Kate Johnson

Anorexia nervosa is a heritable psychiatric disorder with warning signs that can be identified decades before the onset of the illness, the largest twin study on the disorder shows.

“Genes play a substantial role in the development of this illness; there is a clear biological component,” said lead author Cynthia M. Bulik, Ph.D., in a teleconference about the new research (Arch. Gen. Psychiatry 2006;63:305–12).

The findings are good news for patients and their families, said Dr. Bulik, the William R. and Jeanne H. Jordan Distinguished Professor of Eating Disorders at the University of North Carolina, Chapel Hill.

“We have gone through too much time where parents have been blamed. Now families and patients can be liberated and empowered,” Dr. Bulik said. “This helps them understand they are fighting their biology.”

The study included 31,406 twins from the Swedish Twin Registry. The twins, born during 1935–1958, were sent a questionnaire in 1973 that assessed demographics, physical illnesses, physical activity level, personality, stress, and work exposures. Seven potential predictors of the development of anorexia nervosa (AN) were evaluated in the questionnaire, including body mass index, gastric problems, excessive exercise, perceived life stress, neuroticism, and extraversion. Zygosity information also was obtained.

The subjects were then interviewed in 1998–2002 at a median age of 54.6 years to establish who had gone on to develop AN, and to determine the predictors.

The study found that 1.2% of the females and 0.29% of the males met diagnostic criteria for a lifetime history of AN, a prevalence in line with other studies of the disorder. However, when the cohort was divided into those born in 1944 or earlier, and those born in 1945 or later, there was evidence of an increasing prevalence in women (0.65% prevalence in the older female cohort, compared with 1.56% in the younger group). Prevalence rates did not change for men.

Examining the incidence of AN as it related to zygosity, the researchers found a much higher concordance rate for AN among monozygotic twins than among dizygotic twins–signaling a clear genetic component, Dr. Bulik said. The analysis revealed that genetics accounted for 56% of an individual's risk of developing the disorder, unique environment accounted for 38%, and shared environment accounted for 5%.

This information is promising in the search for targeted prevention and medical treatments for AN, she said. “Research like this shows [AN] is not a sociocultural disorder. We need to look elsewhere. We need to look at genes.” She said other work in this field has identified several genes on chromosome 1 that might be involved in the development of AN and could be medication targets.

“I am perplexed and disappointed that we don't have medication for AN, and this is in part because we have not yet explained the biology adequately,” she said.

The study also found that of the potential predictors of AN assessed in the 1973 questionnaire, only neuroticism was predictive of the development of the disorder. The finding is notable because there have been few “truly prospective” risk-factor studies of AN, Dr. Bulik noted in the study. “What remains unknown is whether neuroticism is a nonspecific predictor of the development of psychopathology in general or whether it is specifically predictive of the emergence of AN.”

ELSEVIER GLOBAL MEDICAL NEWS

Anorexia nervosa is a heritable psychiatric disorder with warning signs that can be identified decades before the onset of the illness, the largest twin study on the disorder shows.

“Genes play a substantial role in the development of this illness; there is a clear biological component,” said lead author Cynthia M. Bulik, Ph.D., in a teleconference about the new research (Arch. Gen. Psychiatry 2006;63:305–12).

The findings are good news for patients and their families, said Dr. Bulik, the William R. and Jeanne H. Jordan Distinguished Professor of Eating Disorders at the University of North Carolina, Chapel Hill.

“We have gone through too much time where parents have been blamed. Now families and patients can be liberated and empowered,” Dr. Bulik said. “This helps them understand they are fighting their biology.”

The study included 31,406 twins from the Swedish Twin Registry. The twins, born during 1935–1958, were sent a questionnaire in 1973 that assessed demographics, physical illnesses, physical activity level, personality, stress, and work exposures. Seven potential predictors of the development of anorexia nervosa (AN) were evaluated in the questionnaire, including body mass index, gastric problems, excessive exercise, perceived life stress, neuroticism, and extraversion. Zygosity information also was obtained.

The subjects were then interviewed in 1998–2002 at a median age of 54.6 years to establish who had gone on to develop AN, and to determine the predictors.

The study found that 1.2% of the females and 0.29% of the males met diagnostic criteria for a lifetime history of AN, a prevalence in line with other studies of the disorder. However, when the cohort was divided into those born in 1944 or earlier, and those born in 1945 or later, there was evidence of an increasing prevalence in women (0.65% prevalence in the older female cohort, compared with 1.56% in the younger group). Prevalence rates did not change for men.

Examining the incidence of AN as it related to zygosity, the researchers found a much higher concordance rate for AN among monozygotic twins than among dizygotic twins–signaling a clear genetic component, Dr. Bulik said. The analysis revealed that genetics accounted for 56% of an individual's risk of developing the disorder, unique environment accounted for 38%, and shared environment accounted for 5%.

This information is promising in the search for targeted prevention and medical treatments for AN, she said. “Research like this shows [AN] is not a sociocultural disorder. We need to look elsewhere. We need to look at genes.” She said other work in this field has identified several genes on chromosome 1 that might be involved in the development of AN and could be medication targets.

“I am perplexed and disappointed that we don't have medication for AN, and this is in part because we have not yet explained the biology adequately,” she said.

The study also found that of the potential predictors of AN assessed in the 1973 questionnaire, only neuroticism was predictive of the development of the disorder. The finding is notable because there have been few “truly prospective” risk-factor studies of AN, Dr. Bulik noted in the study. “What remains unknown is whether neuroticism is a nonspecific predictor of the development of psychopathology in general or whether it is specifically predictive of the emergence of AN.”

ELSEVIER GLOBAL MEDICAL NEWS

Anorexia nervosa is a heritable psychiatric disorder with warning signs that can be identified decades before the onset of the illness, the largest twin study on the disorder shows.

“Genes play a substantial role in the development of this illness; there is a clear biological component,” said lead author Cynthia M. Bulik, Ph.D., in a teleconference about the new research (Arch. Gen. Psychiatry 2006;63:305–12).

The findings are good news for patients and their families, said Dr. Bulik, the William R. and Jeanne H. Jordan Distinguished Professor of Eating Disorders at the University of North Carolina, Chapel Hill.

“We have gone through too much time where parents have been blamed. Now families and patients can be liberated and empowered,” Dr. Bulik said. “This helps them understand they are fighting their biology.”

The study included 31,406 twins from the Swedish Twin Registry. The twins, born during 1935–1958, were sent a questionnaire in 1973 that assessed demographics, physical illnesses, physical activity level, personality, stress, and work exposures. Seven potential predictors of the development of anorexia nervosa (AN) were evaluated in the questionnaire, including body mass index, gastric problems, excessive exercise, perceived life stress, neuroticism, and extraversion. Zygosity information also was obtained.

The subjects were then interviewed in 1998–2002 at a median age of 54.6 years to establish who had gone on to develop AN, and to determine the predictors.

The study found that 1.2% of the females and 0.29% of the males met diagnostic criteria for a lifetime history of AN, a prevalence in line with other studies of the disorder. However, when the cohort was divided into those born in 1944 or earlier, and those born in 1945 or later, there was evidence of an increasing prevalence in women (0.65% prevalence in the older female cohort, compared with 1.56% in the younger group). Prevalence rates did not change for men.

Examining the incidence of AN as it related to zygosity, the researchers found a much higher concordance rate for AN among monozygotic twins than among dizygotic twins–signaling a clear genetic component, Dr. Bulik said. The analysis revealed that genetics accounted for 56% of an individual's risk of developing the disorder, unique environment accounted for 38%, and shared environment accounted for 5%.

This information is promising in the search for targeted prevention and medical treatments for AN, she said. “Research like this shows [AN] is not a sociocultural disorder. We need to look elsewhere. We need to look at genes.” She said other work in this field has identified several genes on chromosome 1 that might be involved in the development of AN and could be medication targets.

“I am perplexed and disappointed that we don't have medication for AN, and this is in part because we have not yet explained the biology adequately,” she said.

The study also found that of the potential predictors of AN assessed in the 1973 questionnaire, only neuroticism was predictive of the development of the disorder. The finding is notable because there have been few “truly prospective” risk-factor studies of AN, Dr. Bulik noted in the study. “What remains unknown is whether neuroticism is a nonspecific predictor of the development of psychopathology in general or whether it is specifically predictive of the emergence of AN.”

ELSEVIER GLOBAL MEDICAL NEWS

ORLANDO – Depression in elderly patients is easily missed by primary care physicians, according to a new study.

“Sometimes family doctors don't have time to screen for depression, and patients don't put it out on the table,” said Dr. Irene Mangani, who presented her findings in a poster at the annual meeting of the Gerontological Society of America.

“These people can be helped with a lot of interventions for depression, not just pharmacological interventions but also psychotherapy and exercise. And we miss these opportunities by not screening them for depression,” said Dr. Mangani, who is a geriatrician at the University of Florence, Italy. Her investigation included data from the ICARe Dicomano Study, which enrolled two waves of community-dwelling individuals, aged 65 years and older. The first group was enrolled in 1995, the second in 1999.

A total of 656 participants (mean age 74 years) completed the 30-item Geriatric Depression Scale (GDS), and their scores were compared with evaluations by primary care physicians who assessed the participants for depressive symptoms.

Using a GDS cutoff of 14 or higher to identify depression, the investigators found that the prevalence of depressive symptoms was 24% in the 1995 wave of participants and 31% in the 1999 wave. However, primary care physicians identified only a 14% prevalence in the first wave and 11% in the second wave.

“The GDS is not a diagnosis of depression. It is a screening tool that identifies depressive symptoms. But if someone has a GDS score higher than 14, they should be asked about other symptoms of depression because if they are depressed, this condition can be cured and can be dangerous if not taken care of,” Dr. Mangani said in an interview.

She said depression in this population has been linked with higher disability and mortality rates, making screening worthwhile, even in the primary care setting where there is so little time.

“Just asking a simple question like 'have you lost interest in things you usually like?' is something that doesn't take much time but can be important. If they answer yes, you can ask more questions or even give them the GDS screen,” she said.

ORLANDO – Depression in elderly patients is easily missed by primary care physicians, according to a new study.

“Sometimes family doctors don't have time to screen for depression, and patients don't put it out on the table,” said Dr. Irene Mangani, who presented her findings in a poster at the annual meeting of the Gerontological Society of America.

“These people can be helped with a lot of interventions for depression, not just pharmacological interventions but also psychotherapy and exercise. And we miss these opportunities by not screening them for depression,” said Dr. Mangani, who is a geriatrician at the University of Florence, Italy. Her investigation included data from the ICARe Dicomano Study, which enrolled two waves of community-dwelling individuals, aged 65 years and older. The first group was enrolled in 1995, the second in 1999.

A total of 656 participants (mean age 74 years) completed the 30-item Geriatric Depression Scale (GDS), and their scores were compared with evaluations by primary care physicians who assessed the participants for depressive symptoms.

Using a GDS cutoff of 14 or higher to identify depression, the investigators found that the prevalence of depressive symptoms was 24% in the 1995 wave of participants and 31% in the 1999 wave. However, primary care physicians identified only a 14% prevalence in the first wave and 11% in the second wave.

“The GDS is not a diagnosis of depression. It is a screening tool that identifies depressive symptoms. But if someone has a GDS score higher than 14, they should be asked about other symptoms of depression because if they are depressed, this condition can be cured and can be dangerous if not taken care of,” Dr. Mangani said in an interview.

She said depression in this population has been linked with higher disability and mortality rates, making screening worthwhile, even in the primary care setting where there is so little time.

“Just asking a simple question like 'have you lost interest in things you usually like?' is something that doesn't take much time but can be important. If they answer yes, you can ask more questions or even give them the GDS screen,” she said.

ORLANDO – Depression in elderly patients is easily missed by primary care physicians, according to a new study.

“Sometimes family doctors don't have time to screen for depression, and patients don't put it out on the table,” said Dr. Irene Mangani, who presented her findings in a poster at the annual meeting of the Gerontological Society of America.

“These people can be helped with a lot of interventions for depression, not just pharmacological interventions but also psychotherapy and exercise. And we miss these opportunities by not screening them for depression,” said Dr. Mangani, who is a geriatrician at the University of Florence, Italy. Her investigation included data from the ICARe Dicomano Study, which enrolled two waves of community-dwelling individuals, aged 65 years and older. The first group was enrolled in 1995, the second in 1999.

A total of 656 participants (mean age 74 years) completed the 30-item Geriatric Depression Scale (GDS), and their scores were compared with evaluations by primary care physicians who assessed the participants for depressive symptoms.

Using a GDS cutoff of 14 or higher to identify depression, the investigators found that the prevalence of depressive symptoms was 24% in the 1995 wave of participants and 31% in the 1999 wave. However, primary care physicians identified only a 14% prevalence in the first wave and 11% in the second wave.

“The GDS is not a diagnosis of depression. It is a screening tool that identifies depressive symptoms. But if someone has a GDS score higher than 14, they should be asked about other symptoms of depression because if they are depressed, this condition can be cured and can be dangerous if not taken care of,” Dr. Mangani said in an interview.

She said depression in this population has been linked with higher disability and mortality rates, making screening worthwhile, even in the primary care setting where there is so little time.

“Just asking a simple question like 'have you lost interest in things you usually like?' is something that doesn't take much time but can be important. If they answer yes, you can ask more questions or even give them the GDS screen,” she said.

ORLANDO – Dementia patients who have taken atypical and conventional antipsychotic medications have more adverse events than do patients with a history of only one medication, new research shows.

“It's hard to say there is a strong causal connection, but there is an association, and it gives physicians something to think about when they are prescribing–and perhaps overprescribing–drugs for dementia,” said Frank M. Ahern, Ph.D., one of the authors of the study, which was presented as a poster at the annual meeting of the Gerontological Society of America.

“These individuals are likely to be those whose behaviors do not respond to initial pharmacological therapy,” added the lead author, Ann Kolanowski, Ph.D., of the Pennsylvania State University in University Park.

Up to 90% of people with dementia (PWD) exhibit behavioral and psychological symptoms of dementia (BPSD) that can be controlled with antipsychotic medications. But although the newer atypical antipsychotics seem to have a better side-effect profile, little is known about how these drugs are used in community-dwelling PWD, said Dr. Ahern, professor of biobehavioral health at the university.

The retrospective study used the database of a managed care organization to identify 3,231 community-dwelling PWD who had at least one claim in the preceding 3 years.

A total of 260 (8%) had taken antipsychotic drugs, with most of this group (62%) having taken atypical medication. The remaining patients had taken either conventional medication (24%) or both (14%) during that time period.

In comparing this prescription information with claims data, the researchers found that not only was the use of any antipsychotic medication associated with more adverse events than no use, but that generally, atypical antipsychotics were associated with more problems than conventional antipsychotics. Patients who had a history of taking both types of medication over the study period had the most problems.

“More often than not, it looks like combination therapy–which really means more drugs–might be more risky,” said Dr. Ahern in an interview.

Combination therapy refers to the use of both types of drugs, but not necessarily at the same time, during the 3-year study period, Dr. Kolanowski said. “Because the data were taken from an administrative database, we had no way of determining whether these two different types of medication were actually taken together,” she said in an interview.

Specifically, compared with no medication use, the use of both types of medication had the highest risk for delirium (odds ratio 3.6), followed by atypical medications alone (OR 1.5). There was a reduced risk associated with conventional medication alone (OR 0.8).

Similarly, the use of both medication types carried more risk for depression (OR 3.6), compared with atypical medications alone (OR 2.73).

For falls, the use of both types of medication again carried the highest risk (OR 2.8), with similar risks for conventional therapy alone (OR 2.2), and atypicals alone (OR 2.1).

For femur fracture, a history of both types of medication had the highest risk (OR 3.7), followed by atypicals alone (OR 2.5), and conventional medications alone (OR 1.6).

And finally, for syncope, use of both medication types increased the risk (OR 2.8) while either medication alone decreased it.

ORLANDO – Dementia patients who have taken atypical and conventional antipsychotic medications have more adverse events than do patients with a history of only one medication, new research shows.

“It's hard to say there is a strong causal connection, but there is an association, and it gives physicians something to think about when they are prescribing–and perhaps overprescribing–drugs for dementia,” said Frank M. Ahern, Ph.D., one of the authors of the study, which was presented as a poster at the annual meeting of the Gerontological Society of America.

“These individuals are likely to be those whose behaviors do not respond to initial pharmacological therapy,” added the lead author, Ann Kolanowski, Ph.D., of the Pennsylvania State University in University Park.

Up to 90% of people with dementia (PWD) exhibit behavioral and psychological symptoms of dementia (BPSD) that can be controlled with antipsychotic medications. But although the newer atypical antipsychotics seem to have a better side-effect profile, little is known about how these drugs are used in community-dwelling PWD, said Dr. Ahern, professor of biobehavioral health at the university.

The retrospective study used the database of a managed care organization to identify 3,231 community-dwelling PWD who had at least one claim in the preceding 3 years.

A total of 260 (8%) had taken antipsychotic drugs, with most of this group (62%) having taken atypical medication. The remaining patients had taken either conventional medication (24%) or both (14%) during that time period.

In comparing this prescription information with claims data, the researchers found that not only was the use of any antipsychotic medication associated with more adverse events than no use, but that generally, atypical antipsychotics were associated with more problems than conventional antipsychotics. Patients who had a history of taking both types of medication over the study period had the most problems.

“More often than not, it looks like combination therapy–which really means more drugs–might be more risky,” said Dr. Ahern in an interview.

Combination therapy refers to the use of both types of drugs, but not necessarily at the same time, during the 3-year study period, Dr. Kolanowski said. “Because the data were taken from an administrative database, we had no way of determining whether these two different types of medication were actually taken together,” she said in an interview.

Specifically, compared with no medication use, the use of both types of medication had the highest risk for delirium (odds ratio 3.6), followed by atypical medications alone (OR 1.5). There was a reduced risk associated with conventional medication alone (OR 0.8).

Similarly, the use of both medication types carried more risk for depression (OR 3.6), compared with atypical medications alone (OR 2.73).

For falls, the use of both types of medication again carried the highest risk (OR 2.8), with similar risks for conventional therapy alone (OR 2.2), and atypicals alone (OR 2.1).

For femur fracture, a history of both types of medication had the highest risk (OR 3.7), followed by atypicals alone (OR 2.5), and conventional medications alone (OR 1.6).

And finally, for syncope, use of both medication types increased the risk (OR 2.8) while either medication alone decreased it.

ORLANDO – Dementia patients who have taken atypical and conventional antipsychotic medications have more adverse events than do patients with a history of only one medication, new research shows.

“It's hard to say there is a strong causal connection, but there is an association, and it gives physicians something to think about when they are prescribing–and perhaps overprescribing–drugs for dementia,” said Frank M. Ahern, Ph.D., one of the authors of the study, which was presented as a poster at the annual meeting of the Gerontological Society of America.

“These individuals are likely to be those whose behaviors do not respond to initial pharmacological therapy,” added the lead author, Ann Kolanowski, Ph.D., of the Pennsylvania State University in University Park.

Up to 90% of people with dementia (PWD) exhibit behavioral and psychological symptoms of dementia (BPSD) that can be controlled with antipsychotic medications. But although the newer atypical antipsychotics seem to have a better side-effect profile, little is known about how these drugs are used in community-dwelling PWD, said Dr. Ahern, professor of biobehavioral health at the university.

The retrospective study used the database of a managed care organization to identify 3,231 community-dwelling PWD who had at least one claim in the preceding 3 years.

A total of 260 (8%) had taken antipsychotic drugs, with most of this group (62%) having taken atypical medication. The remaining patients had taken either conventional medication (24%) or both (14%) during that time period.

In comparing this prescription information with claims data, the researchers found that not only was the use of any antipsychotic medication associated with more adverse events than no use, but that generally, atypical antipsychotics were associated with more problems than conventional antipsychotics. Patients who had a history of taking both types of medication over the study period had the most problems.

“More often than not, it looks like combination therapy–which really means more drugs–might be more risky,” said Dr. Ahern in an interview.

Combination therapy refers to the use of both types of drugs, but not necessarily at the same time, during the 3-year study period, Dr. Kolanowski said. “Because the data were taken from an administrative database, we had no way of determining whether these two different types of medication were actually taken together,” she said in an interview.

Specifically, compared with no medication use, the use of both types of medication had the highest risk for delirium (odds ratio 3.6), followed by atypical medications alone (OR 1.5). There was a reduced risk associated with conventional medication alone (OR 0.8).

Similarly, the use of both medication types carried more risk for depression (OR 3.6), compared with atypical medications alone (OR 2.73).

For falls, the use of both types of medication again carried the highest risk (OR 2.8), with similar risks for conventional therapy alone (OR 2.2), and atypicals alone (OR 2.1).

For femur fracture, a history of both types of medication had the highest risk (OR 3.7), followed by atypicals alone (OR 2.5), and conventional medications alone (OR 1.6).

And finally, for syncope, use of both medication types increased the risk (OR 2.8) while either medication alone decreased it.

The dwindling supply of varicella-zoster immune globulin in the United States has been replenished with a new unlicensed product that has been made available under a Food and Drug Administration investigational new drug application, according to the Centers for Disease Control and Prevention.

An expanded access protocol for VariZIG (Cangene Corporation, Winnipeg, Manitoba) was granted in February as supplies of the only licensed U.S. varicella-zoster immune globulin (VZIG) product began to run out, following its discontinuation last October by the manufacturer, Public Health Biologic Laboratories of Boston.

VariZIG is intended for patients without evidence of immunity who have been exposed to varicella and who are at increased risk for severe disease and complications. The CDC's Advisory Committee on Immunization Practices recommends it for these groups:

▸ Immunocompromised patients.

▸ Pregnant women.

▸ Neonates whose mothers have signs and symptoms of varicella around the time of delivery (5 days before to 2 days after).

▸ Premature infants who are born at or after 28 weeks of gestation, who are exposed during the neonatal period, and whose mothers do not have evidence of immunity.

▸ Premature infants who are born before 28 weeks of gestation, or who weigh 1,000 g or more at birth and were exposed during the neonatal period, regardless of maternal history of varicella disease or vaccination.

The Canadian product is expected to provide maximum benefit when it is administered as soon as possible after exposure, although it would still be considered likely to be effective if it was administered up to 96 hours following exposure (MMWR 2006;55[early release]:www.cdc.gov/mmwr

For other patients who are not included in the above groups and without evidence of immunity, the varicella vaccine is recommended for prophylaxis within 96 hours and possibly up to a maximum of 120 hours post exposure, according to the report.

The CDC recommends that health care providers “should make every effort to obtain and administer VariZIG” when indicated.

The product can be requested from the sole authorized U.S. distributor, FFF Enterprises (Temecula, Calif.), through its 24-hour telephone line, 800-843-7477.

The expanded access protocol received central institutional review board approval, meaning that the FDA does not require additional institutional review board approval at individual institutions, according to the CDC.

Pharmacists and health care providers who anticipate needing the product can acquire inventory in advance.

As with any product used under an investigational new drug application, patients must be informed of the investigational drug's potential risks and benefits and must give their informed consent before using it.

Patients receiving the therapy should be observed closely for 28 days after exposure for signs and symptoms of varicella (VariZIG might prolong the incubation period by 1 week or more) and treated with acyclovir antiviral therapy if necessary.

When varicella vaccine is not contraindicated, patients receiving VariZIG should be subsequently vaccinated but only after a delay of 5 months, according to the CDC report.

Vaccination is not necessary if the patient contracts varicella after receiving VariZIG.

If VariZIG is not available within 96 hours of exposure, a single dose of immune globulin intravenous should be considered as an alternative, at a recommended dose of 400 mg/kg, administered once.

The dwindling supply of varicella-zoster immune globulin in the United States has been replenished with a new unlicensed product that has been made available under a Food and Drug Administration investigational new drug application, according to the Centers for Disease Control and Prevention.

An expanded access protocol for VariZIG (Cangene Corporation, Winnipeg, Manitoba) was granted in February as supplies of the only licensed U.S. varicella-zoster immune globulin (VZIG) product began to run out, following its discontinuation last October by the manufacturer, Public Health Biologic Laboratories of Boston.

VariZIG is intended for patients without evidence of immunity who have been exposed to varicella and who are at increased risk for severe disease and complications. The CDC's Advisory Committee on Immunization Practices recommends it for these groups:

▸ Immunocompromised patients.

▸ Pregnant women.

▸ Neonates whose mothers have signs and symptoms of varicella around the time of delivery (5 days before to 2 days after).

▸ Premature infants who are born at or after 28 weeks of gestation, who are exposed during the neonatal period, and whose mothers do not have evidence of immunity.

▸ Premature infants who are born before 28 weeks of gestation, or who weigh 1,000 g or more at birth and were exposed during the neonatal period, regardless of maternal history of varicella disease or vaccination.

The Canadian product is expected to provide maximum benefit when it is administered as soon as possible after exposure, although it would still be considered likely to be effective if it was administered up to 96 hours following exposure (MMWR 2006;55[early release]:www.cdc.gov/mmwr

For other patients who are not included in the above groups and without evidence of immunity, the varicella vaccine is recommended for prophylaxis within 96 hours and possibly up to a maximum of 120 hours post exposure, according to the report.

The CDC recommends that health care providers “should make every effort to obtain and administer VariZIG” when indicated.

The product can be requested from the sole authorized U.S. distributor, FFF Enterprises (Temecula, Calif.), through its 24-hour telephone line, 800-843-7477.

The expanded access protocol received central institutional review board approval, meaning that the FDA does not require additional institutional review board approval at individual institutions, according to the CDC.

Pharmacists and health care providers who anticipate needing the product can acquire inventory in advance.

As with any product used under an investigational new drug application, patients must be informed of the investigational drug's potential risks and benefits and must give their informed consent before using it.

Patients receiving the therapy should be observed closely for 28 days after exposure for signs and symptoms of varicella (VariZIG might prolong the incubation period by 1 week or more) and treated with acyclovir antiviral therapy if necessary.

When varicella vaccine is not contraindicated, patients receiving VariZIG should be subsequently vaccinated but only after a delay of 5 months, according to the CDC report.

Vaccination is not necessary if the patient contracts varicella after receiving VariZIG.

If VariZIG is not available within 96 hours of exposure, a single dose of immune globulin intravenous should be considered as an alternative, at a recommended dose of 400 mg/kg, administered once.

The dwindling supply of varicella-zoster immune globulin in the United States has been replenished with a new unlicensed product that has been made available under a Food and Drug Administration investigational new drug application, according to the Centers for Disease Control and Prevention.

An expanded access protocol for VariZIG (Cangene Corporation, Winnipeg, Manitoba) was granted in February as supplies of the only licensed U.S. varicella-zoster immune globulin (VZIG) product began to run out, following its discontinuation last October by the manufacturer, Public Health Biologic Laboratories of Boston.

VariZIG is intended for patients without evidence of immunity who have been exposed to varicella and who are at increased risk for severe disease and complications. The CDC's Advisory Committee on Immunization Practices recommends it for these groups:

▸ Immunocompromised patients.

▸ Pregnant women.

▸ Neonates whose mothers have signs and symptoms of varicella around the time of delivery (5 days before to 2 days after).

▸ Premature infants who are born at or after 28 weeks of gestation, who are exposed during the neonatal period, and whose mothers do not have evidence of immunity.

▸ Premature infants who are born before 28 weeks of gestation, or who weigh 1,000 g or more at birth and were exposed during the neonatal period, regardless of maternal history of varicella disease or vaccination.

The Canadian product is expected to provide maximum benefit when it is administered as soon as possible after exposure, although it would still be considered likely to be effective if it was administered up to 96 hours following exposure (MMWR 2006;55[early release]:www.cdc.gov/mmwr

For other patients who are not included in the above groups and without evidence of immunity, the varicella vaccine is recommended for prophylaxis within 96 hours and possibly up to a maximum of 120 hours post exposure, according to the report.

The CDC recommends that health care providers “should make every effort to obtain and administer VariZIG” when indicated.

The product can be requested from the sole authorized U.S. distributor, FFF Enterprises (Temecula, Calif.), through its 24-hour telephone line, 800-843-7477.

The expanded access protocol received central institutional review board approval, meaning that the FDA does not require additional institutional review board approval at individual institutions, according to the CDC.

Pharmacists and health care providers who anticipate needing the product can acquire inventory in advance.

As with any product used under an investigational new drug application, patients must be informed of the investigational drug's potential risks and benefits and must give their informed consent before using it.

Patients receiving the therapy should be observed closely for 28 days after exposure for signs and symptoms of varicella (VariZIG might prolong the incubation period by 1 week or more) and treated with acyclovir antiviral therapy if necessary.

When varicella vaccine is not contraindicated, patients receiving VariZIG should be subsequently vaccinated but only after a delay of 5 months, according to the CDC report.

Vaccination is not necessary if the patient contracts varicella after receiving VariZIG.

If VariZIG is not available within 96 hours of exposure, a single dose of immune globulin intravenous should be considered as an alternative, at a recommended dose of 400 mg/kg, administered once.

Elderly women, particularly those who are less active, can significantly reduce their risk of falling by taking a daily supplement of vitamin D, according to a new study. However, the supplement does not protect men in the same age group.

Daily supplementation with 700 IU of cholecalciferol and 500 mg of calcium citrate malate reduced the odds of falling by 46% in ambulatory older women and by 65% in less active women, noted Dr. Heike A. Bischoff-Ferrari of University Hospital Zurich, and colleagues.

The supplementation is not only “very inexpensive, well tolerated, and simple” but also has similar or greater benefit than more expensive and time-intensive interventions, added the authors (Arch. Intern. Med. 2006;166:424–30).

The findings are from a secondary analysis of a 3-year double-blind placebo-controlled study that looked at the effect of cholecalciferol-calcium on bone mineral density. Primary results of the study noted a 60% reduction of osteoporotic fractures with the supplement, compared with placebo. The secondary analysis examined the risk of falling during the study period for 199 men and 246 women aged 65 years or older.

Multivariate analysis controlled for age, gender, baseline body mass index, dietary calcium, baseline plasma 25-hydroxyvitamin D (25-OHD) levels, baseline plasma intact parathyroid hormone levels, activity level, baseline smoking status, baseline alcohol use, baseline comorbid conditions, baseline creatinine clearance and length of follow-up.

Overall, cholecalciferol-calcium supplementation did not significantly reduce the risk of falling compared with placebo, with 49% of men and 55% of women reporting at least one fall during the study period. However, multivariate analysis revealed that, compared with placebo, supplementation significantly reduced the odds of falling in women (odds ratio [OR] 0.54) and particularly in less active women (OR 0.35).

The treatment did not have the same effect on men, however, regardless of whether they were less active (OR 0.96) or more active (OR 1.01).

Baseline levels of 25-OHD, creatinine clearance or parathyroid hormone did not impact the effect of the supplement.

The gender difference in the effect of vitamin D supplementation has not been previously described because generally men have not been included in previous studies, noted the authors. One explanation for this gender difference in treatment effect could be that decreased muscle strength in women, compared with men, makes them more susceptible to falls, the investigators suggested. Vitamin D supplementation increases muscle strength thus protecting against falls.

They noted that length of treatment was another important factor in the study because the benefit of supplementation “increased with time and occurred primarily after 12 months of treatment.” Short-term benefits of supplementation have been noted in other studies, but “may be explained by a combination of older age, increased frailty, and significantly lower baseline 25-OHD levels in their participants,” they observed.

The fact that low baseline levels of 25-OHD did not enhance treatment effects in this study “may be explained by the rather high mean baseline 25-OHD levels observed in our study participants, which is likely owing to vitamin D fortification in dairy products and activity level of our healthy and relatively young community-dwelling older participants,” the investigators noted.

Elderly women, particularly those who are less active, can significantly reduce their risk of falling by taking a daily supplement of vitamin D, according to a new study. However, the supplement does not protect men in the same age group.

Daily supplementation with 700 IU of cholecalciferol and 500 mg of calcium citrate malate reduced the odds of falling by 46% in ambulatory older women and by 65% in less active women, noted Dr. Heike A. Bischoff-Ferrari of University Hospital Zurich, and colleagues.

The supplementation is not only “very inexpensive, well tolerated, and simple” but also has similar or greater benefit than more expensive and time-intensive interventions, added the authors (Arch. Intern. Med. 2006;166:424–30).

The findings are from a secondary analysis of a 3-year double-blind placebo-controlled study that looked at the effect of cholecalciferol-calcium on bone mineral density. Primary results of the study noted a 60% reduction of osteoporotic fractures with the supplement, compared with placebo. The secondary analysis examined the risk of falling during the study period for 199 men and 246 women aged 65 years or older.

Multivariate analysis controlled for age, gender, baseline body mass index, dietary calcium, baseline plasma 25-hydroxyvitamin D (25-OHD) levels, baseline plasma intact parathyroid hormone levels, activity level, baseline smoking status, baseline alcohol use, baseline comorbid conditions, baseline creatinine clearance and length of follow-up.

Overall, cholecalciferol-calcium supplementation did not significantly reduce the risk of falling compared with placebo, with 49% of men and 55% of women reporting at least one fall during the study period. However, multivariate analysis revealed that, compared with placebo, supplementation significantly reduced the odds of falling in women (odds ratio [OR] 0.54) and particularly in less active women (OR 0.35).

The treatment did not have the same effect on men, however, regardless of whether they were less active (OR 0.96) or more active (OR 1.01).

Baseline levels of 25-OHD, creatinine clearance or parathyroid hormone did not impact the effect of the supplement.

The gender difference in the effect of vitamin D supplementation has not been previously described because generally men have not been included in previous studies, noted the authors. One explanation for this gender difference in treatment effect could be that decreased muscle strength in women, compared with men, makes them more susceptible to falls, the investigators suggested. Vitamin D supplementation increases muscle strength thus protecting against falls.

They noted that length of treatment was another important factor in the study because the benefit of supplementation “increased with time and occurred primarily after 12 months of treatment.” Short-term benefits of supplementation have been noted in other studies, but “may be explained by a combination of older age, increased frailty, and significantly lower baseline 25-OHD levels in their participants,” they observed.

The fact that low baseline levels of 25-OHD did not enhance treatment effects in this study “may be explained by the rather high mean baseline 25-OHD levels observed in our study participants, which is likely owing to vitamin D fortification in dairy products and activity level of our healthy and relatively young community-dwelling older participants,” the investigators noted.

Elderly women, particularly those who are less active, can significantly reduce their risk of falling by taking a daily supplement of vitamin D, according to a new study. However, the supplement does not protect men in the same age group.

Daily supplementation with 700 IU of cholecalciferol and 500 mg of calcium citrate malate reduced the odds of falling by 46% in ambulatory older women and by 65% in less active women, noted Dr. Heike A. Bischoff-Ferrari of University Hospital Zurich, and colleagues.

The supplementation is not only “very inexpensive, well tolerated, and simple” but also has similar or greater benefit than more expensive and time-intensive interventions, added the authors (Arch. Intern. Med. 2006;166:424–30).

The findings are from a secondary analysis of a 3-year double-blind placebo-controlled study that looked at the effect of cholecalciferol-calcium on bone mineral density. Primary results of the study noted a 60% reduction of osteoporotic fractures with the supplement, compared with placebo. The secondary analysis examined the risk of falling during the study period for 199 men and 246 women aged 65 years or older.

Multivariate analysis controlled for age, gender, baseline body mass index, dietary calcium, baseline plasma 25-hydroxyvitamin D (25-OHD) levels, baseline plasma intact parathyroid hormone levels, activity level, baseline smoking status, baseline alcohol use, baseline comorbid conditions, baseline creatinine clearance and length of follow-up.

Overall, cholecalciferol-calcium supplementation did not significantly reduce the risk of falling compared with placebo, with 49% of men and 55% of women reporting at least one fall during the study period. However, multivariate analysis revealed that, compared with placebo, supplementation significantly reduced the odds of falling in women (odds ratio [OR] 0.54) and particularly in less active women (OR 0.35).

The treatment did not have the same effect on men, however, regardless of whether they were less active (OR 0.96) or more active (OR 1.01).

Baseline levels of 25-OHD, creatinine clearance or parathyroid hormone did not impact the effect of the supplement.

The gender difference in the effect of vitamin D supplementation has not been previously described because generally men have not been included in previous studies, noted the authors. One explanation for this gender difference in treatment effect could be that decreased muscle strength in women, compared with men, makes them more susceptible to falls, the investigators suggested. Vitamin D supplementation increases muscle strength thus protecting against falls.

They noted that length of treatment was another important factor in the study because the benefit of supplementation “increased with time and occurred primarily after 12 months of treatment.” Short-term benefits of supplementation have been noted in other studies, but “may be explained by a combination of older age, increased frailty, and significantly lower baseline 25-OHD levels in their participants,” they observed.

The fact that low baseline levels of 25-OHD did not enhance treatment effects in this study “may be explained by the rather high mean baseline 25-OHD levels observed in our study participants, which is likely owing to vitamin D fortification in dairy products and activity level of our healthy and relatively young community-dwelling older participants,” the investigators noted.

The spread of avian influenza to poultry in Niger confirms officials' fears that conditions in West Africa favor further spread of the infection, the World Health Organization has reported.

There are currently no human cases of H5N1 viral infection confirmed in Africa. In Nigeria, local tests have ruled out avian influenza in three of four people with respiratory illnesses, one of which was fatal.

Concern about the potential for human infection remains high, the World Health Organization (WHO) said in a statement. “The WHO is concerned that spread of the virus to additional parts of Africa will broaden opportunities for human cases to occur under circumstances where capacities to find, diagnose, investigate, and manage cases are limited,” the organization said.

Poultry outbreaks in “numerous” other African countries are under investigation, but “throughout most of Africa, rapid detection and investigation of outbreaks are hampered by the absence of an early warning system for avian influenza in animals or humans, inadequate diagnostic capacity, and difficulties in shipping specimens, both internally and abroad, for diagnostic confirmation,” the WHO said.

In addition, economic concerns are mounting. “Backyard producers in many developing countries are losing income and are facing increased livelihood and food security risks,” the Food and Agriculture Organization (FAO) of the United Nations reported. Globally, more than 200 million chickens have been culled since the onset of the avian influenza crisis, it said in a statement.

The WHO stressed that despite a rapid increase in disease activity among birds and the infection of 174 people (including 94 deaths), proper cooking of poultry products kills the virus. No human cases have been “linked to the consumption of properly cooked poultry or poultry products,” the statement said. The FAO confirmed that poultry products cooked at or above 70°C are safe.

Meanwhile, as Sweden joined the list of European countries confirming H5N1 infection in wild birds, German authorities announced the detection of the virus in a dead domestic cat from the island of Ruegen, where the infection has already been confirmed in wild birds. The cat's infection marks the first evidence of avian influenza in a European mammal, but “there is no present evidence that domestic cats play a role in the transmission,” said the WHO. “All available evidence indicates that cat infections occur in association with H5N1 outbreaks in domestic or wild birds.”

Since 2003 there have been anecdotal reports from Southeast Asia of domestic cat infections with the H5N1 virus. Eating raw infected poultry was the most likely source of those infections, said the WHO.

The spread of avian influenza to poultry in Niger confirms officials' fears that conditions in West Africa favor further spread of the infection, the World Health Organization has reported.

There are currently no human cases of H5N1 viral infection confirmed in Africa. In Nigeria, local tests have ruled out avian influenza in three of four people with respiratory illnesses, one of which was fatal.

Concern about the potential for human infection remains high, the World Health Organization (WHO) said in a statement. “The WHO is concerned that spread of the virus to additional parts of Africa will broaden opportunities for human cases to occur under circumstances where capacities to find, diagnose, investigate, and manage cases are limited,” the organization said.

Poultry outbreaks in “numerous” other African countries are under investigation, but “throughout most of Africa, rapid detection and investigation of outbreaks are hampered by the absence of an early warning system for avian influenza in animals or humans, inadequate diagnostic capacity, and difficulties in shipping specimens, both internally and abroad, for diagnostic confirmation,” the WHO said.

In addition, economic concerns are mounting. “Backyard producers in many developing countries are losing income and are facing increased livelihood and food security risks,” the Food and Agriculture Organization (FAO) of the United Nations reported. Globally, more than 200 million chickens have been culled since the onset of the avian influenza crisis, it said in a statement.

The WHO stressed that despite a rapid increase in disease activity among birds and the infection of 174 people (including 94 deaths), proper cooking of poultry products kills the virus. No human cases have been “linked to the consumption of properly cooked poultry or poultry products,” the statement said. The FAO confirmed that poultry products cooked at or above 70°C are safe.

Meanwhile, as Sweden joined the list of European countries confirming H5N1 infection in wild birds, German authorities announced the detection of the virus in a dead domestic cat from the island of Ruegen, where the infection has already been confirmed in wild birds. The cat's infection marks the first evidence of avian influenza in a European mammal, but “there is no present evidence that domestic cats play a role in the transmission,” said the WHO. “All available evidence indicates that cat infections occur in association with H5N1 outbreaks in domestic or wild birds.”

Since 2003 there have been anecdotal reports from Southeast Asia of domestic cat infections with the H5N1 virus. Eating raw infected poultry was the most likely source of those infections, said the WHO.

The spread of avian influenza to poultry in Niger confirms officials' fears that conditions in West Africa favor further spread of the infection, the World Health Organization has reported.

There are currently no human cases of H5N1 viral infection confirmed in Africa. In Nigeria, local tests have ruled out avian influenza in three of four people with respiratory illnesses, one of which was fatal.

Concern about the potential for human infection remains high, the World Health Organization (WHO) said in a statement. “The WHO is concerned that spread of the virus to additional parts of Africa will broaden opportunities for human cases to occur under circumstances where capacities to find, diagnose, investigate, and manage cases are limited,” the organization said.

Poultry outbreaks in “numerous” other African countries are under investigation, but “throughout most of Africa, rapid detection and investigation of outbreaks are hampered by the absence of an early warning system for avian influenza in animals or humans, inadequate diagnostic capacity, and difficulties in shipping specimens, both internally and abroad, for diagnostic confirmation,” the WHO said.

In addition, economic concerns are mounting. “Backyard producers in many developing countries are losing income and are facing increased livelihood and food security risks,” the Food and Agriculture Organization (FAO) of the United Nations reported. Globally, more than 200 million chickens have been culled since the onset of the avian influenza crisis, it said in a statement.

The WHO stressed that despite a rapid increase in disease activity among birds and the infection of 174 people (including 94 deaths), proper cooking of poultry products kills the virus. No human cases have been “linked to the consumption of properly cooked poultry or poultry products,” the statement said. The FAO confirmed that poultry products cooked at or above 70°C are safe.

Meanwhile, as Sweden joined the list of European countries confirming H5N1 infection in wild birds, German authorities announced the detection of the virus in a dead domestic cat from the island of Ruegen, where the infection has already been confirmed in wild birds. The cat's infection marks the first evidence of avian influenza in a European mammal, but “there is no present evidence that domestic cats play a role in the transmission,” said the WHO. “All available evidence indicates that cat infections occur in association with H5N1 outbreaks in domestic or wild birds.”

Since 2003 there have been anecdotal reports from Southeast Asia of domestic cat infections with the H5N1 virus. Eating raw infected poultry was the most likely source of those infections, said the WHO.

The dwindling U.S. supply of varicella-zoster immune globulin has been replenished with a new unlicensed product made available under a Food and Drug Administration investigational new drug application, according to the Centers for Disease Control and Prevention.

An expanded access protocol for VariZIG (Cangene Corporation, Winnipeg, Canada) was granted in February as supplies of the only licensed U.S. varicella-zoster immune globulin (VZIG) product began to run out, following its discontinuation last October by the manufacturer, Public Health Biologic Laboratories of Boston.

VariZIG is intended for patients without evidence of immunity who have been exposed to varicella and who are at increased risk for severe disease and complications. The CDC's Advisory Committee on Immunization Practices recommends it for the following groups:

▸ Immunocompromised patients.

▸ Neonates whose mothers have signs and symptoms of varicella around the time of delivery (5 days before to 2 days after).

▸ Premature infants born at or after 28?weeks of gestation who are exposed during the neonatal period and whose mothers do not have evidence of immunity.

▸ Premature infants born before 28 weeks of gestation or who weigh 1,000 g or more at birth and were exposed during the neonatal period, regardless of maternal history of varicella disease or vaccination.

▸ Pregnant women.

The product is expected to provide maximum benefit when administered as soon as possible after exposure although it can still be effective if administered up to 96 hours after exposure (MMWR 2006;55[early release]: www.cdc.gov/mmwr

For other patients not included in the above groups and without evidence of immunity, the varicella vaccine is recommended for prophylaxis within 96 hours and possibly up to 120 hours post exposure, according to the report.

The CDC recommends that health care providers “should make every effort to obtain and administer VariZIG” when indicated.

It can be requested from the sole authorized U.S. distributor, FFF Enterprises (Temecula, Calif.), through its 24-hour telephone line, 800-843-7477.

The expanded access protocol received central institutional review board approval, meaning that the FDA does not require additional institutional review board approval at individual institutions, according to the CDC.

Pharmacists and health care providers who anticipate needing the product can acquire inventory in advance, and, as with any product used under an investigational new drug application, patients must be informed of its potential risks and benefits and must give their informed consent before using it.

Patients receiving the therapy should be observed closely for 28 days after exposure for signs and symptoms of varicella (VariZIG might prolong the incubation period by 1 week or more) and treated with acyclovir antiviral therapy if necessary.

When varicella vaccine is not contraindicated, patients receiving VariZIG should be subsequently vaccinated but only after a delay of 5 months. Vaccination is not necessary if the patient contracts varicella after receiving VariZIG.

If VariZIG is not available within 96 hours of exposure, a single intravenous dose of immune globulin should be considered as an alternative, at a recommended dose of 400 mg/kg, administered once.

The dwindling U.S. supply of varicella-zoster immune globulin has been replenished with a new unlicensed product made available under a Food and Drug Administration investigational new drug application, according to the Centers for Disease Control and Prevention.

An expanded access protocol for VariZIG (Cangene Corporation, Winnipeg, Canada) was granted in February as supplies of the only licensed U.S. varicella-zoster immune globulin (VZIG) product began to run out, following its discontinuation last October by the manufacturer, Public Health Biologic Laboratories of Boston.

VariZIG is intended for patients without evidence of immunity who have been exposed to varicella and who are at increased risk for severe disease and complications. The CDC's Advisory Committee on Immunization Practices recommends it for the following groups:

▸ Immunocompromised patients.

▸ Neonates whose mothers have signs and symptoms of varicella around the time of delivery (5 days before to 2 days after).

▸ Premature infants born at or after 28?weeks of gestation who are exposed during the neonatal period and whose mothers do not have evidence of immunity.

▸ Premature infants born before 28 weeks of gestation or who weigh 1,000 g or more at birth and were exposed during the neonatal period, regardless of maternal history of varicella disease or vaccination.

▸ Pregnant women.

The product is expected to provide maximum benefit when administered as soon as possible after exposure although it can still be effective if administered up to 96 hours after exposure (MMWR 2006;55[early release]: www.cdc.gov/mmwr

For other patients not included in the above groups and without evidence of immunity, the varicella vaccine is recommended for prophylaxis within 96 hours and possibly up to 120 hours post exposure, according to the report.

The CDC recommends that health care providers “should make every effort to obtain and administer VariZIG” when indicated.

It can be requested from the sole authorized U.S. distributor, FFF Enterprises (Temecula, Calif.), through its 24-hour telephone line, 800-843-7477.

The expanded access protocol received central institutional review board approval, meaning that the FDA does not require additional institutional review board approval at individual institutions, according to the CDC.

Pharmacists and health care providers who anticipate needing the product can acquire inventory in advance, and, as with any product used under an investigational new drug application, patients must be informed of its potential risks and benefits and must give their informed consent before using it.

Patients receiving the therapy should be observed closely for 28 days after exposure for signs and symptoms of varicella (VariZIG might prolong the incubation period by 1 week or more) and treated with acyclovir antiviral therapy if necessary.

When varicella vaccine is not contraindicated, patients receiving VariZIG should be subsequently vaccinated but only after a delay of 5 months. Vaccination is not necessary if the patient contracts varicella after receiving VariZIG.

If VariZIG is not available within 96 hours of exposure, a single intravenous dose of immune globulin should be considered as an alternative, at a recommended dose of 400 mg/kg, administered once.

The dwindling U.S. supply of varicella-zoster immune globulin has been replenished with a new unlicensed product made available under a Food and Drug Administration investigational new drug application, according to the Centers for Disease Control and Prevention.

An expanded access protocol for VariZIG (Cangene Corporation, Winnipeg, Canada) was granted in February as supplies of the only licensed U.S. varicella-zoster immune globulin (VZIG) product began to run out, following its discontinuation last October by the manufacturer, Public Health Biologic Laboratories of Boston.

VariZIG is intended for patients without evidence of immunity who have been exposed to varicella and who are at increased risk for severe disease and complications. The CDC's Advisory Committee on Immunization Practices recommends it for the following groups:

▸ Immunocompromised patients.

▸ Neonates whose mothers have signs and symptoms of varicella around the time of delivery (5 days before to 2 days after).

▸ Premature infants born at or after 28?weeks of gestation who are exposed during the neonatal period and whose mothers do not have evidence of immunity.

▸ Premature infants born before 28 weeks of gestation or who weigh 1,000 g or more at birth and were exposed during the neonatal period, regardless of maternal history of varicella disease or vaccination.

▸ Pregnant women.

The product is expected to provide maximum benefit when administered as soon as possible after exposure although it can still be effective if administered up to 96 hours after exposure (MMWR 2006;55[early release]: www.cdc.gov/mmwr

For other patients not included in the above groups and without evidence of immunity, the varicella vaccine is recommended for prophylaxis within 96 hours and possibly up to 120 hours post exposure, according to the report.

The CDC recommends that health care providers “should make every effort to obtain and administer VariZIG” when indicated.

It can be requested from the sole authorized U.S. distributor, FFF Enterprises (Temecula, Calif.), through its 24-hour telephone line, 800-843-7477.

The expanded access protocol received central institutional review board approval, meaning that the FDA does not require additional institutional review board approval at individual institutions, according to the CDC.

Pharmacists and health care providers who anticipate needing the product can acquire inventory in advance, and, as with any product used under an investigational new drug application, patients must be informed of its potential risks and benefits and must give their informed consent before using it.

Patients receiving the therapy should be observed closely for 28 days after exposure for signs and symptoms of varicella (VariZIG might prolong the incubation period by 1 week or more) and treated with acyclovir antiviral therapy if necessary.

When varicella vaccine is not contraindicated, patients receiving VariZIG should be subsequently vaccinated but only after a delay of 5 months. Vaccination is not necessary if the patient contracts varicella after receiving VariZIG.

If VariZIG is not available within 96 hours of exposure, a single intravenous dose of immune globulin should be considered as an alternative, at a recommended dose of 400 mg/kg, administered once.

Subclinical hyperthyroidism was linked to atrial fibrillation but not to other clinical cardiovascular conditions or deaths in a new study.

“We report an independent association of subclinical hyperthyroidism with incident atrial fibrillation but not with other clinical cardiovascular conditions or mortality,” reported Dr. Anne R. Cappola from the University of Pennsylvania in Philadelphia and her colleagues (JAMA 2006;295:1033–41).

The study examined the link between unrecognized thyroid dysfunction and cardiovascular risk, including atrial fibrillation, coronary heart disease, cerebrovascular disease, and death (cardiovascular and all-cause) in a subgroup of 3,233 participants in the population-based, longitudinal Cardiovascular Health Study. The study subjects were community-dwelling older adults with a mean age of 73 years who were followed for an average duration of 12.5 years.

At baseline, 82% of the cohort were euthyroid, 15% had subclinical hypothyroidism (TSH above 4.5 mU/L and below 20 mU/L with a normal FT4 concentration), 1.6% had overt hypothyroidism (TSH of at least 20 mU/L or TSH of more than 4.5 mU/L with a low FT4), and 1.5% had subclinical hyperthyroidism (TSH of 0.10–0.44 mU/L or less than 0.10 mU/L with a normal FT4). Individuals with overt hyperthyroidism, or thyrotoxicosis (TSH below 0.10 mU/L with an elevated FT4 level) were excluded because of the small sample size.

Because the aim of the study was to detect previously unrecognized thyroid dysfunction, potential subjects were excluded if they were taking thyroid medication at baseline. However, once thyroid dysfunction was identified, medication use was included in the analysis because of its potential effect on subsequent cardiovascular risk.

The study found no differences in cardiovascular events at baseline between the euthyroid group and any of the three groups with thyroid dysfunction.

However, over the 12.5-year follow-up period, subclinical hyperthyroidism emerged as a risk factor for atrial fibrillation, but for no other clinical cardiovascular conditions. Subjects with subclinical hyperthyroidism had a greater incidence of atrial fibrillation than did euthyroid subjects (67 vs. 31 events per 1,000 person-years). After adjustment, this risk was nearly double (hazard ratio, 1.98). None of the other thyroid abnormalities were associated with increased CVD risk.

The findings do not support thyroid screening in older adults simply to prevent atrial fibrillation, since the estimated number needed to screen would be 2,500 to detect 1 case of atrial fibrillation, the authors noted.

However, the data do support the treatment of subclinical hyperthyroidism when it is detected.

The authors disagree with an earlier expert panel report that cited insufficient evidence to treat patients with TSH levels of 0.1 mU/L-0.45 mU/L and recommended treating only those patients with TSH levels below 0.1 mU/L (JAMA 2004;291:228–38).

Subclinical hyperthyroidism was linked to atrial fibrillation but not to other clinical cardiovascular conditions or deaths in a new study.

“We report an independent association of subclinical hyperthyroidism with incident atrial fibrillation but not with other clinical cardiovascular conditions or mortality,” reported Dr. Anne R. Cappola from the University of Pennsylvania in Philadelphia and her colleagues (JAMA 2006;295:1033–41).

The study examined the link between unrecognized thyroid dysfunction and cardiovascular risk, including atrial fibrillation, coronary heart disease, cerebrovascular disease, and death (cardiovascular and all-cause) in a subgroup of 3,233 participants in the population-based, longitudinal Cardiovascular Health Study. The study subjects were community-dwelling older adults with a mean age of 73 years who were followed for an average duration of 12.5 years.

At baseline, 82% of the cohort were euthyroid, 15% had subclinical hypothyroidism (TSH above 4.5 mU/L and below 20 mU/L with a normal FT4 concentration), 1.6% had overt hypothyroidism (TSH of at least 20 mU/L or TSH of more than 4.5 mU/L with a low FT4), and 1.5% had subclinical hyperthyroidism (TSH of 0.10–0.44 mU/L or less than 0.10 mU/L with a normal FT4). Individuals with overt hyperthyroidism, or thyrotoxicosis (TSH below 0.10 mU/L with an elevated FT4 level) were excluded because of the small sample size.

Because the aim of the study was to detect previously unrecognized thyroid dysfunction, potential subjects were excluded if they were taking thyroid medication at baseline. However, once thyroid dysfunction was identified, medication use was included in the analysis because of its potential effect on subsequent cardiovascular risk.

The study found no differences in cardiovascular events at baseline between the euthyroid group and any of the three groups with thyroid dysfunction.

However, over the 12.5-year follow-up period, subclinical hyperthyroidism emerged as a risk factor for atrial fibrillation, but for no other clinical cardiovascular conditions. Subjects with subclinical hyperthyroidism had a greater incidence of atrial fibrillation than did euthyroid subjects (67 vs. 31 events per 1,000 person-years). After adjustment, this risk was nearly double (hazard ratio, 1.98). None of the other thyroid abnormalities were associated with increased CVD risk.

The findings do not support thyroid screening in older adults simply to prevent atrial fibrillation, since the estimated number needed to screen would be 2,500 to detect 1 case of atrial fibrillation, the authors noted.

However, the data do support the treatment of subclinical hyperthyroidism when it is detected.

The authors disagree with an earlier expert panel report that cited insufficient evidence to treat patients with TSH levels of 0.1 mU/L-0.45 mU/L and recommended treating only those patients with TSH levels below 0.1 mU/L (JAMA 2004;291:228–38).

Subclinical hyperthyroidism was linked to atrial fibrillation but not to other clinical cardiovascular conditions or deaths in a new study.

“We report an independent association of subclinical hyperthyroidism with incident atrial fibrillation but not with other clinical cardiovascular conditions or mortality,” reported Dr. Anne R. Cappola from the University of Pennsylvania in Philadelphia and her colleagues (JAMA 2006;295:1033–41).

The study examined the link between unrecognized thyroid dysfunction and cardiovascular risk, including atrial fibrillation, coronary heart disease, cerebrovascular disease, and death (cardiovascular and all-cause) in a subgroup of 3,233 participants in the population-based, longitudinal Cardiovascular Health Study. The study subjects were community-dwelling older adults with a mean age of 73 years who were followed for an average duration of 12.5 years.

At baseline, 82% of the cohort were euthyroid, 15% had subclinical hypothyroidism (TSH above 4.5 mU/L and below 20 mU/L with a normal FT4 concentration), 1.6% had overt hypothyroidism (TSH of at least 20 mU/L or TSH of more than 4.5 mU/L with a low FT4), and 1.5% had subclinical hyperthyroidism (TSH of 0.10–0.44 mU/L or less than 0.10 mU/L with a normal FT4). Individuals with overt hyperthyroidism, or thyrotoxicosis (TSH below 0.10 mU/L with an elevated FT4 level) were excluded because of the small sample size.

Because the aim of the study was to detect previously unrecognized thyroid dysfunction, potential subjects were excluded if they were taking thyroid medication at baseline. However, once thyroid dysfunction was identified, medication use was included in the analysis because of its potential effect on subsequent cardiovascular risk.

The study found no differences in cardiovascular events at baseline between the euthyroid group and any of the three groups with thyroid dysfunction.

However, over the 12.5-year follow-up period, subclinical hyperthyroidism emerged as a risk factor for atrial fibrillation, but for no other clinical cardiovascular conditions. Subjects with subclinical hyperthyroidism had a greater incidence of atrial fibrillation than did euthyroid subjects (67 vs. 31 events per 1,000 person-years). After adjustment, this risk was nearly double (hazard ratio, 1.98). None of the other thyroid abnormalities were associated with increased CVD risk.

The findings do not support thyroid screening in older adults simply to prevent atrial fibrillation, since the estimated number needed to screen would be 2,500 to detect 1 case of atrial fibrillation, the authors noted.

However, the data do support the treatment of subclinical hyperthyroidism when it is detected.

The authors disagree with an earlier expert panel report that cited insufficient evidence to treat patients with TSH levels of 0.1 mU/L-0.45 mU/L and recommended treating only those patients with TSH levels below 0.1 mU/L (JAMA 2004;291:228–38).

The dwindling U.S. supply of varicella-zoster immune globulin has been replenished with a new unlicensed product made available under a Food and Drug Administration investigational new drug application, according to the Centers for Disease Control and Prevention.

An expanded access protocol for VariZIG (Cangene Corporation, Winnipeg, Canada) was granted in February as supplies of the only licensed U.S. varicella-zoster immune globulin (VZIG) product began to run out, following its discontinuation last October by the manufacturer, Public Health Biologic Laboratories of Boston.

VariZIG is intended for patients without evidence of immunity who have been exposed to varicella and who are at increased risk for severe disease and complications. The CDC's Advisory Committee on Immunization Practices recommends it for the following groups:

▸ Immunocompromised patients.

▸ Neonates whose mothers have signs and symptoms of varicella around the time of delivery (5 days before to 2 days after).

▸ Premature infants born at or after 28 weeks of gestation who are exposed during the neonatal period and whose mothers do not have evidence of immunity.

▸ Premature infants born before 28 weeks of gestation or who weigh 1,000 g or more at birth and were exposed during the neonatal period, regardless of maternal history of varicella disease or vaccination.

▸ Pregnant women.

The product is expected to provide maximum benefit when administered as soon as possible after exposure although it can still be effective if administered up to 96 hours after exposure (MMWR 2006; 55[earlyrelease]:www.cdc.gov/mmwr

For other patients not included in the above groups and without evidence of immunity, the varicella vaccine is recommended for prophylaxis within 96 hours and possibly up to 120 hours post exposure, according to the report.

The CDC recommends that health care providers “should make every effort to obtain and administer VariZIG” when indicated. It can be requested from the sole authorized U.S. distributor, FFF Enterprises (Temecula, Calif.), through its 24-hour telephone line, 800–843–7477.

The expanded access protocol received central institutional review board approval, meaning that the FDA does not require additional institutional review board approval at individual institutions, according to the CDC.

Pharmacists and health care providers who anticipate needing the product can acquire inventory in advance, and, as with any product used under an investigational new drug (IND) application, patients must be informed of its potential risks and benefits and must give their informed consent before using it.

Patients receiving the therapy should be observed closely for 28 days after exposure for signs and symptoms of varicella (VariZIG might prolong the incubation period by 1 week or more) and treated with acyclovir antiviral therapy if necessary.

When varicella vaccine is not contraindicated, patients receiving VariZIG should be subsequently vaccinated but only after a delay of 5 months.

Vaccination is not necessary if the patient contracts varicella after receiving VariZIG.

If VariZIG is not available within 96 hours of exposure, a single dose of immune globulin intravenous should be considered as an alternative, at a recommended dose of 400 mg/kg, administered once.

The dwindling U.S. supply of varicella-zoster immune globulin has been replenished with a new unlicensed product made available under a Food and Drug Administration investigational new drug application, according to the Centers for Disease Control and Prevention.

An expanded access protocol for VariZIG (Cangene Corporation, Winnipeg, Canada) was granted in February as supplies of the only licensed U.S. varicella-zoster immune globulin (VZIG) product began to run out, following its discontinuation last October by the manufacturer, Public Health Biologic Laboratories of Boston.

VariZIG is intended for patients without evidence of immunity who have been exposed to varicella and who are at increased risk for severe disease and complications. The CDC's Advisory Committee on Immunization Practices recommends it for the following groups:

▸ Immunocompromised patients.

▸ Neonates whose mothers have signs and symptoms of varicella around the time of delivery (5 days before to 2 days after).

▸ Premature infants born at or after 28 weeks of gestation who are exposed during the neonatal period and whose mothers do not have evidence of immunity.

▸ Premature infants born before 28 weeks of gestation or who weigh 1,000 g or more at birth and were exposed during the neonatal period, regardless of maternal history of varicella disease or vaccination.

▸ Pregnant women.

The product is expected to provide maximum benefit when administered as soon as possible after exposure although it can still be effective if administered up to 96 hours after exposure (MMWR 2006; 55[earlyrelease]:www.cdc.gov/mmwr

For other patients not included in the above groups and without evidence of immunity, the varicella vaccine is recommended for prophylaxis within 96 hours and possibly up to 120 hours post exposure, according to the report.

The CDC recommends that health care providers “should make every effort to obtain and administer VariZIG” when indicated. It can be requested from the sole authorized U.S. distributor, FFF Enterprises (Temecula, Calif.), through its 24-hour telephone line, 800–843–7477.

The expanded access protocol received central institutional review board approval, meaning that the FDA does not require additional institutional review board approval at individual institutions, according to the CDC.

Pharmacists and health care providers who anticipate needing the product can acquire inventory in advance, and, as with any product used under an investigational new drug (IND) application, patients must be informed of its potential risks and benefits and must give their informed consent before using it.

Patients receiving the therapy should be observed closely for 28 days after exposure for signs and symptoms of varicella (VariZIG might prolong the incubation period by 1 week or more) and treated with acyclovir antiviral therapy if necessary.

When varicella vaccine is not contraindicated, patients receiving VariZIG should be subsequently vaccinated but only after a delay of 5 months.

Vaccination is not necessary if the patient contracts varicella after receiving VariZIG.

If VariZIG is not available within 96 hours of exposure, a single dose of immune globulin intravenous should be considered as an alternative, at a recommended dose of 400 mg/kg, administered once.

The dwindling U.S. supply of varicella-zoster immune globulin has been replenished with a new unlicensed product made available under a Food and Drug Administration investigational new drug application, according to the Centers for Disease Control and Prevention.

An expanded access protocol for VariZIG (Cangene Corporation, Winnipeg, Canada) was granted in February as supplies of the only licensed U.S. varicella-zoster immune globulin (VZIG) product began to run out, following its discontinuation last October by the manufacturer, Public Health Biologic Laboratories of Boston.

VariZIG is intended for patients without evidence of immunity who have been exposed to varicella and who are at increased risk for severe disease and complications. The CDC's Advisory Committee on Immunization Practices recommends it for the following groups:

▸ Immunocompromised patients.

▸ Neonates whose mothers have signs and symptoms of varicella around the time of delivery (5 days before to 2 days after).

▸ Premature infants born at or after 28 weeks of gestation who are exposed during the neonatal period and whose mothers do not have evidence of immunity.

▸ Premature infants born before 28 weeks of gestation or who weigh 1,000 g or more at birth and were exposed during the neonatal period, regardless of maternal history of varicella disease or vaccination.

▸ Pregnant women.

The product is expected to provide maximum benefit when administered as soon as possible after exposure although it can still be effective if administered up to 96 hours after exposure (MMWR 2006; 55[earlyrelease]:www.cdc.gov/mmwr

For other patients not included in the above groups and without evidence of immunity, the varicella vaccine is recommended for prophylaxis within 96 hours and possibly up to 120 hours post exposure, according to the report.

The CDC recommends that health care providers “should make every effort to obtain and administer VariZIG” when indicated. It can be requested from the sole authorized U.S. distributor, FFF Enterprises (Temecula, Calif.), through its 24-hour telephone line, 800–843–7477.

The expanded access protocol received central institutional review board approval, meaning that the FDA does not require additional institutional review board approval at individual institutions, according to the CDC.

Pharmacists and health care providers who anticipate needing the product can acquire inventory in advance, and, as with any product used under an investigational new drug (IND) application, patients must be informed of its potential risks and benefits and must give their informed consent before using it.

Patients receiving the therapy should be observed closely for 28 days after exposure for signs and symptoms of varicella (VariZIG might prolong the incubation period by 1 week or more) and treated with acyclovir antiviral therapy if necessary.

When varicella vaccine is not contraindicated, patients receiving VariZIG should be subsequently vaccinated but only after a delay of 5 months.

Vaccination is not necessary if the patient contracts varicella after receiving VariZIG.

If VariZIG is not available within 96 hours of exposure, a single dose of immune globulin intravenous should be considered as an alternative, at a recommended dose of 400 mg/kg, administered once.

ORLANDO — Older women with a family history of breast cancer place extraordinary faith in mammography over clinical breast exam for reassurance about their breast health, according to Karen Greco, R.N., Ph.D., lead investigator of a small, qualitative study on mammography decision making in this population.

Furthermore, many of these women may not appreciate their potentially increased risk for hereditary cancer syndromes, added Dr. Greco, who presented her study as a poster at the annual meeting of the Gerontological Society of America.

“The women in my study were not aware that if they had a first-degree relative with breast cancer and another one with ovarian cancer, that there was a connection,” she said in an interview. “Although some had been asked about family history they didn't understand what it meant, and they didn't understand the significance.”

Ten of the 16 women in her study had family histories that suggested they could be at risk for a hereditary cancer syndrome, yet they reported they had not received a cancer risk assessment, said Dr. Greco of the Oregon Health & Science University School of Nursing in West Linn.

The study included 16 women over age 65 years (average age 73) who were at increased risk for breast cancer because of both family history—defined as at least one first-degree relative diagnosed with breast cancer—and advancing age.

Open-ended, semistructured interviews were conducted with the women to explore their decisions about screening mammography.

Although 15 of the 16 women had regular visits with their health care provider, and 14 had regular mammograms, less than half (7) said they received regular clinical breast exams, Dr. Greco said.

“Many said they believed very strongly that mammography is more effective than clinical breast exam or self-[administered] breast exam because 'mammograms can see inside me',” she said.

“There was extraordinary confidence in mammography to the point that if women heard negative information about the effectiveness of mammograms, they ignored it,” Dr. Greco added

In addition, many women entertained the mistaken belief that their risk for breast cancer decreased with age, she said.

“We may need to look more at what older women's beliefs are about cancer risk and age because they don't all believe that increased age increases their risk,” she said.

The study highlights the emotional consequences of mammography in high-risk women, Dr. Greco noted.

Women described their worry if they were asked to return because of an abnormal finding, and they described decreased worry if they were given their results immediately.

“It may be helpful for physicians to know that for high-risk women, having mammograms is an emotional experience, and we may need to look at providing them with some emotional support,” she said.

ORLANDO — Older women with a family history of breast cancer place extraordinary faith in mammography over clinical breast exam for reassurance about their breast health, according to Karen Greco, R.N., Ph.D., lead investigator of a small, qualitative study on mammography decision making in this population.

Furthermore, many of these women may not appreciate their potentially increased risk for hereditary cancer syndromes, added Dr. Greco, who presented her study as a poster at the annual meeting of the Gerontological Society of America.

“The women in my study were not aware that if they had a first-degree relative with breast cancer and another one with ovarian cancer, that there was a connection,” she said in an interview. “Although some had been asked about family history they didn't understand what it meant, and they didn't understand the significance.”

Ten of the 16 women in her study had family histories that suggested they could be at risk for a hereditary cancer syndrome, yet they reported they had not received a cancer risk assessment, said Dr. Greco of the Oregon Health & Science University School of Nursing in West Linn.

The study included 16 women over age 65 years (average age 73) who were at increased risk for breast cancer because of both family history—defined as at least one first-degree relative diagnosed with breast cancer—and advancing age.

Open-ended, semistructured interviews were conducted with the women to explore their decisions about screening mammography.

Although 15 of the 16 women had regular visits with their health care provider, and 14 had regular mammograms, less than half (7) said they received regular clinical breast exams, Dr. Greco said.

“Many said they believed very strongly that mammography is more effective than clinical breast exam or self-[administered] breast exam because 'mammograms can see inside me',” she said.

“There was extraordinary confidence in mammography to the point that if women heard negative information about the effectiveness of mammograms, they ignored it,” Dr. Greco added

In addition, many women entertained the mistaken belief that their risk for breast cancer decreased with age, she said.

“We may need to look more at what older women's beliefs are about cancer risk and age because they don't all believe that increased age increases their risk,” she said.

The study highlights the emotional consequences of mammography in high-risk women, Dr. Greco noted.

Women described their worry if they were asked to return because of an abnormal finding, and they described decreased worry if they were given their results immediately.

“It may be helpful for physicians to know that for high-risk women, having mammograms is an emotional experience, and we may need to look at providing them with some emotional support,” she said.

ORLANDO — Older women with a family history of breast cancer place extraordinary faith in mammography over clinical breast exam for reassurance about their breast health, according to Karen Greco, R.N., Ph.D., lead investigator of a small, qualitative study on mammography decision making in this population.

Furthermore, many of these women may not appreciate their potentially increased risk for hereditary cancer syndromes, added Dr. Greco, who presented her study as a poster at the annual meeting of the Gerontological Society of America.

“The women in my study were not aware that if they had a first-degree relative with breast cancer and another one with ovarian cancer, that there was a connection,” she said in an interview. “Although some had been asked about family history they didn't understand what it meant, and they didn't understand the significance.”

Ten of the 16 women in her study had family histories that suggested they could be at risk for a hereditary cancer syndrome, yet they reported they had not received a cancer risk assessment, said Dr. Greco of the Oregon Health & Science University School of Nursing in West Linn.

The study included 16 women over age 65 years (average age 73) who were at increased risk for breast cancer because of both family history—defined as at least one first-degree relative diagnosed with breast cancer—and advancing age.

Open-ended, semistructured interviews were conducted with the women to explore their decisions about screening mammography.

Although 15 of the 16 women had regular visits with their health care provider, and 14 had regular mammograms, less than half (7) said they received regular clinical breast exams, Dr. Greco said.

“Many said they believed very strongly that mammography is more effective than clinical breast exam or self-[administered] breast exam because 'mammograms can see inside me',” she said.

“There was extraordinary confidence in mammography to the point that if women heard negative information about the effectiveness of mammograms, they ignored it,” Dr. Greco added

In addition, many women entertained the mistaken belief that their risk for breast cancer decreased with age, she said.

“We may need to look more at what older women's beliefs are about cancer risk and age because they don't all believe that increased age increases their risk,” she said.

The study highlights the emotional consequences of mammography in high-risk women, Dr. Greco noted.

Women described their worry if they were asked to return because of an abnormal finding, and they described decreased worry if they were given their results immediately.

“It may be helpful for physicians to know that for high-risk women, having mammograms is an emotional experience, and we may need to look at providing them with some emotional support,” she said.