning a pregnancy. This also highlights the importance of considering BMI in future investigations of pregnancy-related outcomes," the researchers wrote.

Data on labor duration were available for 312 (72%) births to women with MS and 2,191 (74%) births in the comparison group. Because parity is strongly associated with labor duration, the investigators restricted their analyses to nulliparous women. There was no significant difference in the median duration of the second stage of labor between women with MS and those in the comparison group.

Duration of the second stage of labor was not associated with age at MS onset. The median duration of the second stage of labor increased with disease duration – from 1.08 hours for those with a disease duration of less than 5 years to 1.51 hours for those with a disease duration of at least 10 years. The second stage of labor lasted longer for women with mild (1.38 hours) or moderate/severe impairment (1.38 hours), compared with women with a normal neurologic exam (0.90 hours), but the differences were not statistically significant.

This study was supported by the Canadian Institutes of Health Research. All of the authors reported having significant ties to disease advocacy- or government-based groups, research groups, or pharmaceutical companies.

Women with multiple sclerosis can be reassured that should they choose to become pregnant, they are generally not at any greater risk of adverse pregnancy or birth outcomes than are similar women without the disease, according to a retrospective cohort study.

The findings should have important clinical implications for this group of patients, because about three-quarters of people with MS are women and the clinical onset of the disease most often occurs in early adulthood, just when many are considering starting a family, Mia L. van der Kop and her coauthors wrote online June 27 in Annals of Neurology.

Studies have shown that one-fifth to one-third of women with MS bear children after disease onset.

Ms. van der Kop and her coinvestigators at the University of British Columbia, Vancouver, linked clinical data from the British Columbia (BC) MS clinics’ database with outcomes data from the BC Perinatal Database Registry (BCPDR) to examine whether maternal MS was associated with adverse neonatal and delivery outcomes and to determine what factors, if any, were associated with risk (Ann. Neurol. 2011 June 27 [doi: 10.1002/ana.22483]).

Since the BCPDR established full provincial coverage in 2000, it has captured more than 99% of births in BC and has gathered information on a wide range of outcomes and potentially confounding variables. The BC MS Clinics’ database is estimated to capture 80% of the MS population in BC.

The investigators measured disability via the Expanded Disability Status Scale (EDSS) score assigned closest to the time of delivery. MS mothers were classified as having a normal neurologic examination score (EDSS = 0), mild disability (EDSS = 1-3), or moderate to severe disability (EDSS at least 3.5).

With the use of a unique personal health number, all female patients who were registered at one of the four MS clinics in BC from 1980 through 2008 were linked at an individual level to births occurring in BC between April 1998 and March 2009. Patients’ names and dates of birth were used to confirm the accuracy of linkage.

Of 7,056 female patients in the BCMS database, the investigators found matches in the BCPDR for 550 women (762 births). These births were compared with 3,048 births from a random sample of women in the general population who were frequency-matched for age, local health authority, and delivery year.

Births were included in the MS group if the mother had laboratory-supported or clinically definite MS (Poser or McDonald criteria) diagnosed by an MS specialist neurologist. Births to mothers whose disease onset occurred after delivery were excluded. Births to individuals with an ICD-9 or -10 code for MS in the BCPDR were excluded from the comparison group. After exclusions, the data set contained 432 births to 321 women with MS and 2,975 births to 2,958 women without MS.

A greater proportion of births in the MS group were to women who were nulliparous, primigravid, hypertensive, or had smoked during pregnancy. A greater proportion of births in the comparison group were to mothers with diabetes during pregnancy and a history of multiple therapeutic abortions. All other baseline characteristics were similar.

Maternal MS was not associated with assisted vaginal delivery (odds ratio, 0.78) or cesarean section (OR, 0.94). The proportion of elective cesarean sections was similar in both the MS and comparison groups (18.6% vs. 16.1%, respectively), and the indication for cesarean delivery did not differ between groups. Delivery outcomes were not associated with either an older age at MS onset or longer disease duration.

The degree of disability in MS mothers was not significantly associated with higher odds of a cesarean section or an assisted vaginal delivery, compared with women who had a normal neurologic examination.

A very small difference in mean birth weight between babies in the two groups was neither clinically nor statistically significant. Gestational age did not differ according to MS clinical factors.

Data on maternal body mass index were missing for 31% of births, so a regression model was developed that excluded BMI. In this model, diabetic status during pregnancy had an interactive effect among participants with diabetes during pregnancy. The mean birth weight of babies born to mothers with MS was 232 g greater than that of babies in the comparison group. Diabetes was not a significant factor, once BMI was taken into account. Regardless of BMI, there were no significant differences in birth weight according to MS clinical factors.

"However, MS mothers were more often overweight or obese. Because high BMI is associated with adverse pregnancy and birth outcomes, women with MS [should be encouraged] to optimize their weight when planning a pregnancy. This also highlights the importance of considering BMI in future investigations of pregnancy-related outcomes," the researchers wrote.

Data on labor duration were available for 312 (72%) births to women with MS and 2,191 (74%) births in the comparison group. Because parity is strongly associated with labor duration, the investigators restricted their analyses to nulliparous women. There was no significant difference in the median duration of the second stage of labor between women with MS and those in the comparison group.

Duration of the second stage of labor was not associated with age at MS onset. The median duration of the second stage of labor increased with disease duration – from 1.08 hours for those with a disease duration of less than 5 years to 1.51 hours for those with a disease duration of at least 10 years. The second stage of labor lasted longer for women with mild (1.38 hours) or moderate/severe impairment (1.38 hours), compared with women with a normal neurologic exam (0.90 hours), but the differences were not statistically significant.

This study was supported by the Canadian Institutes of Health Research. All of the authors reported having significant ties to disease advocacy- or government-based groups, research groups, or pharmaceutical companies.

Women with multiple sclerosis can be reassured that should they choose to become pregnant, they are generally not at any greater risk of adverse pregnancy or birth outcomes than are similar women without the disease, according to a retrospective cohort study.

The findings should have important clinical implications for this group of patients, because about three-quarters of people with MS are women and the clinical onset of the disease most often occurs in early adulthood, just when many are considering starting a family, Mia L. van der Kop and her coauthors wrote online June 27 in Annals of Neurology.

Studies have shown that one-fifth to one-third of women with MS bear children after disease onset.

Ms. van der Kop and her coinvestigators at the University of British Columbia, Vancouver, linked clinical data from the British Columbia (BC) MS clinics’ database with outcomes data from the BC Perinatal Database Registry (BCPDR) to examine whether maternal MS was associated with adverse neonatal and delivery outcomes and to determine what factors, if any, were associated with risk (Ann. Neurol. 2011 June 27 [doi: 10.1002/ana.22483]).

Since the BCPDR established full provincial coverage in 2000, it has captured more than 99% of births in BC and has gathered information on a wide range of outcomes and potentially confounding variables. The BC MS Clinics’ database is estimated to capture 80% of the MS population in BC.

The investigators measured disability via the Expanded Disability Status Scale (EDSS) score assigned closest to the time of delivery. MS mothers were classified as having a normal neurologic examination score (EDSS = 0), mild disability (EDSS = 1-3), or moderate to severe disability (EDSS at least 3.5).

With the use of a unique personal health number, all female patients who were registered at one of the four MS clinics in BC from 1980 through 2008 were linked at an individual level to births occurring in BC between April 1998 and March 2009. Patients’ names and dates of birth were used to confirm the accuracy of linkage.

Of 7,056 female patients in the BCMS database, the investigators found matches in the BCPDR for 550 women (762 births). These births were compared with 3,048 births from a random sample of women in the general population who were frequency-matched for age, local health authority, and delivery year.

Births were included in the MS group if the mother had laboratory-supported or clinically definite MS (Poser or McDonald criteria) diagnosed by an MS specialist neurologist. Births to mothers whose disease onset occurred after delivery were excluded. Births to individuals with an ICD-9 or -10 code for MS in the BCPDR were excluded from the comparison group. After exclusions, the data set contained 432 births to 321 women with MS and 2,975 births to 2,958 women without MS.

A greater proportion of births in the MS group were to women who were nulliparous, primigravid, hypertensive, or had smoked during pregnancy. A greater proportion of births in the comparison group were to mothers with diabetes during pregnancy and a history of multiple therapeutic abortions. All other baseline characteristics were similar.

Maternal MS was not associated with assisted vaginal delivery (odds ratio, 0.78) or cesarean section (OR, 0.94). The proportion of elective cesarean sections was similar in both the MS and comparison groups (18.6% vs. 16.1%, respectively), and the indication for cesarean delivery did not differ between groups. Delivery outcomes were not associated with either an older age at MS onset or longer disease duration.

The degree of disability in MS mothers was not significantly associated with higher odds of a cesarean section or an assisted vaginal delivery, compared with women who had a normal neurologic examination.

A very small difference in mean birth weight between babies in the two groups was neither clinically nor statistically significant. Gestational age did not differ according to MS clinical factors.

Data on maternal body mass index were missing for 31% of births, so a regression model was developed that excluded BMI. In this model, diabetic status during pregnancy had an interactive effect among participants with diabetes during pregnancy. The mean birth weight of babies born to mothers with MS was 232 g greater than that of babies in the comparison group. Diabetes was not a significant factor, once BMI was taken into account. Regardless of BMI, there were no significant differences in birth weight according to MS clinical factors.

"However, MS mothers were more often overweight or obese. Because high BMI is associated with adverse pregnancy and birth outcomes, women with MS [should be encouraged] to optimize their weight when planning a pregnancy. This also highlights the importance of considering BMI in future investigations of pregnancy-related outcomes," the researchers wrote.

Data on labor duration were available for 312 (72%) births to women with MS and 2,191 (74%) births in the comparison group. Because parity is strongly associated with labor duration, the investigators restricted their analyses to nulliparous women. There was no significant difference in the median duration of the second stage of labor between women with MS and those in the comparison group.

Duration of the second stage of labor was not associated with age at MS onset. The median duration of the second stage of labor increased with disease duration – from 1.08 hours for those with a disease duration of less than 5 years to 1.51 hours for those with a disease duration of at least 10 years. The second stage of labor lasted longer for women with mild (1.38 hours) or moderate/severe impairment (1.38 hours), compared with women with a normal neurologic exam (0.90 hours), but the differences were not statistically significant.

This study was supported by the Canadian Institutes of Health Research. All of the authors reported having significant ties to disease advocacy- or government-based groups, research groups, or pharmaceutical companies.

Women with multiple sclerosis can be reassured that should they choose to become pregnant, they are generally not at any greater risk of adverse pregnancy or birth outcomes than are similar women without the disease, according to a retrospective cohort study.

The findings should have important clinical implications for this group of patients, because about three-quarters of people with MS are women and the clinical onset of the disease most often occurs in early adulthood, just when many are considering starting a family, Mia L. van der Kop and her coauthors wrote online June 27 in Annals of Neurology.

Studies have shown that one-fifth to one-third of women with MS bear children after disease onset.

Ms. van der Kop and her coinvestigators at the University of British Columbia, Vancouver, linked clinical data from the British Columbia (BC) MS clinics’ database with outcomes data from the BC Perinatal Database Registry (BCPDR) to examine whether maternal MS was associated with adverse neonatal and delivery outcomes and to determine what factors, if any, were associated with risk (Ann. Neurol. 2011 June 27 [doi: 10.1002/ana.22483]).

Since the BCPDR established full provincial coverage in 2000, it has captured more than 99% of births in BC and has gathered information on a wide range of outcomes and potentially confounding variables. The BC MS Clinics’ database is estimated to capture 80% of the MS population in BC.

The investigators measured disability via the Expanded Disability Status Scale (EDSS) score assigned closest to the time of delivery. MS mothers were classified as having a normal neurologic examination score (EDSS = 0), mild disability (EDSS = 1-3), or moderate to severe disability (EDSS at least 3.5).

With the use of a unique personal health number, all female patients who were registered at one of the four MS clinics in BC from 1980 through 2008 were linked at an individual level to births occurring in BC between April 1998 and March 2009. Patients’ names and dates of birth were used to confirm the accuracy of linkage.

Of 7,056 female patients in the BCMS database, the investigators found matches in the BCPDR for 550 women (762 births). These births were compared with 3,048 births from a random sample of women in the general population who were frequency-matched for age, local health authority, and delivery year.

Births were included in the MS group if the mother had laboratory-supported or clinically definite MS (Poser or McDonald criteria) diagnosed by an MS specialist neurologist. Births to mothers whose disease onset occurred after delivery were excluded. Births to individuals with an ICD-9 or -10 code for MS in the BCPDR were excluded from the comparison group. After exclusions, the data set contained 432 births to 321 women with MS and 2,975 births to 2,958 women without MS.

A greater proportion of births in the MS group were to women who were nulliparous, primigravid, hypertensive, or had smoked during pregnancy. A greater proportion of births in the comparison group were to mothers with diabetes during pregnancy and a history of multiple therapeutic abortions. All other baseline characteristics were similar.

Maternal MS was not associated with assisted vaginal delivery (odds ratio, 0.78) or cesarean section (OR, 0.94). The proportion of elective cesarean sections was similar in both the MS and comparison groups (18.6% vs. 16.1%, respectively), and the indication for cesarean delivery did not differ between groups. Delivery outcomes were not associated with either an older age at MS onset or longer disease duration.

The degree of disability in MS mothers was not significantly associated with higher odds of a cesarean section or an assisted vaginal delivery, compared with women who had a normal neurologic examination.

A very small difference in mean birth weight between babies in the two groups was neither clinically nor statistically significant. Gestational age did not differ according to MS clinical factors.

Data on maternal body mass index were missing for 31% of births, so a regression model was developed that excluded BMI. In this model, diabetic status during pregnancy had an interactive effect among participants with diabetes during pregnancy. The mean birth weight of babies born to mothers with MS was 232 g greater than that of babies in the comparison group. Diabetes was not a significant factor, once BMI was taken into account. Regardless of BMI, there were no significant differences in birth weight according to MS clinical factors.

"However, MS mothers were more often overweight or obese. Because high BMI is associated with adverse pregnancy and birth outcomes, women with MS [should be encouraged] to optimize their weight when planning a pregnancy. This also highlights the importance of considering BMI in future investigations of pregnancy-related outcomes," the researchers wrote.

Data on labor duration were available for 312 (72%) births to women with MS and 2,191 (74%) births in the comparison group. Because parity is strongly associated with labor duration, the investigators restricted their analyses to nulliparous women. There was no significant difference in the median duration of the second stage of labor between women with MS and those in the comparison group.

Duration of the second stage of labor was not associated with age at MS onset. The median duration of the second stage of labor increased with disease duration – from 1.08 hours for those with a disease duration of less than 5 years to 1.51 hours for those with a disease duration of at least 10 years. The second stage of labor lasted longer for women with mild (1.38 hours) or moderate/severe impairment (1.38 hours), compared with women with a normal neurologic exam (0.90 hours), but the differences were not statistically significant.

This study was supported by the Canadian Institutes of Health Research. All of the authors reported having significant ties to disease advocacy- or government-based groups, research groups, or pharmaceutical companies.

Women with multiple sclerosis can be reassured that should they choose to become pregnant, they are generally not at any greater risk of adverse pregnancy or birth outcomes than are similar women without the disease, according to a retrospective cohort study.

The findings should have important clinical implications for this group of patients, because about three-quarters of people with MS are women and the clinical onset of the disease most often occurs in early adulthood, just when many are considering starting a family, Mia L. van der Kop and her coauthors wrote online June 27 in Annals of Neurology.

Studies have shown that one-fifth to one-third of women with MS bear children after disease onset.

Ms. van der Kop and her coinvestigators at the University of British Columbia, Vancouver, linked clinical data from the British Columbia (BC) MS clinics’ database with outcomes data from the BC Perinatal Database Registry (BCPDR) to examine whether maternal MS was associated with adverse neonatal and delivery outcomes and to determine what factors, if any, were associated with risk (Ann. Neurol. 2011 June 27 [doi: 10.1002/ana.22483]).

Since the BCPDR established full provincial coverage in 2000, it has captured more than 99% of births in BC and has gathered information on a wide range of outcomes and potentially confounding variables. The BC MS Clinics’ database is estimated to capture 80% of the MS population in BC.

The investigators measured disability via the Expanded Disability Status Scale (EDSS) score assigned closest to the time of delivery. MS mothers were classified as having a normal neurologic examination score (EDSS = 0), mild disability (EDSS = 1-3), or moderate to severe disability (EDSS at least 3.5).

With the use of a unique personal health number, all female patients who were registered at one of the four MS clinics in BC from 1980 through 2008 were linked at an individual level to births occurring in BC between April 1998 and March 2009. Patients’ names and dates of birth were used to confirm the accuracy of linkage.

Of 7,056 female patients in the BCMS database, the investigators found matches in the BCPDR for 550 women (762 births). These births were compared with 3,048 births from a random sample of women in the general population who were frequency-matched for age, local health authority, and delivery year.

Births were included in the MS group if the mother had laboratory-supported or clinically definite MS (Poser or McDonald criteria) diagnosed by an MS specialist neurologist. Births to mothers whose disease onset occurred after delivery were excluded. Births to individuals with an ICD-9 or -10 code for MS in the BCPDR were excluded from the comparison group. After exclusions, the data set contained 432 births to 321 women with MS and 2,975 births to 2,958 women without MS.

A greater proportion of births in the MS group were to women who were nulliparous, primigravid, hypertensive, or had smoked during pregnancy. A greater proportion of births in the comparison group were to mothers with diabetes during pregnancy and a history of multiple therapeutic abortions. All other baseline characteristics were similar.

Maternal MS was not associated with assisted vaginal delivery (odds ratio, 0.78) or cesarean section (OR, 0.94). The proportion of elective cesarean sections was similar in both the MS and comparison groups (18.6% vs. 16.1%, respectively), and the indication for cesarean delivery did not differ between groups. Delivery outcomes were not associated with either an older age at MS onset or longer disease duration.

The degree of disability in MS mothers was not significantly associated with higher odds of a cesarean section or an assisted vaginal delivery, compared with women who had a normal neurologic examination.

A very small difference in mean birth weight between babies in the two groups was neither clinically nor statistically significant. Gestational age did not differ according to MS clinical factors.

Data on maternal body mass index were missing for 31% of births, so a regression model was developed that excluded BMI. In this model, diabetic status during pregnancy had an interactive effect among participants with diabetes during pregnancy. The mean birth weight of babies born to mothers with MS was 232 g greater than that of babies in the comparison group. Diabetes was not a significant factor, once BMI was taken into account. Regardless of BMI, there were no significant differences in birth weight according to MS clinical factors.

"However, MS mothers were more often overweight or obese. Because high BMI is associated with adverse pregnancy and birth outcomes, women with MS [should be encouraged] to optimize their weight when planning a pregnancy. This also highlights the importance of considering BMI in future investigations of pregnancy-related outcomes," the researchers wrote.

Data on labor duration were available for 312 (72%) births to women with MS and 2,191 (74%) births in the comparison group. Because parity is strongly associated with labor duration, the investigators restricted their analyses to nulliparous women. There was no significant difference in the median duration of the second stage of labor between women with MS and those in the comparison group.

Duration of the second stage of labor was not associated with age at MS onset. The median duration of the second stage of labor increased with disease duration – from 1.08 hours for those with a disease duration of less than 5 years to 1.51 hours for those with a disease duration of at least 10 years. The second stage of labor lasted longer for women with mild (1.38 hours) or moderate/severe impairment (1.38 hours), compared with women with a normal neurologic exam (0.90 hours), but the differences were not statistically significant.

This study was supported by the Canadian Institutes of Health Research. All of the authors reported having significant ties to disease advocacy- or government-based groups, research groups, or pharmaceutical companies.

Women with multiple sclerosis can be reassured that should they choose to become pregnant, they are generally not at any greater risk of adverse pregnancy or birth outcomes than are similar women without the disease, according to a retrospective cohort study.

The findings should have important clinical implications for this group of patients, because about three-quarters of people with MS are women and the clinical onset of the disease most often occurs in early adulthood, just when many are considering starting a family, Mia L. van der Kop and her coauthors wrote online June 27 in Annals of Neurology.

Studies have shown that one-fifth to one-third of women with MS bear children after disease onset.

Ms. van der Kop and her coinvestigators at the University of British Columbia, Vancouver, linked clinical data from the British Columbia (BC) MS clinics’ database with outcomes data from the BC Perinatal Database Registry (BCPDR) to examine whether maternal MS was associated with adverse neonatal and delivery outcomes and to determine what factors, if any, were associated with risk (Ann. Neurol. 2011 June 27 [doi: 10.1002/ana.22483]).

Since the BCPDR established full provincial coverage in 2000, it has captured more than 99% of births in BC and has gathered information on a wide range of outcomes and potentially confounding variables. The BC MS Clinics’ database is estimated to capture 80% of the MS population in BC.

The investigators measured disability via the Expanded Disability Status Scale (EDSS) score assigned closest to the time of delivery. MS mothers were classified as having a normal neurologic examination score (EDSS = 0), mild disability (EDSS = 1-3), or moderate to severe disability (EDSS at least 3.5).

With the use of a unique personal health number, all female patients who were registered at one of the four MS clinics in BC from 1980 through 2008 were linked at an individual level to births occurring in BC between April 1998 and March 2009. Patients’ names and dates of birth were used to confirm the accuracy of linkage.

Of 7,056 female patients in the BCMS database, the investigators found matches in the BCPDR for 550 women (762 births). These births were compared with 3,048 births from a random sample of women in the general population who were frequency-matched for age, local health authority, and delivery year.

Births were included in the MS group if the mother had laboratory-supported or clinically definite MS (Poser or McDonald criteria) diagnosed by an MS specialist neurologist. Births to mothers whose disease onset occurred after delivery were excluded. Births to individuals with an ICD-9 or -10 code for MS in the BCPDR were excluded from the comparison group. After exclusions, the data set contained 432 births to 321 women with MS and 2,975 births to 2,958 women without MS.

A greater proportion of births in the MS group were to women who were nulliparous, primigravid, hypertensive, or had smoked during pregnancy. A greater proportion of births in the comparison group were to mothers with diabetes during pregnancy and a history of multiple therapeutic abortions. All other baseline characteristics were similar.

Maternal MS was not associated with assisted vaginal delivery (odds ratio, 0.78) or cesarean section (OR, 0.94). The proportion of elective cesarean sections was similar in both the MS and comparison groups (18.6% vs. 16.1%, respectively), and the indication for cesarean delivery did not differ between groups. Delivery outcomes were not associated with either an older age at MS onset or longer disease duration.

The degree of disability in MS mothers was not significantly associated with higher odds of a cesarean section or an assisted vaginal delivery, compared with women who had a normal neurologic examination.

A very small difference in mean birth weight between babies in the two groups was neither clinically nor statistically significant. Gestational age did not differ according to MS clinical factors.

Data on maternal body mass index were missing for 31% of births, so a regression model was developed that excluded BMI. In this model, diabetic status during pregnancy had an interactive effect among participants with diabetes during pregnancy. The mean birth weight of babies born to mothers with MS was 232 g greater than that of babies in the comparison group. Diabetes was not a significant factor, once BMI was taken into account. Regardless of BMI, there were no significant differences in birth weight according to MS clinical factors.

"However, MS mothers were more often overweight or obese. Because high BMI is associated with adverse pregnancy and birth outcomes, women with MS [should be encouraged] to optimize their weight when planning a pregnancy. This also highlights the importance of considering BMI in future investigations of pregnancy-related outcomes," the researchers wrote.

Data on labor duration were available for 312 (72%) births to women with MS and 2,191 (74%) births in the comparison group. Because parity is strongly associated with labor duration, the investigators restricted their analyses to nulliparous women. There was no significant difference in the median duration of the second stage of labor between women with MS and those in the comparison group.

Duration of the second stage of labor was not associated with age at MS onset. The median duration of the second stage of labor increased with disease duration – from 1.08 hours for those with a disease duration of less than 5 years to 1.51 hours for those with a disease duration of at least 10 years. The second stage of labor lasted longer for women with mild (1.38 hours) or moderate/severe impairment (1.38 hours), compared with women with a normal neurologic exam (0.90 hours), but the differences were not statistically significant.

This study was supported by the Canadian Institutes of Health Research. All of the authors reported having significant ties to disease advocacy- or government-based groups, research groups, or pharmaceutical companies.

Preliminary safety data from postmarketing studies confirm that silicone gel–filled breast implants are safe and effective when used as intended, but women should fully understand the risks prior to considering the implants for breast augmentation or reconstruction.

The data come from a report released June 22 by the Food and Drug Administration that updates the clinical and scientific information for silicone implants.

"Our review of this information continues to support the safety and effectiveness of silicone gel–filled implants when used as intended," Dr. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said during a press briefing. "We also want women to fully understand the risks and complications associated with these implants prior to considering them for breast augmentation or reconstruction."

As part of the FDA's November 2006 approval of two silicone gel–filled breast implants (the Allergan Natrelle and the Mentor MemoryGel), each manufacturer was required to conduct postapproval studies to characterize the long-term performance and safety of the devices.

In January 2011, the agency issued a statement about a possible but small association between silicone implants and anaplastic large cell lymphoma (ALCL).

The FDA's new "Update on the Safety of Silicone Gel-Filled Breast Implants" provides a clinical update on the two silicone gel–filled breast implants available in the United States. The updated information includes preliminary data from the postapproval studies, a summary and analysis of adverse events reported to the FDA since approval, and a review and analysis of recent clinical publications about the safety and effectiveness of silicone gel–filled breast implants.

"I do want to emphasize today [that these data are] preliminary and that there are many more years of data collection needed to complete the required 10-year studies," said Dr. Shuren. The report is not intended to provide a comprehensive clinical update about the safety of saline-filled breast implants.

Based on this report, according to the FDA news release, women should know the following:

• Breast implants are not lifetime devices. The longer a woman has silicone gel–filled breast implants, the more likely she is to experience complications. One in five patients who receives implants for breast augmentation will need them removed within 10 years of implantation. For patients who receive implants for breast reconstruction, as many as one in two will require removal 10 years after implantation.

• The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation (additional surgeries), and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection.

• The complications that existed for women who received breast implants at the time of approval are similar to the complications observed today.

• Preliminary data do not indicate that silicone gel–filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer in duration than those conducted thus far.

The FDA will be holding an expert advisory panel in the next few months to discuss how postapproval studies on breast implants can be more effective. For now, the agency is recommending that health care professionals and women who have silicone gel–filled breast implants do the following:

• Follow up. Women should continue to routinely follow up with their health care professionals. This includes getting routine MRIs to detect silent rupture. Dr. Shuren noted that the first MRI should occur at 3 years post implantation and every 2 years after that.

• Be aware. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring, and infection.

• Pay attention to changes. Women should notify their health care professionals if they develop any unusual symptoms. All serious side effects should be reported to the breast implant manufacturer and Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.

• Stay in touch. If a woman has enrolled in a manufacturer-sponsored postapproval study, she should continue to participate. These studies are the best way to collect information about the long-term rates of complications.

The agency also redesigned its website to include comprehensive information on silicone gel–filled and saline-filled breast implants.

For more information, view the "Executive Summary," the "Breast Implants: Consumer Update," and "Things to Consider, Before You Get Breast Implants."

Preliminary safety data from postmarketing studies confirm that silicone gel–filled breast implants are safe and effective when used as intended, but women should fully understand the risks prior to considering the implants for breast augmentation or reconstruction.

The data come from a report released June 22 by the Food and Drug Administration that updates the clinical and scientific information for silicone implants.

"Our review of this information continues to support the safety and effectiveness of silicone gel–filled implants when used as intended," Dr. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said during a press briefing. "We also want women to fully understand the risks and complications associated with these implants prior to considering them for breast augmentation or reconstruction."

As part of the FDA's November 2006 approval of two silicone gel–filled breast implants (the Allergan Natrelle and the Mentor MemoryGel), each manufacturer was required to conduct postapproval studies to characterize the long-term performance and safety of the devices.

In January 2011, the agency issued a statement about a possible but small association between silicone implants and anaplastic large cell lymphoma (ALCL).

The FDA's new "Update on the Safety of Silicone Gel-Filled Breast Implants" provides a clinical update on the two silicone gel–filled breast implants available in the United States. The updated information includes preliminary data from the postapproval studies, a summary and analysis of adverse events reported to the FDA since approval, and a review and analysis of recent clinical publications about the safety and effectiveness of silicone gel–filled breast implants.

"I do want to emphasize today [that these data are] preliminary and that there are many more years of data collection needed to complete the required 10-year studies," said Dr. Shuren. The report is not intended to provide a comprehensive clinical update about the safety of saline-filled breast implants.

Based on this report, according to the FDA news release, women should know the following:

• Breast implants are not lifetime devices. The longer a woman has silicone gel–filled breast implants, the more likely she is to experience complications. One in five patients who receives implants for breast augmentation will need them removed within 10 years of implantation. For patients who receive implants for breast reconstruction, as many as one in two will require removal 10 years after implantation.

• The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation (additional surgeries), and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection.

• The complications that existed for women who received breast implants at the time of approval are similar to the complications observed today.

• Preliminary data do not indicate that silicone gel–filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer in duration than those conducted thus far.

The FDA will be holding an expert advisory panel in the next few months to discuss how postapproval studies on breast implants can be more effective. For now, the agency is recommending that health care professionals and women who have silicone gel–filled breast implants do the following:

• Follow up. Women should continue to routinely follow up with their health care professionals. This includes getting routine MRIs to detect silent rupture. Dr. Shuren noted that the first MRI should occur at 3 years post implantation and every 2 years after that.

• Be aware. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring, and infection.

• Pay attention to changes. Women should notify their health care professionals if they develop any unusual symptoms. All serious side effects should be reported to the breast implant manufacturer and Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.

• Stay in touch. If a woman has enrolled in a manufacturer-sponsored postapproval study, she should continue to participate. These studies are the best way to collect information about the long-term rates of complications.

The agency also redesigned its website to include comprehensive information on silicone gel–filled and saline-filled breast implants.

For more information, view the "Executive Summary," the "Breast Implants: Consumer Update," and "Things to Consider, Before You Get Breast Implants."

Preliminary safety data from postmarketing studies confirm that silicone gel–filled breast implants are safe and effective when used as intended, but women should fully understand the risks prior to considering the implants for breast augmentation or reconstruction.

The data come from a report released June 22 by the Food and Drug Administration that updates the clinical and scientific information for silicone implants.

"Our review of this information continues to support the safety and effectiveness of silicone gel–filled implants when used as intended," Dr. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said during a press briefing. "We also want women to fully understand the risks and complications associated with these implants prior to considering them for breast augmentation or reconstruction."

As part of the FDA's November 2006 approval of two silicone gel–filled breast implants (the Allergan Natrelle and the Mentor MemoryGel), each manufacturer was required to conduct postapproval studies to characterize the long-term performance and safety of the devices.

In January 2011, the agency issued a statement about a possible but small association between silicone implants and anaplastic large cell lymphoma (ALCL).

The FDA's new "Update on the Safety of Silicone Gel-Filled Breast Implants" provides a clinical update on the two silicone gel–filled breast implants available in the United States. The updated information includes preliminary data from the postapproval studies, a summary and analysis of adverse events reported to the FDA since approval, and a review and analysis of recent clinical publications about the safety and effectiveness of silicone gel–filled breast implants.

"I do want to emphasize today [that these data are] preliminary and that there are many more years of data collection needed to complete the required 10-year studies," said Dr. Shuren. The report is not intended to provide a comprehensive clinical update about the safety of saline-filled breast implants.

Based on this report, according to the FDA news release, women should know the following:

• Breast implants are not lifetime devices. The longer a woman has silicone gel–filled breast implants, the more likely she is to experience complications. One in five patients who receives implants for breast augmentation will need them removed within 10 years of implantation. For patients who receive implants for breast reconstruction, as many as one in two will require removal 10 years after implantation.

• The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation (additional surgeries), and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection.

• The complications that existed for women who received breast implants at the time of approval are similar to the complications observed today.

• Preliminary data do not indicate that silicone gel–filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer in duration than those conducted thus far.

The FDA will be holding an expert advisory panel in the next few months to discuss how postapproval studies on breast implants can be more effective. For now, the agency is recommending that health care professionals and women who have silicone gel–filled breast implants do the following:

• Follow up. Women should continue to routinely follow up with their health care professionals. This includes getting routine MRIs to detect silent rupture. Dr. Shuren noted that the first MRI should occur at 3 years post implantation and every 2 years after that.

• Be aware. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring, and infection.

• Pay attention to changes. Women should notify their health care professionals if they develop any unusual symptoms. All serious side effects should be reported to the breast implant manufacturer and Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.

• Stay in touch. If a woman has enrolled in a manufacturer-sponsored postapproval study, she should continue to participate. These studies are the best way to collect information about the long-term rates of complications.

The agency also redesigned its website to include comprehensive information on silicone gel–filled and saline-filled breast implants.

For more information, view the "Executive Summary," the "Breast Implants: Consumer Update," and "Things to Consider, Before You Get Breast Implants."

Preliminary safety data from postmarketing studies confirm that silicone gel–filled breast implants are safe and effective when used as intended, but women should fully understand the risks prior to considering the implants for breast augmentation or reconstruction.

The data come from a report released June 22 by the Food and Drug Administration that updates the clinical and scientific information for silicone implants.

"Our review of this information continues to support the safety and effectiveness of silicone gel–filled implants when used as intended," Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said during a press briefing. "We also want women to fully understand the risks and complications associated with these implants prior to considering them for breast augmentation or reconstruction."

As part of the FDA’s November 2006 approval of two silicone gel–filled breast implants (the Allergan Natrelle and the Mentor MemoryGel), each manufacturer was required to conduct postapproval studies to characterize the long-term performance and safety of the devices.

In January 2011, the agency issued a statement about a possible but small association between silicone implants and anaplastic large cell lymphoma (ALCL).

The FDA’s new "Update on the Safety of Silicone Gel-Filled Breast Implants" provides a clinical update on the two silicone gel–filled breast implants available in the United States. The updated information includes preliminary data from the postapproval studies, a summary and analysis of adverse events reported to the FDA since approval, and a review and analysis of recent clinical publications about the safety and effectiveness of silicone gel–filled breast implants.

"I do want to emphasize today [that these data are] preliminary and that there are many more years of data collection needed to complete the required 10-year studies," said Dr. Shuren. The report is not intended to provide a comprehensive clinical update about the safety of saline-filled breast implants.

Based on this report, according to the FDA news release, women should know the following:

• Breast implants are not lifetime devices. The longer a woman has silicone gel–filled breast implants, the more likely she is to experience complications. One in five patients who receives implants for breast augmentation will need them removed within 10 years of implantation. For patients who receive implants for breast reconstruction, as many as one in two will require removal 10 years after implantation.

• The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation (additional surgeries), and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection.

• The complications that existed for women who received breast implants at the time of approval are similar to the complications observed today.

• Preliminary data do not indicate that silicone gel–filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer in duration than those conducted thus far.

The FDA will be holding an expert advisory panel in the next few months to discuss how postapproval studies on breast implants can be more effective. For now, the agency is recommending that health care professionals and women who have silicone gel–filled breast implants do the following:

• Follow up. Women should continue to routinely follow up with their health care professionals. This includes getting routine MRIs to detect silent rupture. Dr. Shuren noted that the first MRI should occur at 3 years post implantation and every 2 years after that.

• Be aware. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring, and infection.

• Pay attention to changes. Women should notify their health care professionals if they develop any unusual symptoms. All serious side effects should be reported to the breast implant manufacturer and Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.

• Stay in touch. If a woman has enrolled in a manufacturer-sponsored postapproval study, she should continue to participate. These studies are the best way to collect information about the long-term rates of complications.

The agency also redesigned its website to include comprehensive information on silicone gel–filled and saline-filled breast implants.

For more information, view the "Executive Summary," the "Breast Implants: Consumer Update," and "Things to Consider, Before You Get Breast Implants."

Preliminary safety data from postmarketing studies confirm that silicone gel–filled breast implants are safe and effective when used as intended, but women should fully understand the risks prior to considering the implants for breast augmentation or reconstruction.

The data come from a report released June 22 by the Food and Drug Administration that updates the clinical and scientific information for silicone implants.

"Our review of this information continues to support the safety and effectiveness of silicone gel–filled implants when used as intended," Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said during a press briefing. "We also want women to fully understand the risks and complications associated with these implants prior to considering them for breast augmentation or reconstruction."

As part of the FDA’s November 2006 approval of two silicone gel–filled breast implants (the Allergan Natrelle and the Mentor MemoryGel), each manufacturer was required to conduct postapproval studies to characterize the long-term performance and safety of the devices.

In January 2011, the agency issued a statement about a possible but small association between silicone implants and anaplastic large cell lymphoma (ALCL).

The FDA’s new "Update on the Safety of Silicone Gel-Filled Breast Implants" provides a clinical update on the two silicone gel–filled breast implants available in the United States. The updated information includes preliminary data from the postapproval studies, a summary and analysis of adverse events reported to the FDA since approval, and a review and analysis of recent clinical publications about the safety and effectiveness of silicone gel–filled breast implants.

"I do want to emphasize today [that these data are] preliminary and that there are many more years of data collection needed to complete the required 10-year studies," said Dr. Shuren. The report is not intended to provide a comprehensive clinical update about the safety of saline-filled breast implants.

Based on this report, according to the FDA news release, women should know the following:

• Breast implants are not lifetime devices. The longer a woman has silicone gel–filled breast implants, the more likely she is to experience complications. One in five patients who receives implants for breast augmentation will need them removed within 10 years of implantation. For patients who receive implants for breast reconstruction, as many as one in two will require removal 10 years after implantation.

• The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation (additional surgeries), and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection.

• The complications that existed for women who received breast implants at the time of approval are similar to the complications observed today.

• Preliminary data do not indicate that silicone gel–filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer in duration than those conducted thus far.

The FDA will be holding an expert advisory panel in the next few months to discuss how postapproval studies on breast implants can be more effective. For now, the agency is recommending that health care professionals and women who have silicone gel–filled breast implants do the following:

• Follow up. Women should continue to routinely follow up with their health care professionals. This includes getting routine MRIs to detect silent rupture. Dr. Shuren noted that the first MRI should occur at 3 years post implantation and every 2 years after that.

• Be aware. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring, and infection.

• Pay attention to changes. Women should notify their health care professionals if they develop any unusual symptoms. All serious side effects should be reported to the breast implant manufacturer and Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.

• Stay in touch. If a woman has enrolled in a manufacturer-sponsored postapproval study, she should continue to participate. These studies are the best way to collect information about the long-term rates of complications.

The agency also redesigned its website to include comprehensive information on silicone gel–filled and saline-filled breast implants.

For more information, view the "Executive Summary," the "Breast Implants: Consumer Update," and "Things to Consider, Before You Get Breast Implants."

Preliminary safety data from postmarketing studies confirm that silicone gel–filled breast implants are safe and effective when used as intended, but women should fully understand the risks prior to considering the implants for breast augmentation or reconstruction.

The data come from a report released June 22 by the Food and Drug Administration that updates the clinical and scientific information for silicone implants.

"Our review of this information continues to support the safety and effectiveness of silicone gel–filled implants when used as intended," Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said during a press briefing. "We also want women to fully understand the risks and complications associated with these implants prior to considering them for breast augmentation or reconstruction."

As part of the FDA’s November 2006 approval of two silicone gel–filled breast implants (the Allergan Natrelle and the Mentor MemoryGel), each manufacturer was required to conduct postapproval studies to characterize the long-term performance and safety of the devices.

In January 2011, the agency issued a statement about a possible but small association between silicone implants and anaplastic large cell lymphoma (ALCL).

The FDA’s new "Update on the Safety of Silicone Gel-Filled Breast Implants" provides a clinical update on the two silicone gel–filled breast implants available in the United States. The updated information includes preliminary data from the postapproval studies, a summary and analysis of adverse events reported to the FDA since approval, and a review and analysis of recent clinical publications about the safety and effectiveness of silicone gel–filled breast implants.

"I do want to emphasize today [that these data are] preliminary and that there are many more years of data collection needed to complete the required 10-year studies," said Dr. Shuren. The report is not intended to provide a comprehensive clinical update about the safety of saline-filled breast implants.

Based on this report, according to the FDA news release, women should know the following:

• Breast implants are not lifetime devices. The longer a woman has silicone gel–filled breast implants, the more likely she is to experience complications. One in five patients who receives implants for breast augmentation will need them removed within 10 years of implantation. For patients who receive implants for breast reconstruction, as many as one in two will require removal 10 years after implantation.

• The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation (additional surgeries), and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection.

• The complications that existed for women who received breast implants at the time of approval are similar to the complications observed today.

• Preliminary data do not indicate that silicone gel–filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer in duration than those conducted thus far.

The FDA will be holding an expert advisory panel in the next few months to discuss how postapproval studies on breast implants can be more effective. For now, the agency is recommending that health care professionals and women who have silicone gel–filled breast implants do the following:

• Follow up. Women should continue to routinely follow up with their health care professionals. This includes getting routine MRIs to detect silent rupture. Dr. Shuren noted that the first MRI should occur at 3 years post implantation and every 2 years after that.

• Be aware. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring, and infection.

• Pay attention to changes. Women should notify their health care professionals if they develop any unusual symptoms. All serious side effects should be reported to the breast implant manufacturer and Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.

• Stay in touch. If a woman has enrolled in a manufacturer-sponsored postapproval study, she should continue to participate. These studies are the best way to collect information about the long-term rates of complications.

The agency also redesigned its website to include comprehensive information on silicone gel–filled and saline-filled breast implants.

For more information, view the "Executive Summary," the "Breast Implants: Consumer Update," and "Things to Consider, Before You Get Breast Implants."

Preliminary safety data from postmarketing studies confirm that silicone gel–filled breast implants are safe and effective when used as intended, but women should fully understand the risks prior to considering the implants for breast augmentation or reconstruction.

The data come from a report released June 22 by the Food and Drug Administration that updates the clinical and scientific information for silicone implants.

"Our review of this information continues to support the safety and effectiveness of silicone gel–filled implants when used as intended," Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said during a press briefing. "We also want women to fully understand the risks and complications associated with these implants prior to considering them for breast augmentation or reconstruction."

As part of the FDA’s November 2006 approval of two silicone gel–filled breast implants (the Allergan Natrelle and the Mentor MemoryGel), each manufacturer was required to conduct postapproval studies to characterize the long-term performance and safety of the devices.

In January 2011, the agency issued a statement about a possible but small association between silicone implants and anaplastic large cell lymphoma (ALCL).

The FDA’s new "Update on the Safety of Silicone Gel-Filled Breast Implants" provides a clinical update on the two silicone gel–filled breast implants available in the United States. The updated information includes preliminary data from the postapproval studies, a summary and analysis of adverse events reported to the FDA since approval, and a review and analysis of recent clinical publications about the safety and effectiveness of silicone gel–filled breast implants.

"I do want to emphasize today [that these data are] preliminary and that there are many more years of data collection needed to complete the required 10-year studies," said Dr. Shuren. The report is not intended to provide a comprehensive clinical update about the safety of saline-filled breast implants.

Based on this report, according to the FDA news release, women should know the following:

• Breast implants are not lifetime devices. The longer a woman has silicone gel–filled breast implants, the more likely she is to experience complications. One in five patients who receives implants for breast augmentation will need them removed within 10 years of implantation. For patients who receive implants for breast reconstruction, as many as one in two will require removal 10 years after implantation.

• The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation (additional surgeries), and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection.

• The complications that existed for women who received breast implants at the time of approval are similar to the complications observed today.

• Preliminary data do not indicate that silicone gel–filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer in duration than those conducted thus far.

The FDA will be holding an expert advisory panel in the next few months to discuss how postapproval studies on breast implants can be more effective. For now, the agency is recommending that health care professionals and women who have silicone gel–filled breast implants do the following:

• Follow up. Women should continue to routinely follow up with their health care professionals. This includes getting routine MRIs to detect silent rupture. Dr. Shuren noted that the first MRI should occur at 3 years post implantation and every 2 years after that.

• Be aware. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring, and infection.

• Pay attention to changes. Women should notify their health care professionals if they develop any unusual symptoms. All serious side effects should be reported to the breast implant manufacturer and Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.

• Stay in touch. If a woman has enrolled in a manufacturer-sponsored postapproval study, she should continue to participate. These studies are the best way to collect information about the long-term rates of complications.

The agency also redesigned its website to include comprehensive information on silicone gel–filled and saline-filled breast implants.

For more information, view the "Executive Summary," the "Breast Implants: Consumer Update," and "Things to Consider, Before You Get Breast Implants."

Preliminary safety data from postmarketing studies confirm that silicone gel–filled breast implants are safe and effective when used as intended, but women should fully understand the risks prior to considering the implants for breast augmentation or reconstruction.

The data come from a report released June 22 by the Food and Drug Administration that updates the clinical and scientific information for silicone implants.

"Our review of this information continues to support the safety and effectiveness of silicone gel–filled implants when used as intended," Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said during a press briefing. "We also want women to fully understand the risks and complications associated with these implants prior to considering them for breast augmentation or reconstruction."

As part of the FDA’s November 2006 approval of two silicone gel–filled breast implants (the Allergan Natrelle and the Mentor MemoryGel), each manufacturer was required to conduct postapproval studies to characterize the long-term performance and safety of the devices.

In January 2011, the agency issued a statement about a possible but small association between silicone implants and anaplastic large cell lymphoma (ALCL).

The FDA’s new "Update on the Safety of Silicone Gel-Filled Breast Implants" provides a clinical update on the two silicone gel–filled breast implants available in the United States. The updated information includes preliminary data from the postapproval studies, a summary and analysis of adverse events reported to the FDA since approval, and a review and analysis of recent clinical publications about the safety and effectiveness of silicone gel–filled breast implants.

"I do want to emphasize today [that these data are] preliminary and that there are many more years of data collection needed to complete the required 10-year studies," said Dr. Shuren. The report is not intended to provide a comprehensive clinical update about the safety of saline-filled breast implants.

Based on this report, according to the FDA news release, women should know the following:

• Breast implants are not lifetime devices. The longer a woman has silicone gel–filled breast implants, the more likely she is to experience complications. One in five patients who receives implants for breast augmentation will need them removed within 10 years of implantation. For patients who receive implants for breast reconstruction, as many as one in two will require removal 10 years after implantation.

• The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation (additional surgeries), and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection.

• The complications that existed for women who received breast implants at the time of approval are similar to the complications observed today.

• Preliminary data do not indicate that silicone gel–filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer in duration than those conducted thus far.

The FDA will be holding an expert advisory panel in the next few months to discuss how postapproval studies on breast implants can be more effective. For now, the agency is recommending that health care professionals and women who have silicone gel–filled breast implants do the following:

• Follow up. Women should continue to routinely follow up with their health care professionals. This includes getting routine MRIs to detect silent rupture. Dr. Shuren noted that the first MRI should occur at 3 years post implantation and every 2 years after that.

• Be aware. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring, and infection.

• Pay attention to changes. Women should notify their health care professionals if they develop any unusual symptoms. All serious side effects should be reported to the breast implant manufacturer and Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.

• Stay in touch. If a woman has enrolled in a manufacturer-sponsored postapproval study, she should continue to participate. These studies are the best way to collect information about the long-term rates of complications.

The agency also redesigned its website to include comprehensive information on silicone gel–filled and saline-filled breast implants.

For more information, view the "Executive Summary," the "Breast Implants: Consumer Update," and "Things to Consider, Before You Get Breast Implants."

Preliminary safety data from postmarketing studies confirm that silicone gel–filled breast implants are safe and effective when used as intended, but women should fully understand the risks prior to considering the implants for breast augmentation or reconstruction.

The data come from a report released June 22 by the Food and Drug Administration that updates the clinical and scientific information for silicone implants.

"Our review of this information continues to support the safety and effectiveness of silicone gel–filled implants when used as intended," Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said during a press briefing. "We also want women to fully understand the risks and complications associated with these implants prior to considering them for breast augmentation or reconstruction."

As part of the FDA’s November 2006 approval of two silicone gel–filled breast implants (the Allergan Natrelle and the Mentor MemoryGel), each manufacturer was required to conduct postapproval studies to characterize the long-term performance and safety of the devices.

In January 2011, the agency issued a statement about a possible but small association between silicone implants and anaplastic large cell lymphoma (ALCL).

The FDA’s new "Update on the Safety of Silicone Gel-Filled Breast Implants" provides a clinical update on the two silicone gel–filled breast implants available in the United States. The updated information includes preliminary data from the postapproval studies, a summary and analysis of adverse events reported to the FDA since approval, and a review and analysis of recent clinical publications about the safety and effectiveness of silicone gel–filled breast implants.

"I do want to emphasize today [that these data are] preliminary and that there are many more years of data collection needed to complete the required 10-year studies," said Dr. Shuren. The report is not intended to provide a comprehensive clinical update about the safety of saline-filled breast implants.

Based on this report, according to the FDA news release, women should know the following:

• Breast implants are not lifetime devices. The longer a woman has silicone gel–filled breast implants, the more likely she is to experience complications. One in five patients who receives implants for breast augmentation will need them removed within 10 years of implantation. For patients who receive implants for breast reconstruction, as many as one in two will require removal 10 years after implantation.

• The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation (additional surgeries), and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection.

• The complications that existed for women who received breast implants at the time of approval are similar to the complications observed today.

• Preliminary data do not indicate that silicone gel–filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer in duration than those conducted thus far.

The FDA will be holding an expert advisory panel in the next few months to discuss how postapproval studies on breast implants can be more effective. For now, the agency is recommending that health care professionals and women who have silicone gel–filled breast implants do the following:

• Follow up. Women should continue to routinely follow up with their health care professionals. This includes getting routine MRIs to detect silent rupture. Dr. Shuren noted that the first MRI should occur at 3 years post implantation and every 2 years after that.

• Be aware. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring, and infection.

• Pay attention to changes. Women should notify their health care professionals if they develop any unusual symptoms. All serious side effects should be reported to the breast implant manufacturer and Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.

• Stay in touch. If a woman has enrolled in a manufacturer-sponsored postapproval study, she should continue to participate. These studies are the best way to collect information about the long-term rates of complications.

The agency also redesigned its website to include comprehensive information on silicone gel–filled and saline-filled breast implants.

For more information, view the "Executive Summary," the "Breast Implants: Consumer Update," and "Things to Consider, Before You Get Breast Implants."

BOSTON – Healthy individuals do not need to be screened for vitamin D deficiency, according to guidelines released today by the Endocrine Society.

"We do not recommend screening for vitamin D deficiency in individuals not at risk. That’s an important message. So we’re recommending screening for those at risk for vitamin D deficiency – those who are obese, African Americans, pregnant and lactating women, patients with malabsorption syndromes, and a whole list that we have provided in the guidelines," lead author Dr. Michael F. Holick said at the annual meeting of the Endocrine Society.

Photo Credit: © Kaspri/Fotolia.com

Dr. Holick headed a task force appointed by the clinical guidelines subcommittee of the Endocrine Society to formulate evidence-based recommendations on vitamin D deficiency. The subcommittee deemed vitamin D deficiency a priority area in need of practice guidelines.

The task force recommended that those at risk for vitamin D deficiency be screened by measuring serum 25-hydroxyvitamin D levels using a reliable assay. Causes of vitamin D deficiency include obesity, fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, a wide range of medications (anticonvulsants and anti–HIV/AIDS drugs), chronic granuloma-forming disorders, some lymphomas, and primary hyperthyroidism.

The guidelines were released at the meeting and will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2011-0385).

The guidelines provide long-awaited recommendations on vitamin D intake and the diagnosis and treatment of vitamin D deficiency. Physicians have struggled for years to delineate how much vitamin D is necessary for different clinical groups, how to measure it and how best to supplement deficiencies.

The task force commissioned the conduct of two systematic reviews of the literature to inform its key recommendations and followed the approach recommended by GRADE, an international group with expertise in development and implementation of evidence-based guidelines.

"All available evidence suggests that children and adults should maintain a blood level of 25(OH)D above 20 ng/mL to prevent rickets and osteomalacia, respectively. However, to maximize vitamin D’s effect on calcium, bone, and muscle metabolism, the 25(OH)D blood level should be above 30 ng/mL," the group wrote.

In the new guidelines, vitamin D deficiency is defined as a 25(OH)D concentration less than 20 ng/mL (50 nmol/L). The task force suggests:

– Infants and children aged 0-1 year require at least 400 IU/day (IU = 25 ng) of vitamin D to maximize bone health.

– Children 1 year and older require at least 600 IU/day.

– Adults aged 19-50 years require at least 600 IU/day.

– Adults aged 50-70 years require at least 600 IU/day.

– Adults 70 years and older require 800 IU/day.

– Pregnant and lactating women require at least 600 IU/day.

The task force also recommends that obese children and adults and children and adults on certain medications (anticonvulsant medications, glucocorticoids, antifungals such as ketoconazole, and medications for AIDS) be given at least 2-3 times more vitamin D for their age group to satisfy their bodies’ vitamin D requirements.

Either vitamin D₂ or vitamin D₃ can be used for the treatment and prevention of vitamin D deficiency. The group recommends that adults who are vitamin D deficient be treated with 50,000 IU of vitamin D₂ or vitamin D₃ once a week for eight weeks or its equivalent of 6,000 IU of vitamin D₂ or vitamin D₃ daily to achieve a blood level of 25(OH)D greater than 30 ng/mL. This should be followed by maintenance therapy of 1,500-2,000 IU/day.

The task force also recommends vitamin D supplementation for fall prevention. "We know that there is sufficient evidence to give vitamin D for fall prevention. It’s well documented that vitamin D is very important for muscle strength," said Dr. Holick, professor of medicine, physiology and biophysics at Boston University.

However, the group does not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventing cardiovascular disease or death or improving quality of life, because there is insufficient evidence.

The task force noted that most individuals do not get adequate vitamin D for a number of reasons. In particular, "there needs to be an appreciation that unprotected sun exposure is the major source of vitamin D for both children and adults and that in the absence of sun exposure it is difficult, if not impossible, to obtain an adequate amount of vitamin D from dietary sources without supplementation to satisfy the body’s requirement. Concerns about melanoma and other types of skin cancer necessitate avoidance of excessive exposure to midday sun," they wrote.

The guidelines are cosponsored by the Canadian Society of Endocrinology and Metabolism and the National Osteoporosis Foundation.

All but one of the authors reported having significant financial relationships with pharmaceutical companies, medical organizations and/or food industry groups.

BOSTON – Healthy individuals do not need to be screened for vitamin D deficiency, according to guidelines released today by the Endocrine Society.

"We do not recommend screening for vitamin D deficiency in individuals not at risk. That’s an important message. So we’re recommending screening for those at risk for vitamin D deficiency – those who are obese, African Americans, pregnant and lactating women, patients with malabsorption syndromes, and a whole list that we have provided in the guidelines," lead author Dr. Michael F. Holick said at the annual meeting of the Endocrine Society.

Photo Credit: © Kaspri/Fotolia.com

Dr. Holick headed a task force appointed by the clinical guidelines subcommittee of the Endocrine Society to formulate evidence-based recommendations on vitamin D deficiency. The subcommittee deemed vitamin D deficiency a priority area in need of practice guidelines.

The task force recommended that those at risk for vitamin D deficiency be screened by measuring serum 25-hydroxyvitamin D levels using a reliable assay. Causes of vitamin D deficiency include obesity, fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, a wide range of medications (anticonvulsants and anti–HIV/AIDS drugs), chronic granuloma-forming disorders, some lymphomas, and primary hyperthyroidism.

The guidelines were released at the meeting and will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2011-0385).

The guidelines provide long-awaited recommendations on vitamin D intake and the diagnosis and treatment of vitamin D deficiency. Physicians have struggled for years to delineate how much vitamin D is necessary for different clinical groups, how to measure it and how best to supplement deficiencies.

The task force commissioned the conduct of two systematic reviews of the literature to inform its key recommendations and followed the approach recommended by GRADE, an international group with expertise in development and implementation of evidence-based guidelines.

"All available evidence suggests that children and adults should maintain a blood level of 25(OH)D above 20 ng/mL to prevent rickets and osteomalacia, respectively. However, to maximize vitamin D’s effect on calcium, bone, and muscle metabolism, the 25(OH)D blood level should be above 30 ng/mL," the group wrote.

In the new guidelines, vitamin D deficiency is defined as a 25(OH)D concentration less than 20 ng/mL (50 nmol/L). The task force suggests:

– Infants and children aged 0-1 year require at least 400 IU/day (IU = 25 ng) of vitamin D to maximize bone health.

– Children 1 year and older require at least 600 IU/day.

– Adults aged 19-50 years require at least 600 IU/day.

– Adults aged 50-70 years require at least 600 IU/day.

– Adults 70 years and older require 800 IU/day.

– Pregnant and lactating women require at least 600 IU/day.

The task force also recommends that obese children and adults and children and adults on certain medications (anticonvulsant medications, glucocorticoids, antifungals such as ketoconazole, and medications for AIDS) be given at least 2-3 times more vitamin D for their age group to satisfy their bodies’ vitamin D requirements.

Either vitamin D₂ or vitamin D₃ can be used for the treatment and prevention of vitamin D deficiency. The group recommends that adults who are vitamin D deficient be treated with 50,000 IU of vitamin D₂ or vitamin D₃ once a week for eight weeks or its equivalent of 6,000 IU of vitamin D₂ or vitamin D₃ daily to achieve a blood level of 25(OH)D greater than 30 ng/mL. This should be followed by maintenance therapy of 1,500-2,000 IU/day.

The task force also recommends vitamin D supplementation for fall prevention. "We know that there is sufficient evidence to give vitamin D for fall prevention. It’s well documented that vitamin D is very important for muscle strength," said Dr. Holick, professor of medicine, physiology and biophysics at Boston University.

However, the group does not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventing cardiovascular disease or death or improving quality of life, because there is insufficient evidence.

The task force noted that most individuals do not get adequate vitamin D for a number of reasons. In particular, "there needs to be an appreciation that unprotected sun exposure is the major source of vitamin D for both children and adults and that in the absence of sun exposure it is difficult, if not impossible, to obtain an adequate amount of vitamin D from dietary sources without supplementation to satisfy the body’s requirement. Concerns about melanoma and other types of skin cancer necessitate avoidance of excessive exposure to midday sun," they wrote.

The guidelines are cosponsored by the Canadian Society of Endocrinology and Metabolism and the National Osteoporosis Foundation.

All but one of the authors reported having significant financial relationships with pharmaceutical companies, medical organizations and/or food industry groups.

BOSTON – Healthy individuals do not need to be screened for vitamin D deficiency, according to guidelines released today by the Endocrine Society.

"We do not recommend screening for vitamin D deficiency in individuals not at risk. That’s an important message. So we’re recommending screening for those at risk for vitamin D deficiency – those who are obese, African Americans, pregnant and lactating women, patients with malabsorption syndromes, and a whole list that we have provided in the guidelines," lead author Dr. Michael F. Holick said at the annual meeting of the Endocrine Society.

Photo Credit: © Kaspri/Fotolia.com

Dr. Holick headed a task force appointed by the clinical guidelines subcommittee of the Endocrine Society to formulate evidence-based recommendations on vitamin D deficiency. The subcommittee deemed vitamin D deficiency a priority area in need of practice guidelines.

The task force recommended that those at risk for vitamin D deficiency be screened by measuring serum 25-hydroxyvitamin D levels using a reliable assay. Causes of vitamin D deficiency include obesity, fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, a wide range of medications (anticonvulsants and anti–HIV/AIDS drugs), chronic granuloma-forming disorders, some lymphomas, and primary hyperthyroidism.

The guidelines were released at the meeting and will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2011-0385).

The guidelines provide long-awaited recommendations on vitamin D intake and the diagnosis and treatment of vitamin D deficiency. Physicians have struggled for years to delineate how much vitamin D is necessary for different clinical groups, how to measure it and how best to supplement deficiencies.

The task force commissioned the conduct of two systematic reviews of the literature to inform its key recommendations and followed the approach recommended by GRADE, an international group with expertise in development and implementation of evidence-based guidelines.

"All available evidence suggests that children and adults should maintain a blood level of 25(OH)D above 20 ng/mL to prevent rickets and osteomalacia, respectively. However, to maximize vitamin D’s effect on calcium, bone, and muscle metabolism, the 25(OH)D blood level should be above 30 ng/mL," the group wrote.

In the new guidelines, vitamin D deficiency is defined as a 25(OH)D concentration less than 20 ng/mL (50 nmol/L). The task force suggests:

– Infants and children aged 0-1 year require at least 400 IU/day (IU = 25 ng) of vitamin D to maximize bone health.

– Children 1 year and older require at least 600 IU/day.

– Adults aged 19-50 years require at least 600 IU/day.

– Adults aged 50-70 years require at least 600 IU/day.

– Adults 70 years and older require 800 IU/day.

– Pregnant and lactating women require at least 600 IU/day.

The task force also recommends that obese children and adults and children and adults on certain medications (anticonvulsant medications, glucocorticoids, antifungals such as ketoconazole, and medications for AIDS) be given at least 2-3 times more vitamin D for their age group to satisfy their bodies’ vitamin D requirements.

Either vitamin D₂ or vitamin D₃ can be used for the treatment and prevention of vitamin D deficiency. The group recommends that adults who are vitamin D deficient be treated with 50,000 IU of vitamin D₂ or vitamin D₃ once a week for eight weeks or its equivalent of 6,000 IU of vitamin D₂ or vitamin D₃ daily to achieve a blood level of 25(OH)D greater than 30 ng/mL. This should be followed by maintenance therapy of 1,500-2,000 IU/day.

The task force also recommends vitamin D supplementation for fall prevention. "We know that there is sufficient evidence to give vitamin D for fall prevention. It’s well documented that vitamin D is very important for muscle strength," said Dr. Holick, professor of medicine, physiology and biophysics at Boston University.

However, the group does not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventing cardiovascular disease or death or improving quality of life, because there is insufficient evidence.

The task force noted that most individuals do not get adequate vitamin D for a number of reasons. In particular, "there needs to be an appreciation that unprotected sun exposure is the major source of vitamin D for both children and adults and that in the absence of sun exposure it is difficult, if not impossible, to obtain an adequate amount of vitamin D from dietary sources without supplementation to satisfy the body’s requirement. Concerns about melanoma and other types of skin cancer necessitate avoidance of excessive exposure to midday sun," they wrote.

The guidelines are cosponsored by the Canadian Society of Endocrinology and Metabolism and the National Osteoporosis Foundation.

All but one of the authors reported having significant financial relationships with pharmaceutical companies, medical organizations and/or food industry groups.

BOSTON – Healthy individuals do not need to be screened for vitamin D deficiency, according to guidelines released today by the Endocrine Society.

"We do not recommend screening for vitamin D deficiency in individuals not at risk. That’s an important message. So we’re recommending screening for those at risk for vitamin D deficiency – those who are obese, African Americans, pregnant and lactating women, patients with malabsorption syndromes, and a whole list that we have provided in the guidelines," lead author Dr. Michael F. Holick said at the annual meeting of the Endocrine Society.

Photo Credit: © Kaspri/Fotolia.com

Dr. Holick headed a task force appointed by the clinical guidelines subcommittee of the Endocrine Society to formulate evidence-based recommendations on vitamin D deficiency. The subcommittee deemed vitamin D deficiency a priority area in need of practice guidelines.

The task force recommended that those at risk for vitamin D deficiency be screened by measuring serum 25-hydroxyvitamin D levels using a reliable assay. Causes of vitamin D deficiency include obesity, fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, a wide range of medications (anticonvulsants and anti–HIV/AIDS drugs), chronic granuloma-forming disorders, some lymphomas, and primary hyperthyroidism.

The guidelines were released at the meeting and will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2011-0385).

The guidelines provide long-awaited recommendations on vitamin D intake and the diagnosis and treatment of vitamin D deficiency. Physicians have struggled for years to delineate how much vitamin D is necessary for different clinical groups, how to measure it and how best to supplement deficiencies.

The task force commissioned the conduct of two systematic reviews of the literature to inform its key recommendations and followed the approach recommended by GRADE, an international group with expertise in development and implementation of evidence-based guidelines.

"All available evidence suggests that children and adults should maintain a blood level of 25(OH)D above 20 ng/mL to prevent rickets and osteomalacia, respectively. However, to maximize vitamin D’s effect on calcium, bone, and muscle metabolism, the 25(OH)D blood level should be above 30 ng/mL," the group wrote.

In the new guidelines, vitamin D deficiency is defined as a 25(OH)D concentration less than 20 ng/mL (50 nmol/L). The task force suggests:

– Infants and children aged 0-1 year require at least 400 IU/day (IU = 25 ng) of vitamin D to maximize bone health.

– Children 1 year and older require at least 600 IU/day.

– Adults aged 19-50 years require at least 600 IU/day.

– Adults aged 50-70 years require at least 600 IU/day.

– Adults 70 years and older require 800 IU/day.

– Pregnant and lactating women require at least 600 IU/day.

The task force also recommends that obese children and adults and children and adults on certain medications (anticonvulsant medications, glucocorticoids, antifungals such as ketoconazole, and medications for AIDS) be given at least 2-3 times more vitamin D for their age group to satisfy their bodies’ vitamin D requirements.

Either vitamin D₂ or vitamin D₃ can be used for the treatment and prevention of vitamin D deficiency. The group recommends that adults who are vitamin D deficient be treated with 50,000 IU of vitamin D₂ or vitamin D₃ once a week for eight weeks or its equivalent of 6,000 IU of vitamin D₂ or vitamin D₃ daily to achieve a blood level of 25(OH)D greater than 30 ng/mL. This should be followed by maintenance therapy of 1,500-2,000 IU/day.

The task force also recommends vitamin D supplementation for fall prevention. "We know that there is sufficient evidence to give vitamin D for fall prevention. It’s well documented that vitamin D is very important for muscle strength," said Dr. Holick, professor of medicine, physiology and biophysics at Boston University.

However, the group does not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventing cardiovascular disease or death or improving quality of life, because there is insufficient evidence.

The task force noted that most individuals do not get adequate vitamin D for a number of reasons. In particular, "there needs to be an appreciation that unprotected sun exposure is the major source of vitamin D for both children and adults and that in the absence of sun exposure it is difficult, if not impossible, to obtain an adequate amount of vitamin D from dietary sources without supplementation to satisfy the body’s requirement. Concerns about melanoma and other types of skin cancer necessitate avoidance of excessive exposure to midday sun," they wrote.

The guidelines are cosponsored by the Canadian Society of Endocrinology and Metabolism and the National Osteoporosis Foundation.

All but one of the authors reported having significant financial relationships with pharmaceutical companies, medical organizations and/or food industry groups.

BOSTON – Healthy individuals do not need to be screened for vitamin D deficiency, according to guidelines released today by the Endocrine Society.

"We do not recommend screening for vitamin D deficiency in individuals not at risk. That’s an important message. So we’re recommending screening for those at risk for vitamin D deficiency – those who are obese, African Americans, pregnant and lactating women, patients with malabsorption syndromes, and a whole list that we have provided in the guidelines," lead author Dr. Michael F. Holick said at the annual meeting of the Endocrine Society.

Photo Credit: © Kaspri/Fotolia.com

Dr. Holick headed a task force appointed by the clinical guidelines subcommittee of the Endocrine Society to formulate evidence-based recommendations on vitamin D deficiency. The subcommittee deemed vitamin D deficiency a priority area in need of practice guidelines.

The task force recommended that those at risk for vitamin D deficiency be screened by measuring serum 25-hydroxyvitamin D levels using a reliable assay. Causes of vitamin D deficiency include obesity, fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, a wide range of medications (anticonvulsants and anti–HIV/AIDS drugs), chronic granuloma-forming disorders, some lymphomas, and primary hyperthyroidism.

The guidelines were released at the meeting and will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2011-0385).

The guidelines provide long-awaited recommendations on vitamin D intake and the diagnosis and treatment of vitamin D deficiency. Physicians have struggled for years to delineate how much vitamin D is necessary for different clinical groups, how to measure it and how best to supplement deficiencies.

The task force commissioned the conduct of two systematic reviews of the literature to inform its key recommendations and followed the approach recommended by GRADE, an international group with expertise in development and implementation of evidence-based guidelines.

"All available evidence suggests that children and adults should maintain a blood level of 25(OH)D above 20 ng/mL to prevent rickets and osteomalacia, respectively. However, to maximize vitamin D’s effect on calcium, bone, and muscle metabolism, the 25(OH)D blood level should be above 30 ng/mL," the group wrote.

In the new guidelines, vitamin D deficiency is defined as a 25(OH)D concentration less than 20 ng/mL (50 nmol/L). The task force suggests:

– Infants and children aged 0-1 year require at least 400 IU/day (IU = 25 ng) of vitamin D to maximize bone health.

– Children 1 year and older require at least 600 IU/day.

– Adults aged 19-50 years require at least 600 IU/day.

– Adults aged 50-70 years require at least 600 IU/day.

– Adults 70 years and older require 800 IU/day.

– Pregnant and lactating women require at least 600 IU/day.

The task force also recommends that obese children and adults and children and adults on certain medications (anticonvulsant medications, glucocorticoids, antifungals such as ketoconazole, and medications for AIDS) be given at least 2-3 times more vitamin D for their age group to satisfy their bodies’ vitamin D requirements.

Either vitamin D₂ or vitamin D₃ can be used for the treatment and prevention of vitamin D deficiency. The group recommends that adults who are vitamin D deficient be treated with 50,000 IU of vitamin D₂ or vitamin D₃ once a week for eight weeks or its equivalent of 6,000 IU of vitamin D₂ or vitamin D₃ daily to achieve a blood level of 25(OH)D greater than 30 ng/mL. This should be followed by maintenance therapy of 1,500-2,000 IU/day.

The task force also recommends vitamin D supplementation for fall prevention. "We know that there is sufficient evidence to give vitamin D for fall prevention. It’s well documented that vitamin D is very important for muscle strength," said Dr. Holick, professor of medicine, physiology and biophysics at Boston University.

However, the group does not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventing cardiovascular disease or death or improving quality of life, because there is insufficient evidence.

The task force noted that most individuals do not get adequate vitamin D for a number of reasons. In particular, "there needs to be an appreciation that unprotected sun exposure is the major source of vitamin D for both children and adults and that in the absence of sun exposure it is difficult, if not impossible, to obtain an adequate amount of vitamin D from dietary sources without supplementation to satisfy the body’s requirement. Concerns about melanoma and other types of skin cancer necessitate avoidance of excessive exposure to midday sun," they wrote.

The guidelines are cosponsored by the Canadian Society of Endocrinology and Metabolism and the National Osteoporosis Foundation.

All but one of the authors reported having significant financial relationships with pharmaceutical companies, medical organizations and/or food industry groups.

BOSTON – Healthy individuals do not need to be screened for vitamin D deficiency, according to guidelines released today by the Endocrine Society.

"We do not recommend screening for vitamin D deficiency in individuals not at risk. That’s an important message. So we’re recommending screening for those at risk for vitamin D deficiency – those who are obese, African Americans, pregnant and lactating women, patients with malabsorption syndromes, and a whole list that we have provided in the guidelines," lead author Dr. Michael F. Holick said at the annual meeting of the Endocrine Society.

Photo Credit: © Kaspri/Fotolia.com

Dr. Holick headed a task force appointed by the clinical guidelines subcommittee of the Endocrine Society to formulate evidence-based recommendations on vitamin D deficiency. The subcommittee deemed vitamin D deficiency a priority area in need of practice guidelines.

The task force recommended that those at risk for vitamin D deficiency be screened by measuring serum 25-hydroxyvitamin D levels using a reliable assay. Causes of vitamin D deficiency include obesity, fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, a wide range of medications (anticonvulsants and anti–HIV/AIDS drugs), chronic granuloma-forming disorders, some lymphomas, and primary hyperthyroidism.

The guidelines were released at the meeting and will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2011-0385).

The guidelines provide long-awaited recommendations on vitamin D intake and the diagnosis and treatment of vitamin D deficiency. Physicians have struggled for years to delineate how much vitamin D is necessary for different clinical groups, how to measure it and how best to supplement deficiencies.

The task force commissioned the conduct of two systematic reviews of the literature to inform its key recommendations and followed the approach recommended by GRADE, an international group with expertise in development and implementation of evidence-based guidelines.

"All available evidence suggests that children and adults should maintain a blood level of 25(OH)D above 20 ng/mL to prevent rickets and osteomalacia, respectively. However, to maximize vitamin D’s effect on calcium, bone, and muscle metabolism, the 25(OH)D blood level should be above 30 ng/mL," the group wrote.

In the new guidelines, vitamin D deficiency is defined as a 25(OH)D concentration less than 20 ng/mL (50 nmol/L). The task force suggests:

– Infants and children aged 0-1 year require at least 400 IU/day (IU = 25 ng) of vitamin D to maximize bone health.

– Children 1 year and older require at least 600 IU/day.

– Adults aged 19-50 years require at least 600 IU/day.

– Adults aged 50-70 years require at least 600 IU/day.

– Adults 70 years and older require 800 IU/day.

– Pregnant and lactating women require at least 600 IU/day.

The task force also recommends that obese children and adults and children and adults on certain medications (anticonvulsant medications, glucocorticoids, antifungals such as ketoconazole, and medications for AIDS) be given at least 2-3 times more vitamin D for their age group to satisfy their bodies’ vitamin D requirements.

Either vitamin D₂ or vitamin D₃ can be used for the treatment and prevention of vitamin D deficiency. The group recommends that adults who are vitamin D deficient be treated with 50,000 IU of vitamin D₂ or vitamin D₃ once a week for eight weeks or its equivalent of 6,000 IU of vitamin D₂ or vitamin D₃ daily to achieve a blood level of 25(OH)D greater than 30 ng/mL. This should be followed by maintenance therapy of 1,500-2,000 IU/day.

The task force also recommends vitamin D supplementation for fall prevention. "We know that there is sufficient evidence to give vitamin D for fall prevention. It’s well documented that vitamin D is very important for muscle strength," said Dr. Holick, professor of medicine, physiology and biophysics at Boston University.

However, the group does not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventing cardiovascular disease or death or improving quality of life, because there is insufficient evidence.

The task force noted that most individuals do not get adequate vitamin D for a number of reasons. In particular, "there needs to be an appreciation that unprotected sun exposure is the major source of vitamin D for both children and adults and that in the absence of sun exposure it is difficult, if not impossible, to obtain an adequate amount of vitamin D from dietary sources without supplementation to satisfy the body’s requirement. Concerns about melanoma and other types of skin cancer necessitate avoidance of excessive exposure to midday sun," they wrote.

The guidelines are cosponsored by the Canadian Society of Endocrinology and Metabolism and the National Osteoporosis Foundation.

All but one of the authors reported having significant financial relationships with pharmaceutical companies, medical organizations and/or food industry groups.

BOSTON – Healthy individuals do not need to be screened for vitamin D deficiency, according to guidelines released today by the Endocrine Society.

"We do not recommend screening for vitamin D deficiency in individuals not at risk. That's an important message. So we're recommending screening for those at risk for vitamin D deficiency – those who are obese, African Americans, pregnant and lactating women, patients with malabsorption syndromes, and a whole list that we have provided in the guidelines," lead author Dr. Michael F. Holick said at the annual meeting of the Endocrine Society.

Photo Credit: © Kaspri/Fotolia.com

Dr. Holick headed a task force appointed by the clinical guidelines subcommittee of the Endocrine Society to formulate evidence-based recommendations on vitamin D deficiency. The subcommittee deemed vitamin D deficiency a priority area in need of practice guidelines.

The task force noted that most individuals do not get adequate vitamin D for a number of reasons. In particular, "there needs to be an appreciation that unprotected sun exposure is the major source of vitamin D for both children and adults and that in the absence of sun exposure it is difficult, if not impossible, to obtain an adequate amount of vitamin D from dietary sources without supplementation to satisfy the body’s requirement. Concerns about melanoma and other types of skin cancer necessitate avoidance of excessive exposure to midday sun," they wrote.

The task force recommended that those at risk for vitamin D deficiency be screened by measuring serum 25-hydroxyvitamin D levels using a reliable assay. Causes of vitamin D deficiency include obesity, fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, a wide range of medications (anticonvulsants and anti–HIV/AIDS drugs), chronic granuloma-forming disorders, some lymphomas, and primary hyperthyroidism.

The guidelines were released at the meeting and will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2011-0385).

The guidelines provide long-awaited recommendations on vitamin D intake and the diagnosis and treatment of vitamin D deficiency. Physicians have struggled for years to delineate how much vitamin D is necessary for different clinical groups, how to measure it, and how best to supplement deficiencies.

The task force commissioned the conduct of two systematic reviews of the literature to inform its key recommendations and followed the approach recommended by GRADE, an international group with expertise in development and implementation of evidence-based guidelines.

"All available evidence suggests that children and adults should maintain a blood level of 25(OH)D above 20 ng/mL to prevent rickets and osteomalacia, respectively. However, to maximize vitamin D's effect on calcium, bone, and muscle metabolism, the 25(OH)D blood level should be above 30 ng/mL," the group wrote.

In the new guidelines, vitamin D deficiency is defined as a 25(OH)D concentration less than 20 ng/mL (50 nmol/L). The task force suggests:

– Infants and children aged 0-1 year require at least 400 IU/day (IU = 25 ng) of vitamin D to maximize bone health.

– Children 1 year and older require at least 600 IU/day.

– Adults aged 19-50 years require at least 600 IU/day.

– Adults aged 50-70 years require at least 600 IU/day.

– Adults 70 years and older require 800 IU/day.

– Pregnant and lactating women require at least 600 IU/day.

The task force also recommends that obese children and adults and children and adults on certain medications (anticonvulsant medications, glucocorticoids, antifungals such as ketoconazole, and medications for AIDS) be given at least 2-3 times more vitamin D for their age group to satisfy their bodies' vitamin D requirements.

Either vitamin D₂ or vitamin D₃ can be used for the treatment and prevention of vitamin D deficiency. The group recommends that adults who are vitamin D deficient be treated with 50,000 IU of vitamin D₂ or vitamin D₃ once a week for eight weeks or its equivalent of 6,000 IU of vitamin D₂ or vitamin D₃ daily to achieve a blood level of 25(OH)D greater than 30 ng/mL. This should be followed by maintenance therapy of 1,500-2,000 IU/day.

The task force also recommends vitamin D supplementation for fall prevention. "We know that there is sufficient evidence to give vitamin D for fall prevention. It's well documented that vitamin D is very important for muscle strength," said Dr. Holick, professor of medicine, physiology and biophysics at Boston University.

However, the group does not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventing cardiovascular disease or death or improving quality of life, because there is insufficient evidence.

The guidelines are cosponsored by the Canadian Society of Endocrinology and Metabolism and the National Osteoporosis Foundation.

All but one of the authors reported having significant financial relationships with pharmaceutical companies, medical organizations, and/or food industry groups.

BOSTON – Healthy individuals do not need to be screened for vitamin D deficiency, according to guidelines released today by the Endocrine Society.

"We do not recommend screening for vitamin D deficiency in individuals not at risk. That's an important message. So we're recommending screening for those at risk for vitamin D deficiency – those who are obese, African Americans, pregnant and lactating women, patients with malabsorption syndromes, and a whole list that we have provided in the guidelines," lead author Dr. Michael F. Holick said at the annual meeting of the Endocrine Society.

Photo Credit: © Kaspri/Fotolia.com

Dr. Holick headed a task force appointed by the clinical guidelines subcommittee of the Endocrine Society to formulate evidence-based recommendations on vitamin D deficiency. The subcommittee deemed vitamin D deficiency a priority area in need of practice guidelines.

The task force noted that most individuals do not get adequate vitamin D for a number of reasons. In particular, "there needs to be an appreciation that unprotected sun exposure is the major source of vitamin D for both children and adults and that in the absence of sun exposure it is difficult, if not impossible, to obtain an adequate amount of vitamin D from dietary sources without supplementation to satisfy the body’s requirement. Concerns about melanoma and other types of skin cancer necessitate avoidance of excessive exposure to midday sun," they wrote.

The task force recommended that those at risk for vitamin D deficiency be screened by measuring serum 25-hydroxyvitamin D levels using a reliable assay. Causes of vitamin D deficiency include obesity, fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, a wide range of medications (anticonvulsants and anti–HIV/AIDS drugs), chronic granuloma-forming disorders, some lymphomas, and primary hyperthyroidism.

The guidelines were released at the meeting and will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2011-0385).

The guidelines provide long-awaited recommendations on vitamin D intake and the diagnosis and treatment of vitamin D deficiency. Physicians have struggled for years to delineate how much vitamin D is necessary for different clinical groups, how to measure it, and how best to supplement deficiencies.

The task force commissioned the conduct of two systematic reviews of the literature to inform its key recommendations and followed the approach recommended by GRADE, an international group with expertise in development and implementation of evidence-based guidelines.

"All available evidence suggests that children and adults should maintain a blood level of 25(OH)D above 20 ng/mL to prevent rickets and osteomalacia, respectively. However, to maximize vitamin D's effect on calcium, bone, and muscle metabolism, the 25(OH)D blood level should be above 30 ng/mL," the group wrote.

In the new guidelines, vitamin D deficiency is defined as a 25(OH)D concentration less than 20 ng/mL (50 nmol/L). The task force suggests:

– Infants and children aged 0-1 year require at least 400 IU/day (IU = 25 ng) of vitamin D to maximize bone health.

– Children 1 year and older require at least 600 IU/day.

– Adults aged 19-50 years require at least 600 IU/day.

– Adults aged 50-70 years require at least 600 IU/day.

– Adults 70 years and older require 800 IU/day.

– Pregnant and lactating women require at least 600 IU/day.

The task force also recommends that obese children and adults and children and adults on certain medications (anticonvulsant medications, glucocorticoids, antifungals such as ketoconazole, and medications for AIDS) be given at least 2-3 times more vitamin D for their age group to satisfy their bodies' vitamin D requirements.

Either vitamin D₂ or vitamin D₃ can be used for the treatment and prevention of vitamin D deficiency. The group recommends that adults who are vitamin D deficient be treated with 50,000 IU of vitamin D₂ or vitamin D₃ once a week for eight weeks or its equivalent of 6,000 IU of vitamin D₂ or vitamin D₃ daily to achieve a blood level of 25(OH)D greater than 30 ng/mL. This should be followed by maintenance therapy of 1,500-2,000 IU/day.

The task force also recommends vitamin D supplementation for fall prevention. "We know that there is sufficient evidence to give vitamin D for fall prevention. It's well documented that vitamin D is very important for muscle strength," said Dr. Holick, professor of medicine, physiology and biophysics at Boston University.

However, the group does not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventing cardiovascular disease or death or improving quality of life, because there is insufficient evidence.

The guidelines are cosponsored by the Canadian Society of Endocrinology and Metabolism and the National Osteoporosis Foundation.

All but one of the authors reported having significant financial relationships with pharmaceutical companies, medical organizations, and/or food industry groups.

BOSTON – Healthy individuals do not need to be screened for vitamin D deficiency, according to guidelines released today by the Endocrine Society.

"We do not recommend screening for vitamin D deficiency in individuals not at risk. That's an important message. So we're recommending screening for those at risk for vitamin D deficiency – those who are obese, African Americans, pregnant and lactating women, patients with malabsorption syndromes, and a whole list that we have provided in the guidelines," lead author Dr. Michael F. Holick said at the annual meeting of the Endocrine Society.

Photo Credit: © Kaspri/Fotolia.com

Dr. Holick headed a task force appointed by the clinical guidelines subcommittee of the Endocrine Society to formulate evidence-based recommendations on vitamin D deficiency. The subcommittee deemed vitamin D deficiency a priority area in need of practice guidelines.

The task force noted that most individuals do not get adequate vitamin D for a number of reasons. In particular, "there needs to be an appreciation that unprotected sun exposure is the major source of vitamin D for both children and adults and that in the absence of sun exposure it is difficult, if not impossible, to obtain an adequate amount of vitamin D from dietary sources without supplementation to satisfy the body’s requirement. Concerns about melanoma and other types of skin cancer necessitate avoidance of excessive exposure to midday sun," they wrote.

The task force recommended that those at risk for vitamin D deficiency be screened by measuring serum 25-hydroxyvitamin D levels using a reliable assay. Causes of vitamin D deficiency include obesity, fat malabsorption syndromes, bariatric surgery, nephrotic syndrome, a wide range of medications (anticonvulsants and anti–HIV/AIDS drugs), chronic granuloma-forming disorders, some lymphomas, and primary hyperthyroidism.

The guidelines were released at the meeting and will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2011-0385).

The guidelines provide long-awaited recommendations on vitamin D intake and the diagnosis and treatment of vitamin D deficiency. Physicians have struggled for years to delineate how much vitamin D is necessary for different clinical groups, how to measure it, and how best to supplement deficiencies.

The task force commissioned the conduct of two systematic reviews of the literature to inform its key recommendations and followed the approach recommended by GRADE, an international group with expertise in development and implementation of evidence-based guidelines.

"All available evidence suggests that children and adults should maintain a blood level of 25(OH)D above 20 ng/mL to prevent rickets and osteomalacia, respectively. However, to maximize vitamin D's effect on calcium, bone, and muscle metabolism, the 25(OH)D blood level should be above 30 ng/mL," the group wrote.

In the new guidelines, vitamin D deficiency is defined as a 25(OH)D concentration less than 20 ng/mL (50 nmol/L). The task force suggests:

– Infants and children aged 0-1 year require at least 400 IU/day (IU = 25 ng) of vitamin D to maximize bone health.

– Children 1 year and older require at least 600 IU/day.

– Adults aged 19-50 years require at least 600 IU/day.

– Adults aged 50-70 years require at least 600 IU/day.

– Adults 70 years and older require 800 IU/day.

– Pregnant and lactating women require at least 600 IU/day.

The task force also recommends that obese children and adults and children and adults on certain medications (anticonvulsant medications, glucocorticoids, antifungals such as ketoconazole, and medications for AIDS) be given at least 2-3 times more vitamin D for their age group to satisfy their bodies' vitamin D requirements.

Either vitamin D₂ or vitamin D₃ can be used for the treatment and prevention of vitamin D deficiency. The group recommends that adults who are vitamin D deficient be treated with 50,000 IU of vitamin D₂ or vitamin D₃ once a week for eight weeks or its equivalent of 6,000 IU of vitamin D₂ or vitamin D₃ daily to achieve a blood level of 25(OH)D greater than 30 ng/mL. This should be followed by maintenance therapy of 1,500-2,000 IU/day.

The task force also recommends vitamin D supplementation for fall prevention. "We know that there is sufficient evidence to give vitamin D for fall prevention. It's well documented that vitamin D is very important for muscle strength," said Dr. Holick, professor of medicine, physiology and biophysics at Boston University.

However, the group does not recommend prescribing vitamin D supplementation beyond recommended daily needs for the purpose of preventing cardiovascular disease or death or improving quality of life, because there is insufficient evidence.

The guidelines are cosponsored by the Canadian Society of Endocrinology and Metabolism and the National Osteoporosis Foundation.

All but one of the authors reported having significant financial relationships with pharmaceutical companies, medical organizations, and/or food industry groups.

Neisseria gonorrhoeae cases resistant to azithromycin detected in San Diego led the Centers for Disease Control and Prevention to issue a “Dear Colleague” letter on May 12 reminding clinicians to limit use of azithromycin monotherapy to treat uncomplicated rectal and genitourinary infections caused by N. gonorrhoeae.

Such azithromycin monotherapy typically is used in patients allergic to cephalosporins because recommended treatment for uncomplicated rectal and genitourinary N. gonorrhoeae infection is dual therapy including a 1-g dose of azithromycin and a cephalosporin (250 mg of ceftriaxone or 400 mg of cefixime, if ceftriaxone is not an option).

The resistance concerns are related to five N. gonorrhoeae cases with reduced susceptibility to azithromycin identified in San Diego, the CDC reported.

“The five N. gonorrhoeae infections with high MICs [minimum inhibitory concentrations] to azithromycin identified in MSM [men who have sex with men] during a 3-month period in 2010 in San Diego County amount to an unusually large cluster,” according to the report (MMWR 2011;60:579-81). The infections were identified in MSM with no known connections to each other – prompting concerns that the gonorrhea strains with reduced drug susceptibility might be more widespread in the community. The men presented with symptomatic urethritis.

The five cases were identified between August and October 2009 at San Diego County's main municipal sexually transmitted diseases (STD) clinic. The five isolates had high azithromycin MICs: three with 8 mcg/mL and two with 16 mcg/mL. The five were among 55 (9%) N. gonorrhoeae isolates obtained from men with symptomatic urethritis tested during the 3-month period.

During November 2009 to December 2010, of 229 new isolates obtained from MSM who were examined at the STD clinic, four (1.7%) new isolates at the same clinic were obtained and were found to have high MICs to azithromycin: three with 8 mcg/mL and one with 16 mcg/mL. Through December 2010, no treatment failures had been reported. “Continued surveillance [using culture and susceptibility testing] for antimicrobial resistance in N. gonorrhoeae is essential for effective disease prevention and control,” according to the CDC.

Neisseria gonorrhoeae cases resistant to azithromycin detected in San Diego led the Centers for Disease Control and Prevention to issue a “Dear Colleague” letter on May 12 reminding clinicians to limit use of azithromycin monotherapy to treat uncomplicated rectal and genitourinary infections caused by N. gonorrhoeae.

Such azithromycin monotherapy typically is used in patients allergic to cephalosporins because recommended treatment for uncomplicated rectal and genitourinary N. gonorrhoeae infection is dual therapy including a 1-g dose of azithromycin and a cephalosporin (250 mg of ceftriaxone or 400 mg of cefixime, if ceftriaxone is not an option).

The resistance concerns are related to five N. gonorrhoeae cases with reduced susceptibility to azithromycin identified in San Diego, the CDC reported.

“The five N. gonorrhoeae infections with high MICs [minimum inhibitory concentrations] to azithromycin identified in MSM [men who have sex with men] during a 3-month period in 2010 in San Diego County amount to an unusually large cluster,” according to the report (MMWR 2011;60:579-81). The infections were identified in MSM with no known connections to each other – prompting concerns that the gonorrhea strains with reduced drug susceptibility might be more widespread in the community. The men presented with symptomatic urethritis.

The five cases were identified between August and October 2009 at San Diego County's main municipal sexually transmitted diseases (STD) clinic. The five isolates had high azithromycin MICs: three with 8 mcg/mL and two with 16 mcg/mL. The five were among 55 (9%) N. gonorrhoeae isolates obtained from men with symptomatic urethritis tested during the 3-month period.

During November 2009 to December 2010, of 229 new isolates obtained from MSM who were examined at the STD clinic, four (1.7%) new isolates at the same clinic were obtained and were found to have high MICs to azithromycin: three with 8 mcg/mL and one with 16 mcg/mL. Through December 2010, no treatment failures had been reported. “Continued surveillance [using culture and susceptibility testing] for antimicrobial resistance in N. gonorrhoeae is essential for effective disease prevention and control,” according to the CDC.

Neisseria gonorrhoeae cases resistant to azithromycin detected in San Diego led the Centers for Disease Control and Prevention to issue a “Dear Colleague” letter on May 12 reminding clinicians to limit use of azithromycin monotherapy to treat uncomplicated rectal and genitourinary infections caused by N. gonorrhoeae.

Such azithromycin monotherapy typically is used in patients allergic to cephalosporins because recommended treatment for uncomplicated rectal and genitourinary N. gonorrhoeae infection is dual therapy including a 1-g dose of azithromycin and a cephalosporin (250 mg of ceftriaxone or 400 mg of cefixime, if ceftriaxone is not an option).

The resistance concerns are related to five N. gonorrhoeae cases with reduced susceptibility to azithromycin identified in San Diego, the CDC reported.

“The five N. gonorrhoeae infections with high MICs [minimum inhibitory concentrations] to azithromycin identified in MSM [men who have sex with men] during a 3-month period in 2010 in San Diego County amount to an unusually large cluster,” according to the report (MMWR 2011;60:579-81). The infections were identified in MSM with no known connections to each other – prompting concerns that the gonorrhea strains with reduced drug susceptibility might be more widespread in the community. The men presented with symptomatic urethritis.

The five cases were identified between August and October 2009 at San Diego County's main municipal sexually transmitted diseases (STD) clinic. The five isolates had high azithromycin MICs: three with 8 mcg/mL and two with 16 mcg/mL. The five were among 55 (9%) N. gonorrhoeae isolates obtained from men with symptomatic urethritis tested during the 3-month period.

During November 2009 to December 2010, of 229 new isolates obtained from MSM who were examined at the STD clinic, four (1.7%) new isolates at the same clinic were obtained and were found to have high MICs to azithromycin: three with 8 mcg/mL and one with 16 mcg/mL. Through December 2010, no treatment failures had been reported. “Continued surveillance [using culture and susceptibility testing] for antimicrobial resistance in N. gonorrhoeae is essential for effective disease prevention and control,” according to the CDC.