Whitney McKnight

Magnetic foreign body–related injuries increased significantly between 2002 and 2012, particularly those involving multiple magnet ingestion, according to a retrospective study.

"With the advent of stronger neodymium-iron-boron magnets and their inclusion as part of children’s toys, jewelry, and desk toys, there has been a documented increased in the number of cases resulting in serious morbidity and in rare cases, mortality," Dr. Matt Strickland of the Hospital for Sick Children, Toronto, and his associates, said in a report published online in the Journal of Pediatrics.

Robert Dicks/Lucile Packard Children's Hospital

In a chart review of electronic emergency department (ED) records from a single urban tertiary site between April 1, 2002 and December 31, 2012, of 2,722 patients aged 18 years or younger, 94 were admitted for suspicion of magnet ingestion. In 75 (3%) patients, magnet ingestion was confirmed after removal or by a combination of history and imaging.

In 2010, shortly after smaller, more powerful magnets, often sold in multiples, were introduced to the marketplace, the incidence rate ratio (IRR) of magnet-related injuries increased by a factor of 2.94 (95% confidence interval, 1.84-4.70). Injuries involving multiple magnets increased by a factor of 8.40 (95% CI, 3.44-20.56). Of the confirmed ingestions, 65% were male, with a median age of 4.6 years. The volume of the magnets decreased from 878.6 mm³ to 259.8 mm³ during the years studied, as measured by radiography (P = .04), they reported (J. Pediatr. 2014 May 8 [doi:10.1016/j.jpeds.2014.04.002]).

Dr. Strickland and his associates noted that multiple magnets "pose the unique danger of being able to attract each other through different loops of bowel, arresting their movement, and potentially causing mural pressure necrosis." Six of the cases recorded in the study required the surgical removal of magnets because of intraabdominal sepsis or suspected imminent bowel perforation. Ten cases required endoscopic removal of magnets. Multiple magnet ingestion also can result in fistulas, volvulus, obstruction, and even death, although no deaths were recorded in this study.

Study limitations of note include the possibility that, after 2010, media attention and recalls of products with the magnets might have heightened public sensitivity to the dangers of magnet ingestion, driving up the number of patients admitted to the ED in the latter years of the study period.

The authors of this study did not declare any conflicts of interest.

[email protected]

On Twitter @whitneymcknight

Magnetic foreign body–related injuries increased significantly between 2002 and 2012, particularly those involving multiple magnet ingestion, according to a retrospective study.

"With the advent of stronger neodymium-iron-boron magnets and their inclusion as part of children’s toys, jewelry, and desk toys, there has been a documented increased in the number of cases resulting in serious morbidity and in rare cases, mortality," Dr. Matt Strickland of the Hospital for Sick Children, Toronto, and his associates, said in a report published online in the Journal of Pediatrics.

Robert Dicks/Lucile Packard Children's Hospital

In a chart review of electronic emergency department (ED) records from a single urban tertiary site between April 1, 2002 and December 31, 2012, of 2,722 patients aged 18 years or younger, 94 were admitted for suspicion of magnet ingestion. In 75 (3%) patients, magnet ingestion was confirmed after removal or by a combination of history and imaging.

In 2010, shortly after smaller, more powerful magnets, often sold in multiples, were introduced to the marketplace, the incidence rate ratio (IRR) of magnet-related injuries increased by a factor of 2.94 (95% confidence interval, 1.84-4.70). Injuries involving multiple magnets increased by a factor of 8.40 (95% CI, 3.44-20.56). Of the confirmed ingestions, 65% were male, with a median age of 4.6 years. The volume of the magnets decreased from 878.6 mm³ to 259.8 mm³ during the years studied, as measured by radiography (P = .04), they reported (J. Pediatr. 2014 May 8 [doi:10.1016/j.jpeds.2014.04.002]).

Dr. Strickland and his associates noted that multiple magnets "pose the unique danger of being able to attract each other through different loops of bowel, arresting their movement, and potentially causing mural pressure necrosis." Six of the cases recorded in the study required the surgical removal of magnets because of intraabdominal sepsis or suspected imminent bowel perforation. Ten cases required endoscopic removal of magnets. Multiple magnet ingestion also can result in fistulas, volvulus, obstruction, and even death, although no deaths were recorded in this study.

Study limitations of note include the possibility that, after 2010, media attention and recalls of products with the magnets might have heightened public sensitivity to the dangers of magnet ingestion, driving up the number of patients admitted to the ED in the latter years of the study period.

The authors of this study did not declare any conflicts of interest.

[email protected]

On Twitter @whitneymcknight

Magnetic foreign body–related injuries increased significantly between 2002 and 2012, particularly those involving multiple magnet ingestion, according to a retrospective study.

"With the advent of stronger neodymium-iron-boron magnets and their inclusion as part of children’s toys, jewelry, and desk toys, there has been a documented increased in the number of cases resulting in serious morbidity and in rare cases, mortality," Dr. Matt Strickland of the Hospital for Sick Children, Toronto, and his associates, said in a report published online in the Journal of Pediatrics.

Robert Dicks/Lucile Packard Children's Hospital

In a chart review of electronic emergency department (ED) records from a single urban tertiary site between April 1, 2002 and December 31, 2012, of 2,722 patients aged 18 years or younger, 94 were admitted for suspicion of magnet ingestion. In 75 (3%) patients, magnet ingestion was confirmed after removal or by a combination of history and imaging.

In 2010, shortly after smaller, more powerful magnets, often sold in multiples, were introduced to the marketplace, the incidence rate ratio (IRR) of magnet-related injuries increased by a factor of 2.94 (95% confidence interval, 1.84-4.70). Injuries involving multiple magnets increased by a factor of 8.40 (95% CI, 3.44-20.56). Of the confirmed ingestions, 65% were male, with a median age of 4.6 years. The volume of the magnets decreased from 878.6 mm³ to 259.8 mm³ during the years studied, as measured by radiography (P = .04), they reported (J. Pediatr. 2014 May 8 [doi:10.1016/j.jpeds.2014.04.002]).

Dr. Strickland and his associates noted that multiple magnets "pose the unique danger of being able to attract each other through different loops of bowel, arresting their movement, and potentially causing mural pressure necrosis." Six of the cases recorded in the study required the surgical removal of magnets because of intraabdominal sepsis or suspected imminent bowel perforation. Ten cases required endoscopic removal of magnets. Multiple magnet ingestion also can result in fistulas, volvulus, obstruction, and even death, although no deaths were recorded in this study.

Study limitations of note include the possibility that, after 2010, media attention and recalls of products with the magnets might have heightened public sensitivity to the dangers of magnet ingestion, driving up the number of patients admitted to the ED in the latter years of the study period.

The authors of this study did not declare any conflicts of interest.

[email protected]

On Twitter @whitneymcknight

NEW ORLEANS – Vertical incisions in morbidly obese women undergoing a primary cesarean delivery are associated with fewer wound complications, compared with transverse incisions.

The findings were "contrary to expectations," presenter Dr. Caroline C. Marrs told an audience at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The registry study of morbidly obese women who had had a primary C-section showed that those with a vertical incision were found to have higher rates of all adverse maternal outcomes, except for transfusions, but had lower incision-to-delivery times (9.2 plus or minus 5.5 vs. 11.1 plus or minus 6.1, P less than .001). "However, there was significant confounder bias, because after adjusting for significant baseline and clinical characteristics such as race, smoking status, and body mass index, vertical incisions were not associated with higher rates of composite maternal morbidity," said Dr. Marrs of the University of Texas Health Science Center in Houston.

Using data collected between 1999 and 2002 for the cesarean registry of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network from 19 academic medical centers, Dr. Marrs and her colleagues identified 3,200 women with a body mass index of 40 kg/m² at the time of their delivery by primary C-section whose incision type was known

The transverse skin incision cohort numbered 2,603 (81%), and the vertical incision group was 597 (19%).

An analysis of patient characteristics indicated the type of incision a woman had positively correlated with her race, smoking status, and insurance type, as well as whether the woman had gestational diabetes, chorioamnionitis, non–lower-segment hysterotomy, and an emergency C-section.

Logistical regression showed that vertical skin incisions were associated with parity (1.16, adjusted odds ratio 1.09-1.25); black race (1.24, AOR 1.03-1.51), maternal body mass index (1.06, AOR 1.04-1.08), low transverse hysterotomy (4.46, AOR 3.21-6.20), and nonemergent cesarean delivery (0.49, AOR 0.39-0.62).

A univariate analysis of composite wound complications such as seroma or hematoma indicated that vertical wounds were more associated with higher complication rates (4.2% of the vertical group vs. 1.7% of the transverse group, P less than .001).

Multivariate progression analysis indicated that the adjusted odds ratio for a vertical incision being a risk factor for wound complications was 0.32 (0.17-62). Other risk factors noted were: nonwhite race (0.48, AOR 0.25 to 0.94), maternal BMI (1.05, AOR 1.00 to 1.09), and ASA score (2.10, AOR 1.21-3.65).

"We suspect selection bias played a role," said Dr. Marrs. "Given the differences in baseline clinical characteristics of women who had vertical incisions, surgeons may have chosen this route based on selected factors such as BMI or need for emergency delivery."

Dr. Marrs did not have any relevant disclosures.

[email protected]

NEW ORLEANS – Vertical incisions in morbidly obese women undergoing a primary cesarean delivery are associated with fewer wound complications, compared with transverse incisions.

The findings were "contrary to expectations," presenter Dr. Caroline C. Marrs told an audience at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The registry study of morbidly obese women who had had a primary C-section showed that those with a vertical incision were found to have higher rates of all adverse maternal outcomes, except for transfusions, but had lower incision-to-delivery times (9.2 plus or minus 5.5 vs. 11.1 plus or minus 6.1, P less than .001). "However, there was significant confounder bias, because after adjusting for significant baseline and clinical characteristics such as race, smoking status, and body mass index, vertical incisions were not associated with higher rates of composite maternal morbidity," said Dr. Marrs of the University of Texas Health Science Center in Houston.

Using data collected between 1999 and 2002 for the cesarean registry of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network from 19 academic medical centers, Dr. Marrs and her colleagues identified 3,200 women with a body mass index of 40 kg/m² at the time of their delivery by primary C-section whose incision type was known

The transverse skin incision cohort numbered 2,603 (81%), and the vertical incision group was 597 (19%).

An analysis of patient characteristics indicated the type of incision a woman had positively correlated with her race, smoking status, and insurance type, as well as whether the woman had gestational diabetes, chorioamnionitis, non–lower-segment hysterotomy, and an emergency C-section.

Logistical regression showed that vertical skin incisions were associated with parity (1.16, adjusted odds ratio 1.09-1.25); black race (1.24, AOR 1.03-1.51), maternal body mass index (1.06, AOR 1.04-1.08), low transverse hysterotomy (4.46, AOR 3.21-6.20), and nonemergent cesarean delivery (0.49, AOR 0.39-0.62).

A univariate analysis of composite wound complications such as seroma or hematoma indicated that vertical wounds were more associated with higher complication rates (4.2% of the vertical group vs. 1.7% of the transverse group, P less than .001).

Multivariate progression analysis indicated that the adjusted odds ratio for a vertical incision being a risk factor for wound complications was 0.32 (0.17-62). Other risk factors noted were: nonwhite race (0.48, AOR 0.25 to 0.94), maternal BMI (1.05, AOR 1.00 to 1.09), and ASA score (2.10, AOR 1.21-3.65).

"We suspect selection bias played a role," said Dr. Marrs. "Given the differences in baseline clinical characteristics of women who had vertical incisions, surgeons may have chosen this route based on selected factors such as BMI or need for emergency delivery."

Dr. Marrs did not have any relevant disclosures.

[email protected]

NEW ORLEANS – Vertical incisions in morbidly obese women undergoing a primary cesarean delivery are associated with fewer wound complications, compared with transverse incisions.

The findings were "contrary to expectations," presenter Dr. Caroline C. Marrs told an audience at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The registry study of morbidly obese women who had had a primary C-section showed that those with a vertical incision were found to have higher rates of all adverse maternal outcomes, except for transfusions, but had lower incision-to-delivery times (9.2 plus or minus 5.5 vs. 11.1 plus or minus 6.1, P less than .001). "However, there was significant confounder bias, because after adjusting for significant baseline and clinical characteristics such as race, smoking status, and body mass index, vertical incisions were not associated with higher rates of composite maternal morbidity," said Dr. Marrs of the University of Texas Health Science Center in Houston.

Using data collected between 1999 and 2002 for the cesarean registry of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network from 19 academic medical centers, Dr. Marrs and her colleagues identified 3,200 women with a body mass index of 40 kg/m² at the time of their delivery by primary C-section whose incision type was known

The transverse skin incision cohort numbered 2,603 (81%), and the vertical incision group was 597 (19%).

An analysis of patient characteristics indicated the type of incision a woman had positively correlated with her race, smoking status, and insurance type, as well as whether the woman had gestational diabetes, chorioamnionitis, non–lower-segment hysterotomy, and an emergency C-section.

Logistical regression showed that vertical skin incisions were associated with parity (1.16, adjusted odds ratio 1.09-1.25); black race (1.24, AOR 1.03-1.51), maternal body mass index (1.06, AOR 1.04-1.08), low transverse hysterotomy (4.46, AOR 3.21-6.20), and nonemergent cesarean delivery (0.49, AOR 0.39-0.62).

A univariate analysis of composite wound complications such as seroma or hematoma indicated that vertical wounds were more associated with higher complication rates (4.2% of the vertical group vs. 1.7% of the transverse group, P less than .001).

Multivariate progression analysis indicated that the adjusted odds ratio for a vertical incision being a risk factor for wound complications was 0.32 (0.17-62). Other risk factors noted were: nonwhite race (0.48, AOR 0.25 to 0.94), maternal BMI (1.05, AOR 1.00 to 1.09), and ASA score (2.10, AOR 1.21-3.65).

"We suspect selection bias played a role," said Dr. Marrs. "Given the differences in baseline clinical characteristics of women who had vertical incisions, surgeons may have chosen this route based on selected factors such as BMI or need for emergency delivery."

Dr. Marrs did not have any relevant disclosures.

[email protected]

PHILADELPHIA – Despite an overall agreement on its merit, both parents and their adolescent daughters are leery of the confidential interview in the gynecologic setting, in part because each cohort believes that it is tantamount to parents being excluded in the teen’s health care decision-making process.

"The majority of parents felt that this was inappropriate for their teen because this was a specialized setting," Dr. Gylynthia E. Trotman, a second-year fellow at Medstar Washington Hospital Center, Children’s National Medical Center, said in an interview.

"The adolescent felt that way, too, which came as a shock to us," Dr. Trotman said during the poster session at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology. "They wanted parents to be a part of their decision making."

Whitney McKnight/Frontline Medical News

The data, derived from a survey of 62 pairs of parents and 62 of their collective adolescent daughters between the ages of 11 and 17 years, showed that while 85% of teens and 78% of parents thought the confidential interview was beneficial, 31% and 40% respectively thought it limited the parents’ role in addressing their child’s health concern. In addition, only half of parents surveyed fully knew and understood the confidentiality policy at their daughter’s clinic.

Only half the parents in the study understood that they would only be informed of the details of the interview if their child assented, or if their child was at serious risk. A third thought they would be informed of what their child revealed, regardless of what the teen wanted. Nearly 20% said they were unsure of the clinic’s policy on confidentiality.

The findings led Dr. Trotman and her colleagues to conclude that gynecologic specialists could do more to educate patients and their families about the confidential interview and improve the efficacy of its delivery.

Meanwhile, despite a third of parents stating that the most appropriate age for confidential interviews to begin was age 17 years, the study also found that the adolescents were engaging in an array of risky behaviors, including but not limited to those to do with sex, as early as age 11 years.

There was parity between what the parents perceived were their daughters’ sexual activity and the percentage of teens who reported being sexually active (12% vs. 15%); however, Dr. Trotman said that while "parents are definitely speaking to their teens more about sex and about drinking alcohol," they were essentially unaware of the extent to which their children were reportedly bullied and/or engaging in self-harm, eating disorders, and other deleterious behaviors.

"At all ages, there was a significant difference between the parents’ perception of their own teen’s [behavior] and what behavior the adolescents [reported]," said Dr. Trotman (P less than or equal to .0001).

"This is the message we try to get across: that the confidential interview is for more than talking about sexual behaviors," said Dr. Trotman.

Dr. Trotman reported no relevant disclosures.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Despite an overall agreement on its merit, both parents and their adolescent daughters are leery of the confidential interview in the gynecologic setting, in part because each cohort believes that it is tantamount to parents being excluded in the teen’s health care decision-making process.

"The majority of parents felt that this was inappropriate for their teen because this was a specialized setting," Dr. Gylynthia E. Trotman, a second-year fellow at Medstar Washington Hospital Center, Children’s National Medical Center, said in an interview.

"The adolescent felt that way, too, which came as a shock to us," Dr. Trotman said during the poster session at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology. "They wanted parents to be a part of their decision making."

Whitney McKnight/Frontline Medical News

The data, derived from a survey of 62 pairs of parents and 62 of their collective adolescent daughters between the ages of 11 and 17 years, showed that while 85% of teens and 78% of parents thought the confidential interview was beneficial, 31% and 40% respectively thought it limited the parents’ role in addressing their child’s health concern. In addition, only half of parents surveyed fully knew and understood the confidentiality policy at their daughter’s clinic.

Only half the parents in the study understood that they would only be informed of the details of the interview if their child assented, or if their child was at serious risk. A third thought they would be informed of what their child revealed, regardless of what the teen wanted. Nearly 20% said they were unsure of the clinic’s policy on confidentiality.

The findings led Dr. Trotman and her colleagues to conclude that gynecologic specialists could do more to educate patients and their families about the confidential interview and improve the efficacy of its delivery.

Meanwhile, despite a third of parents stating that the most appropriate age for confidential interviews to begin was age 17 years, the study also found that the adolescents were engaging in an array of risky behaviors, including but not limited to those to do with sex, as early as age 11 years.

There was parity between what the parents perceived were their daughters’ sexual activity and the percentage of teens who reported being sexually active (12% vs. 15%); however, Dr. Trotman said that while "parents are definitely speaking to their teens more about sex and about drinking alcohol," they were essentially unaware of the extent to which their children were reportedly bullied and/or engaging in self-harm, eating disorders, and other deleterious behaviors.

"At all ages, there was a significant difference between the parents’ perception of their own teen’s [behavior] and what behavior the adolescents [reported]," said Dr. Trotman (P less than or equal to .0001).

"This is the message we try to get across: that the confidential interview is for more than talking about sexual behaviors," said Dr. Trotman.

Dr. Trotman reported no relevant disclosures.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Despite an overall agreement on its merit, both parents and their adolescent daughters are leery of the confidential interview in the gynecologic setting, in part because each cohort believes that it is tantamount to parents being excluded in the teen’s health care decision-making process.

"The majority of parents felt that this was inappropriate for their teen because this was a specialized setting," Dr. Gylynthia E. Trotman, a second-year fellow at Medstar Washington Hospital Center, Children’s National Medical Center, said in an interview.

"The adolescent felt that way, too, which came as a shock to us," Dr. Trotman said during the poster session at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology. "They wanted parents to be a part of their decision making."

Whitney McKnight/Frontline Medical News

The data, derived from a survey of 62 pairs of parents and 62 of their collective adolescent daughters between the ages of 11 and 17 years, showed that while 85% of teens and 78% of parents thought the confidential interview was beneficial, 31% and 40% respectively thought it limited the parents’ role in addressing their child’s health concern. In addition, only half of parents surveyed fully knew and understood the confidentiality policy at their daughter’s clinic.

Only half the parents in the study understood that they would only be informed of the details of the interview if their child assented, or if their child was at serious risk. A third thought they would be informed of what their child revealed, regardless of what the teen wanted. Nearly 20% said they were unsure of the clinic’s policy on confidentiality.

The findings led Dr. Trotman and her colleagues to conclude that gynecologic specialists could do more to educate patients and their families about the confidential interview and improve the efficacy of its delivery.

Meanwhile, despite a third of parents stating that the most appropriate age for confidential interviews to begin was age 17 years, the study also found that the adolescents were engaging in an array of risky behaviors, including but not limited to those to do with sex, as early as age 11 years.

There was parity between what the parents perceived were their daughters’ sexual activity and the percentage of teens who reported being sexually active (12% vs. 15%); however, Dr. Trotman said that while "parents are definitely speaking to their teens more about sex and about drinking alcohol," they were essentially unaware of the extent to which their children were reportedly bullied and/or engaging in self-harm, eating disorders, and other deleterious behaviors.

"At all ages, there was a significant difference between the parents’ perception of their own teen’s [behavior] and what behavior the adolescents [reported]," said Dr. Trotman (P less than or equal to .0001).

"This is the message we try to get across: that the confidential interview is for more than talking about sexual behaviors," said Dr. Trotman.

Dr. Trotman reported no relevant disclosures.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Which comes first, the migraine or the anxiety and depression? At the annual meeting of the American Academy of Neurology, Dr. Deborah Friedman, professor of neurology at the University of Texas Southwestern Medical Center, Dallas, suggests that patients can use cognitive-behavioral therapy rather than medication to best address the migraine-related anxiety and depression, possibly improving their ability to cope with their migraine by allowing them better insight into its impact.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Which comes first, the migraine or the anxiety and depression? At the annual meeting of the American Academy of Neurology, Dr. Deborah Friedman, professor of neurology at the University of Texas Southwestern Medical Center, Dallas, suggests that patients can use cognitive-behavioral therapy rather than medication to best address the migraine-related anxiety and depression, possibly improving their ability to cope with their migraine by allowing them better insight into its impact.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Which comes first, the migraine or the anxiety and depression? At the annual meeting of the American Academy of Neurology, Dr. Deborah Friedman, professor of neurology at the University of Texas Southwestern Medical Center, Dallas, suggests that patients can use cognitive-behavioral therapy rather than medication to best address the migraine-related anxiety and depression, possibly improving their ability to cope with their migraine by allowing them better insight into its impact.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Presumed consent for emergency thrombolysis is ethical and practical, according to the results of a population-based survey.

In an online survey of 1,100 adults aged 50 years or older, 76.9% said they would want intravenous tissue plasminogen activator for stroke. Of those surveyed, 76.0% also said they would want cardiopulmonary resuscitation for cardiac arrest. If they were unable to give informed consent in either situation, the desire for emergency thrombolysis remained essentially unchanged at 78.1%, while even more (83.6%) respondents said they would want CPR, Dr. Winston Chiong reported at the annual meeting of the American Academy of Neurology. The findings also appear in the April 23 issue of JAMA (2014;311:1689-91).

"The presumption is that ‘reasonable people’ in the middle of [an acute ischemic stroke] cascade would want thrombolytic treatment," Dr. Chiong told the platform science session blitz audience. "But this presumption has been controversial because thrombolysis has no short-term mortality benefit, unlike CPR."

In 2011, the AAN endorsed emergency thrombolysis under presumption of consent; in 2013, the American Heart Association and the American Stroke Association followed suit.

Dr. Chiong, whose interest lies in decision making and how it is affected by aging and neurodegenerative disease, said the findings provide empirical data that this presumption is justified.

He and his colleagues at the University of California, San Francisco, Memory and Aging Center randomly assigned survey participants to read one of two hypothetical scenarios. In the first, they saw themselves being brought to a hospital after having a severe acute ischemic stroke. In the second, they saw themselves have an out-of-hospital cardiac arrest that was treated by paramedics.

The stroke group was given a graphical depiction of the potential risks and benefits of treatment with thrombolysis, while the cardiac arrest group was told of the potential outcomes after paramedic-initiated CPR.

Each group was then asked whether they would want the respective treatment for their imagined scenario.

In the stroke group, 419 of 545 participants (76.9%) wanted thrombolysis, while 422 of 555 respondents (76.0%) wanted CPR for sudden cardiac arrest. Female sex, being divorced, and having less education were associated with refusing thrombolysis; poorer physical health, previous stroke, and possession of a health care advance directive was associated with refusal of CPR.

"In a clinical scenario involving an incapacitated patient where the treatment preferences are unknown and no surrogate decision maker can be found within the treatment window, we found equally strong ethical grounds for presuming thrombolysis of stroke as for presumed consent of CPR in cardiac arrest," Dr. Chiong said.

However, he underscored that despite there being a "pragmatic ethical and legal" basis for presumed consent, it is important to remember there are still a quarter of older adults who would not want the treatment if unable to consent.

"I spend a lot of time thinking about these things," he said, "The presumption of consent should not be taken to fully replace informed consent," particularly if there is some existing evidence of the patient’s wishes or if there is some question about the effectiveness of the intervention.

This study was supported in part by the American Brain Foundation Clinical Research Training Fellowship Program and grants from the National Science Foundation, the National Institute on Aging, and the National Center for Advancing Translational Sciences.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Presumed consent for emergency thrombolysis is ethical and practical, according to the results of a population-based survey.

In an online survey of 1,100 adults aged 50 years or older, 76.9% said they would want intravenous tissue plasminogen activator for stroke. Of those surveyed, 76.0% also said they would want cardiopulmonary resuscitation for cardiac arrest. If they were unable to give informed consent in either situation, the desire for emergency thrombolysis remained essentially unchanged at 78.1%, while even more (83.6%) respondents said they would want CPR, Dr. Winston Chiong reported at the annual meeting of the American Academy of Neurology. The findings also appear in the April 23 issue of JAMA (2014;311:1689-91).

"The presumption is that ‘reasonable people’ in the middle of [an acute ischemic stroke] cascade would want thrombolytic treatment," Dr. Chiong told the platform science session blitz audience. "But this presumption has been controversial because thrombolysis has no short-term mortality benefit, unlike CPR."

In 2011, the AAN endorsed emergency thrombolysis under presumption of consent; in 2013, the American Heart Association and the American Stroke Association followed suit.

Dr. Chiong, whose interest lies in decision making and how it is affected by aging and neurodegenerative disease, said the findings provide empirical data that this presumption is justified.

He and his colleagues at the University of California, San Francisco, Memory and Aging Center randomly assigned survey participants to read one of two hypothetical scenarios. In the first, they saw themselves being brought to a hospital after having a severe acute ischemic stroke. In the second, they saw themselves have an out-of-hospital cardiac arrest that was treated by paramedics.

The stroke group was given a graphical depiction of the potential risks and benefits of treatment with thrombolysis, while the cardiac arrest group was told of the potential outcomes after paramedic-initiated CPR.

Each group was then asked whether they would want the respective treatment for their imagined scenario.

In the stroke group, 419 of 545 participants (76.9%) wanted thrombolysis, while 422 of 555 respondents (76.0%) wanted CPR for sudden cardiac arrest. Female sex, being divorced, and having less education were associated with refusing thrombolysis; poorer physical health, previous stroke, and possession of a health care advance directive was associated with refusal of CPR.

"In a clinical scenario involving an incapacitated patient where the treatment preferences are unknown and no surrogate decision maker can be found within the treatment window, we found equally strong ethical grounds for presuming thrombolysis of stroke as for presumed consent of CPR in cardiac arrest," Dr. Chiong said.

However, he underscored that despite there being a "pragmatic ethical and legal" basis for presumed consent, it is important to remember there are still a quarter of older adults who would not want the treatment if unable to consent.

"I spend a lot of time thinking about these things," he said, "The presumption of consent should not be taken to fully replace informed consent," particularly if there is some existing evidence of the patient’s wishes or if there is some question about the effectiveness of the intervention.

This study was supported in part by the American Brain Foundation Clinical Research Training Fellowship Program and grants from the National Science Foundation, the National Institute on Aging, and the National Center for Advancing Translational Sciences.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Presumed consent for emergency thrombolysis is ethical and practical, according to the results of a population-based survey.

In an online survey of 1,100 adults aged 50 years or older, 76.9% said they would want intravenous tissue plasminogen activator for stroke. Of those surveyed, 76.0% also said they would want cardiopulmonary resuscitation for cardiac arrest. If they were unable to give informed consent in either situation, the desire for emergency thrombolysis remained essentially unchanged at 78.1%, while even more (83.6%) respondents said they would want CPR, Dr. Winston Chiong reported at the annual meeting of the American Academy of Neurology. The findings also appear in the April 23 issue of JAMA (2014;311:1689-91).

"The presumption is that ‘reasonable people’ in the middle of [an acute ischemic stroke] cascade would want thrombolytic treatment," Dr. Chiong told the platform science session blitz audience. "But this presumption has been controversial because thrombolysis has no short-term mortality benefit, unlike CPR."

In 2011, the AAN endorsed emergency thrombolysis under presumption of consent; in 2013, the American Heart Association and the American Stroke Association followed suit.

Dr. Chiong, whose interest lies in decision making and how it is affected by aging and neurodegenerative disease, said the findings provide empirical data that this presumption is justified.

He and his colleagues at the University of California, San Francisco, Memory and Aging Center randomly assigned survey participants to read one of two hypothetical scenarios. In the first, they saw themselves being brought to a hospital after having a severe acute ischemic stroke. In the second, they saw themselves have an out-of-hospital cardiac arrest that was treated by paramedics.

The stroke group was given a graphical depiction of the potential risks and benefits of treatment with thrombolysis, while the cardiac arrest group was told of the potential outcomes after paramedic-initiated CPR.

Each group was then asked whether they would want the respective treatment for their imagined scenario.

In the stroke group, 419 of 545 participants (76.9%) wanted thrombolysis, while 422 of 555 respondents (76.0%) wanted CPR for sudden cardiac arrest. Female sex, being divorced, and having less education were associated with refusing thrombolysis; poorer physical health, previous stroke, and possession of a health care advance directive was associated with refusal of CPR.

"In a clinical scenario involving an incapacitated patient where the treatment preferences are unknown and no surrogate decision maker can be found within the treatment window, we found equally strong ethical grounds for presuming thrombolysis of stroke as for presumed consent of CPR in cardiac arrest," Dr. Chiong said.

However, he underscored that despite there being a "pragmatic ethical and legal" basis for presumed consent, it is important to remember there are still a quarter of older adults who would not want the treatment if unable to consent.

"I spend a lot of time thinking about these things," he said, "The presumption of consent should not be taken to fully replace informed consent," particularly if there is some existing evidence of the patient’s wishes or if there is some question about the effectiveness of the intervention.

This study was supported in part by the American Brain Foundation Clinical Research Training Fellowship Program and grants from the National Science Foundation, the National Institute on Aging, and the National Center for Advancing Translational Sciences.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – From biomarkers for better diagnosis to new biologic agents for more effective treatment, multiple sclerosis patients may soon enjoy a wave of promising advances.

In an interview at the annual meeting of the American Academy of Neurology, Dr. Emmanuelle Waubant, professor of neurology at the University of California, San Francisco, talked about progress being made with remyelination therapies and discussed three investigational drugs that could reach the market soon.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – From biomarkers for better diagnosis to new biologic agents for more effective treatment, multiple sclerosis patients may soon enjoy a wave of promising advances.

In an interview at the annual meeting of the American Academy of Neurology, Dr. Emmanuelle Waubant, professor of neurology at the University of California, San Francisco, talked about progress being made with remyelination therapies and discussed three investigational drugs that could reach the market soon.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – From biomarkers for better diagnosis to new biologic agents for more effective treatment, multiple sclerosis patients may soon enjoy a wave of promising advances.

In an interview at the annual meeting of the American Academy of Neurology, Dr. Emmanuelle Waubant, professor of neurology at the University of California, San Francisco, talked about progress being made with remyelination therapies and discussed three investigational drugs that could reach the market soon.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Results of the phase III clinical trial to evaluate preladenant as monotherapy for Parkinson’s disease are difficult to interpret because the lack of observed efficacy of rasagiline as an active control indicates that the study didn’t work.

"There was not a significantly greater benefit in any of the arms, compared with placebo, including all the preladenant arms, and the rasagiline arm, our active-control medication with known efficacy," Dr. Robert A. Hauser revealed to a giggling crowd, some of whom applauded, at the annual meeting of the American Academy of Neurology.

"Interestingly enough, placebo was statistically superior to the lowest dose of preladenant," said Dr. Hauser, director of the Parkinson’s Disease and Movement Disorder Center at the University of South Florida, Tampa.

The randomized, double-blind, placebo- and active-controlled, parallel-group trial was designed to cover two 26-week time periods for a total of 52 weeks, and it was conducted at multiple centers in multiple countries. More than half (58%) of the 1,022 participants were men. The average age was 63 years, and the mean baseline score on the Unified Parkinson’s Disease Rating Scale (UPDRS) parts 2 and 3 was 28.5. The study participants had been diagnosed with Parkinson’s disease within the previous 5 years, and had not yet received any levodopa or dopamine agonists.

The efficacy parameter was based on a change from baseline (CFB) in patient UPDRS scores. There was a dose-ordered response, although the patients in the preladenant 2 mg twice daily arm actually worsened, showing a significant CFB of 0.30 and a 2.60 difference when compared with placebo (P = .0033; 95% confidence interval, 0.86-4.30).

The preladenant 5 mg twice-daily group improved, showing a –1.00 CFB and a 1.30 difference from placebo (P = .1382; 95% CI, –0.41-2.94). The preladenant 10 mg twice-daily arm also improved, showing a CFB of –1.80 with a difference of 0.40 from placebo (P = .6378; 95% CI, –1.29-2.11).

Patients in the 1 mg once-daily rasagiline group improved, but not significantly, with a CFB of -1.90 when compared with placebo (P = .6923; 95% CI, –1.35-2.03), however, the placebo arm had the best results overall with a CFB of –2.20.

"I should point out that rasagiline was our active comparator, and it was included to make sure that the trial worked," said Dr. Hauser. "The fact that [the rasagiline group] did not separate from placebo indicates that this was a failed trial."

Rasagiline is a monoamine oxidase type-B inhibitor, with Food and Drug Administration approval as both monotherapy in early Parkinson’s disease an as an adjunctive treatment in moderate to advanced Parkinson’s disease.

A post hoc analyses revealed that, across the sites, the strongest rasagiline response vs. placebo (when looking at the CFB on the UPDRS parts 2 and 3) occurred in the European Union (–2.4) and North America (–1.5). In Eastern Europe, placebo performed 4 points better than did rasagiline. In Latin America, the rasagiline and placebo arms showed parity. Dr. Hauser speculated that regional differences might reflect experience and expertise of sites in those regions that participated in the trial.

Preladenant previously had been found effective as an adjunct to levodopa when dosed at either 5 mg or 10 mg twice per day.

While it is not possible to draw definitive conclusions about preladenant’s efficacy as a monotherapy for Parkinson’s disease based on this trial, Dr. Hauser stated, "One of things I think this trial demonstrates is the value of having an active-control medication known to have efficacy in a situation when you are testing a new medication."

Dr. Hauser disclosed that he and his associates had many industry relationships, including his own with Abbott Laboratories, Allergan, AstraZeneca, Biotie Therapies, Ceregene, Chelsea Therapeutics, and GE Healthcare. This trial was underwritten by Merck.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Results of the phase III clinical trial to evaluate preladenant as monotherapy for Parkinson’s disease are difficult to interpret because the lack of observed efficacy of rasagiline as an active control indicates that the study didn’t work.

"There was not a significantly greater benefit in any of the arms, compared with placebo, including all the preladenant arms, and the rasagiline arm, our active-control medication with known efficacy," Dr. Robert A. Hauser revealed to a giggling crowd, some of whom applauded, at the annual meeting of the American Academy of Neurology.

"Interestingly enough, placebo was statistically superior to the lowest dose of preladenant," said Dr. Hauser, director of the Parkinson’s Disease and Movement Disorder Center at the University of South Florida, Tampa.

The randomized, double-blind, placebo- and active-controlled, parallel-group trial was designed to cover two 26-week time periods for a total of 52 weeks, and it was conducted at multiple centers in multiple countries. More than half (58%) of the 1,022 participants were men. The average age was 63 years, and the mean baseline score on the Unified Parkinson’s Disease Rating Scale (UPDRS) parts 2 and 3 was 28.5. The study participants had been diagnosed with Parkinson’s disease within the previous 5 years, and had not yet received any levodopa or dopamine agonists.

The efficacy parameter was based on a change from baseline (CFB) in patient UPDRS scores. There was a dose-ordered response, although the patients in the preladenant 2 mg twice daily arm actually worsened, showing a significant CFB of 0.30 and a 2.60 difference when compared with placebo (P = .0033; 95% confidence interval, 0.86-4.30).

The preladenant 5 mg twice-daily group improved, showing a –1.00 CFB and a 1.30 difference from placebo (P = .1382; 95% CI, –0.41-2.94). The preladenant 10 mg twice-daily arm also improved, showing a CFB of –1.80 with a difference of 0.40 from placebo (P = .6378; 95% CI, –1.29-2.11).

Patients in the 1 mg once-daily rasagiline group improved, but not significantly, with a CFB of -1.90 when compared with placebo (P = .6923; 95% CI, –1.35-2.03), however, the placebo arm had the best results overall with a CFB of –2.20.

"I should point out that rasagiline was our active comparator, and it was included to make sure that the trial worked," said Dr. Hauser. "The fact that [the rasagiline group] did not separate from placebo indicates that this was a failed trial."

Rasagiline is a monoamine oxidase type-B inhibitor, with Food and Drug Administration approval as both monotherapy in early Parkinson’s disease an as an adjunctive treatment in moderate to advanced Parkinson’s disease.

A post hoc analyses revealed that, across the sites, the strongest rasagiline response vs. placebo (when looking at the CFB on the UPDRS parts 2 and 3) occurred in the European Union (–2.4) and North America (–1.5). In Eastern Europe, placebo performed 4 points better than did rasagiline. In Latin America, the rasagiline and placebo arms showed parity. Dr. Hauser speculated that regional differences might reflect experience and expertise of sites in those regions that participated in the trial.

Preladenant previously had been found effective as an adjunct to levodopa when dosed at either 5 mg or 10 mg twice per day.

While it is not possible to draw definitive conclusions about preladenant’s efficacy as a monotherapy for Parkinson’s disease based on this trial, Dr. Hauser stated, "One of things I think this trial demonstrates is the value of having an active-control medication known to have efficacy in a situation when you are testing a new medication."

Dr. Hauser disclosed that he and his associates had many industry relationships, including his own with Abbott Laboratories, Allergan, AstraZeneca, Biotie Therapies, Ceregene, Chelsea Therapeutics, and GE Healthcare. This trial was underwritten by Merck.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Results of the phase III clinical trial to evaluate preladenant as monotherapy for Parkinson’s disease are difficult to interpret because the lack of observed efficacy of rasagiline as an active control indicates that the study didn’t work.

"There was not a significantly greater benefit in any of the arms, compared with placebo, including all the preladenant arms, and the rasagiline arm, our active-control medication with known efficacy," Dr. Robert A. Hauser revealed to a giggling crowd, some of whom applauded, at the annual meeting of the American Academy of Neurology.

"Interestingly enough, placebo was statistically superior to the lowest dose of preladenant," said Dr. Hauser, director of the Parkinson’s Disease and Movement Disorder Center at the University of South Florida, Tampa.

The randomized, double-blind, placebo- and active-controlled, parallel-group trial was designed to cover two 26-week time periods for a total of 52 weeks, and it was conducted at multiple centers in multiple countries. More than half (58%) of the 1,022 participants were men. The average age was 63 years, and the mean baseline score on the Unified Parkinson’s Disease Rating Scale (UPDRS) parts 2 and 3 was 28.5. The study participants had been diagnosed with Parkinson’s disease within the previous 5 years, and had not yet received any levodopa or dopamine agonists.

The efficacy parameter was based on a change from baseline (CFB) in patient UPDRS scores. There was a dose-ordered response, although the patients in the preladenant 2 mg twice daily arm actually worsened, showing a significant CFB of 0.30 and a 2.60 difference when compared with placebo (P = .0033; 95% confidence interval, 0.86-4.30).

The preladenant 5 mg twice-daily group improved, showing a –1.00 CFB and a 1.30 difference from placebo (P = .1382; 95% CI, –0.41-2.94). The preladenant 10 mg twice-daily arm also improved, showing a CFB of –1.80 with a difference of 0.40 from placebo (P = .6378; 95% CI, –1.29-2.11).

Patients in the 1 mg once-daily rasagiline group improved, but not significantly, with a CFB of -1.90 when compared with placebo (P = .6923; 95% CI, –1.35-2.03), however, the placebo arm had the best results overall with a CFB of –2.20.

"I should point out that rasagiline was our active comparator, and it was included to make sure that the trial worked," said Dr. Hauser. "The fact that [the rasagiline group] did not separate from placebo indicates that this was a failed trial."

Rasagiline is a monoamine oxidase type-B inhibitor, with Food and Drug Administration approval as both monotherapy in early Parkinson’s disease an as an adjunctive treatment in moderate to advanced Parkinson’s disease.

A post hoc analyses revealed that, across the sites, the strongest rasagiline response vs. placebo (when looking at the CFB on the UPDRS parts 2 and 3) occurred in the European Union (–2.4) and North America (–1.5). In Eastern Europe, placebo performed 4 points better than did rasagiline. In Latin America, the rasagiline and placebo arms showed parity. Dr. Hauser speculated that regional differences might reflect experience and expertise of sites in those regions that participated in the trial.

Preladenant previously had been found effective as an adjunct to levodopa when dosed at either 5 mg or 10 mg twice per day.

While it is not possible to draw definitive conclusions about preladenant’s efficacy as a monotherapy for Parkinson’s disease based on this trial, Dr. Hauser stated, "One of things I think this trial demonstrates is the value of having an active-control medication known to have efficacy in a situation when you are testing a new medication."

Dr. Hauser disclosed that he and his associates had many industry relationships, including his own with Abbott Laboratories, Allergan, AstraZeneca, Biotie Therapies, Ceregene, Chelsea Therapeutics, and GE Healthcare. This trial was underwritten by Merck.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Few templates exist for creating a pediatric oncofertility clinic, particularly in the context of the nascent trend of pediatric oncologists treating adults with pediatric cancers.

Dr. Karen Burns is a pediatric oncologist at Cincinnati Children’s Hospital who was part of the team that created that institution’s own oncofertility clinic. She offered tips to others who are interested in creating a similar clinic or who would like to incorporate protocols honoring ASCO’s recent position statement that all persons with cancer deserve the right to have fertility discussed as part of their standard of care.

In this audio interview, from the annual meeting of the North American Society for Pediatric and Adolescent Gynecology, Dr. Burns addresses the challenges of treating adults with pediatric cancers, having conversations about fertility with minors, the role of advance directives in oncofertility, and what burdens oncologists with patients in these situations face and how they can be eased by working with a team.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Few templates exist for creating a pediatric oncofertility clinic, particularly in the context of the nascent trend of pediatric oncologists treating adults with pediatric cancers.

Dr. Karen Burns is a pediatric oncologist at Cincinnati Children’s Hospital who was part of the team that created that institution’s own oncofertility clinic. She offered tips to others who are interested in creating a similar clinic or who would like to incorporate protocols honoring ASCO’s recent position statement that all persons with cancer deserve the right to have fertility discussed as part of their standard of care.

In this audio interview, from the annual meeting of the North American Society for Pediatric and Adolescent Gynecology, Dr. Burns addresses the challenges of treating adults with pediatric cancers, having conversations about fertility with minors, the role of advance directives in oncofertility, and what burdens oncologists with patients in these situations face and how they can be eased by working with a team.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Few templates exist for creating a pediatric oncofertility clinic, particularly in the context of the nascent trend of pediatric oncologists treating adults with pediatric cancers.

Dr. Karen Burns is a pediatric oncologist at Cincinnati Children’s Hospital who was part of the team that created that institution’s own oncofertility clinic. She offered tips to others who are interested in creating a similar clinic or who would like to incorporate protocols honoring ASCO’s recent position statement that all persons with cancer deserve the right to have fertility discussed as part of their standard of care.

In this audio interview, from the annual meeting of the North American Society for Pediatric and Adolescent Gynecology, Dr. Burns addresses the challenges of treating adults with pediatric cancers, having conversations about fertility with minors, the role of advance directives in oncofertility, and what burdens oncologists with patients in these situations face and how they can be eased by working with a team.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Even when parents believe that allowing their adolescent daughter to have a confidential gynecologic interview is to her benefit, they misunderstand the purpose and value of the interview at least half the time.

That’s according to Dr. Gylynthia Trotman, a second-year fellow at Medstar Washington Hospital Center, Children’s National Medical Center, Washington, who presented survey data on the topic during a poster session at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Dr. Trotman and her colleagues found that half of the 62 pairs of parents of adolescent girls aged 11-17 years who’d been seen in a gynecologic specialty clinic feared that if their child were to discuss her health concerns alone with the physician, then the parents would be excluded from the decision-making process.

"The majority of parents felt that this was inappropriate for their teen, because this was a specialized setting," Dr. Trotman said.

In this audio interview, Dr. Trotman explains what families misperceive about the confidential interview and why.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Even when parents believe that allowing their adolescent daughter to have a confidential gynecologic interview is to her benefit, they misunderstand the purpose and value of the interview at least half the time.

That’s according to Dr. Gylynthia Trotman, a second-year fellow at Medstar Washington Hospital Center, Children’s National Medical Center, Washington, who presented survey data on the topic during a poster session at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Dr. Trotman and her colleagues found that half of the 62 pairs of parents of adolescent girls aged 11-17 years who’d been seen in a gynecologic specialty clinic feared that if their child were to discuss her health concerns alone with the physician, then the parents would be excluded from the decision-making process.

"The majority of parents felt that this was inappropriate for their teen, because this was a specialized setting," Dr. Trotman said.

In this audio interview, Dr. Trotman explains what families misperceive about the confidential interview and why.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Even when parents believe that allowing their adolescent daughter to have a confidential gynecologic interview is to her benefit, they misunderstand the purpose and value of the interview at least half the time.

That’s according to Dr. Gylynthia Trotman, a second-year fellow at Medstar Washington Hospital Center, Children’s National Medical Center, Washington, who presented survey data on the topic during a poster session at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Dr. Trotman and her colleagues found that half of the 62 pairs of parents of adolescent girls aged 11-17 years who’d been seen in a gynecologic specialty clinic feared that if their child were to discuss her health concerns alone with the physician, then the parents would be excluded from the decision-making process.

"The majority of parents felt that this was inappropriate for their teen, because this was a specialized setting," Dr. Trotman said.

In this audio interview, Dr. Trotman explains what families misperceive about the confidential interview and why.

[email protected]

On Twitter @whitneymcknight

The Food and Drug Administration has approved Ragwitek, a sublingual treatment for short ragweed pollen–related allergic rhinitis in people aged 18-65 years.

This is the first FDA-approved oral therapy for hay fever, with or without conjunctivitis, and the third oral allergy medication approved by the FDA in less than a month. On April 1, the agency green-lighted Oralair for the treatment of gross pollen-related allergies in persons aged 10-65 years. On April 15, Grastek earned approval as an oral treatment for grass pollen allergy in people aged 5-65 years.

The approval offers "millions of adults living with ragweed-pollen allergies in the United States an alternative to allergy shots to help manage their disease," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. Other treatments include avoiding the allergen and medications to treat symptoms.

Ragwitek contains traces of pollen from the short ragweed (Ambrosia artemisiifolia) plant, and is administered as a quick-dissolving tablet placed once daily under the tongue. Treatment begins 12 weeks before the ragweed pollen season begins in late summer/early fall, and continues throughout the season. The first dose of the therapy is taken under observation by a health care provider. If no adverse reaction is noted after 30 minutes, the patient self-administers the medication thereafter.

Ragwitek’s safety was assessed in approximately 1,700 adults. The most common adverse reactions included itching in the mouth and ears and some throat irritation. Among those patients, 760 were evaluated to determine the therapy’s efficacy. Those assigned to Ragwitek reported about a 26% reduction in symptoms, compared with those who took placebo.

A black box warning accompanies the treatment, cautioning that life-threatening, severe allergic reactions are possible. A self-injected dose of epinephrine is recommended if needed.

Catalent Pharma Solutions manufactures Ragwitek for Merck, Sharp & Dohme.

[email protected]

On Twitter @whitneymcknight 

The Food and Drug Administration has approved Ragwitek, a sublingual treatment for short ragweed pollen–related allergic rhinitis in people aged 18-65 years.

This is the first FDA-approved oral therapy for hay fever, with or without conjunctivitis, and the third oral allergy medication approved by the FDA in less than a month. On April 1, the agency green-lighted Oralair for the treatment of gross pollen-related allergies in persons aged 10-65 years. On April 15, Grastek earned approval as an oral treatment for grass pollen allergy in people aged 5-65 years.

The approval offers "millions of adults living with ragweed-pollen allergies in the United States an alternative to allergy shots to help manage their disease," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. Other treatments include avoiding the allergen and medications to treat symptoms.

Ragwitek contains traces of pollen from the short ragweed (Ambrosia artemisiifolia) plant, and is administered as a quick-dissolving tablet placed once daily under the tongue. Treatment begins 12 weeks before the ragweed pollen season begins in late summer/early fall, and continues throughout the season. The first dose of the therapy is taken under observation by a health care provider. If no adverse reaction is noted after 30 minutes, the patient self-administers the medication thereafter.

Ragwitek’s safety was assessed in approximately 1,700 adults. The most common adverse reactions included itching in the mouth and ears and some throat irritation. Among those patients, 760 were evaluated to determine the therapy’s efficacy. Those assigned to Ragwitek reported about a 26% reduction in symptoms, compared with those who took placebo.

A black box warning accompanies the treatment, cautioning that life-threatening, severe allergic reactions are possible. A self-injected dose of epinephrine is recommended if needed.

Catalent Pharma Solutions manufactures Ragwitek for Merck, Sharp & Dohme.

[email protected]

On Twitter @whitneymcknight 

The Food and Drug Administration has approved Ragwitek, a sublingual treatment for short ragweed pollen–related allergic rhinitis in people aged 18-65 years.

This is the first FDA-approved oral therapy for hay fever, with or without conjunctivitis, and the third oral allergy medication approved by the FDA in less than a month. On April 1, the agency green-lighted Oralair for the treatment of gross pollen-related allergies in persons aged 10-65 years. On April 15, Grastek earned approval as an oral treatment for grass pollen allergy in people aged 5-65 years.

The approval offers "millions of adults living with ragweed-pollen allergies in the United States an alternative to allergy shots to help manage their disease," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. Other treatments include avoiding the allergen and medications to treat symptoms.

Ragwitek contains traces of pollen from the short ragweed (Ambrosia artemisiifolia) plant, and is administered as a quick-dissolving tablet placed once daily under the tongue. Treatment begins 12 weeks before the ragweed pollen season begins in late summer/early fall, and continues throughout the season. The first dose of the therapy is taken under observation by a health care provider. If no adverse reaction is noted after 30 minutes, the patient self-administers the medication thereafter.

Ragwitek’s safety was assessed in approximately 1,700 adults. The most common adverse reactions included itching in the mouth and ears and some throat irritation. Among those patients, 760 were evaluated to determine the therapy’s efficacy. Those assigned to Ragwitek reported about a 26% reduction in symptoms, compared with those who took placebo.

A black box warning accompanies the treatment, cautioning that life-threatening, severe allergic reactions are possible. A self-injected dose of epinephrine is recommended if needed.

Catalent Pharma Solutions manufactures Ragwitek for Merck, Sharp & Dohme.

[email protected]

On Twitter @whitneymcknight