Valproate Still Often Prescribed to Women Despite Birth Defect Risk

[Guest guest]

Valproate Still Often Prescribed to Women Despite Birth Defect Risk

http://www.medscape.com/viewarticle/737986

February 25, 2011 — Despite well-documented evidence of an increased risk for birth defects and neurocognitive deficits, the anticonvulsant valproate is still commonly prescribed to women of childbearing age.

A new study shows that more than 20% of childbearing-age women with a psychiatric disorder who receive a nonantipsychotic mood stabilizer were treated with valproate.

"Valproate was the most frequently prescribed non-antipsychotic mood stabilizer for women of childbearing age," the authors, led by L. Wisner, MD, Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania, write.

The study is published in the February issue of Psychiatric Services.

Serious Adverse Outcomes

Widely used to treat bipolar disorder, research shows valproate increases the risk of developing polycystic ovarian syndrome. In addition, valproate increases the rates of birth defects and developmental delay in children exposed in utero.

The most recent research from the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study, released in December 2010 and reported by Medscape Medical News at that time, shows that prenatal exposure to the drug increases the risk for long-term cognitive deficits in offspring.

In addition to cognitive impairment, the authors point out that compared with other anticonvulsants, gestational exposure to valproate is associated with higher rates of serious adverse outcomes, including congenital malformations and fetal death.

Furthermore, previous research by NEAD investigators and also reported by Medscape Medical News showed that 3-year-old children exposed to valproate had average IQ scores 9 points lower than those exposed to lamotrigine and 6 points lower than those exposed to carbamazepine.

In addition, in 2009 the US Food and Drug Administration issued a safety alert warning about the risk for neural tube defects, craniofacial defects, and cardiovascular malformations in infants exposed to valproate during pregnancy.

Commonly Prescribed

Against this background, the researchers determined the rates of valproate use in women of childbearing age to assess current prescribing prevalence.

Using New York State Medicaid claims for persons with psychiatric disorders, 40,526 individuals with active prescriptions for nonantipsychotic mood stabilizers on May 1, 2009, were identified. Investigators compared valproate use among women of childbearing age, defined as those between 15 and 49 years, with similarly aged men and women age 50 years and older.

In the study sample, diagnoses included bipolar disorder (24.0%), major depression or dysthymia (22.9%), schizophrenia (18.7%), anxiety disorders (8.5%), and other diagnoses (13.3%); 12.5% were missing data that indicated a psychiatric diagnosis.

The researchers report that in the entire sample valproate was the most frequently prescribed nonantipsychotic mood stabilizer (32.3%), followed by gabapentin (26.4%), lamotrigine (16.7%), topiramate (13.%), lithium (13.0%), oxcarbazepine (5.1%), and carbamazepine (3.2%).

While young women were less likely than men or older women to be prescribed valproate, the results revealed that at 23.4%, valproate was still the most commonly prescribed agent for young women.

Opportunity to Inform

The investigators point out that even after exclusion of patients with a seizure disorder from the analysis, patients with a wide variety of psychiatric diagnoses received anticonvulsants. They note that only a minority of the study participants had a diagnosis of bipolar disorder.

Although the literature does not support gabapentin or other anticonvulsive agents as being effective for bipolar disorder, gabapentin was the second most prescribed anticonvulsant in the New York State Medicaid mental health population and the most common agent prescribed to older women.

"Over 20% of childbearing-aged women receiving mood stabilizers were treated with valproate, although increasing data on the reproductive toxicity of this agent compel consideration of other non-antipsychotic mood stabilizers as first-line choices," the authors write.

They add that "reducing the rate of first-line valproate use among women of childbearing age creates an opportunity for prevention of reproductive toxicity. Informing patients and providers about the comparative reproductive risks among mood stabilizers as well as about the evidence to support the efficacy of only a subset of anticonvulsants for bipolar disorder is a necessary component of influencing practice patterns."

The study was conducted and funded under the auspices of the New York State Office of Mental health Psychiatric Services and Clinical Knowledge Enhancement Initiative. Dr. Wisner's work was supported by a grant from the National Institute of Mental Health (NIMH).

Dr. Wisner reports serving on an advisory board for Eli Lilly and Company and received a donation of estradiol and matching placebo transdermal patches from Novartis for use in an NIMH-funded randomized clinical trial. The disclosures of the other authors can be viewed in the original study.

Psychiatr Serv. 2011; 62:218-220. Abstract

[Guest guest]

Valproate Still Often Prescribed to Women Despite Birth Defect Risk

http://www.medscape.com/viewarticle/737986

February 25, 2011 — Despite well-documented evidence of an increased risk for birth defects and neurocognitive deficits, the anticonvulsant valproate is still commonly prescribed to women of childbearing age.

A new study shows that more than 20% of childbearing-age women with a psychiatric disorder who receive a nonantipsychotic mood stabilizer were treated with valproate.

"Valproate was the most frequently prescribed non-antipsychotic mood stabilizer for women of childbearing age," the authors, led by L. Wisner, MD, Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania, write.

The study is published in the February issue of Psychiatric Services.

Serious Adverse Outcomes

Widely used to treat bipolar disorder, research shows valproate increases the risk of developing polycystic ovarian syndrome. In addition, valproate increases the rates of birth defects and developmental delay in children exposed in utero.

The most recent research from the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study, released in December 2010 and reported by Medscape Medical News at that time, shows that prenatal exposure to the drug increases the risk for long-term cognitive deficits in offspring.

In addition to cognitive impairment, the authors point out that compared with other anticonvulsants, gestational exposure to valproate is associated with higher rates of serious adverse outcomes, including congenital malformations and fetal death.

Furthermore, previous research by NEAD investigators and also reported by Medscape Medical News showed that 3-year-old children exposed to valproate had average IQ scores 9 points lower than those exposed to lamotrigine and 6 points lower than those exposed to carbamazepine.

In addition, in 2009 the US Food and Drug Administration issued a safety alert warning about the risk for neural tube defects, craniofacial defects, and cardiovascular malformations in infants exposed to valproate during pregnancy.

Commonly Prescribed

Against this background, the researchers determined the rates of valproate use in women of childbearing age to assess current prescribing prevalence.

Using New York State Medicaid claims for persons with psychiatric disorders, 40,526 individuals with active prescriptions for nonantipsychotic mood stabilizers on May 1, 2009, were identified. Investigators compared valproate use among women of childbearing age, defined as those between 15 and 49 years, with similarly aged men and women age 50 years and older.

In the study sample, diagnoses included bipolar disorder (24.0%), major depression or dysthymia (22.9%), schizophrenia (18.7%), anxiety disorders (8.5%), and other diagnoses (13.3%); 12.5% were missing data that indicated a psychiatric diagnosis.

The researchers report that in the entire sample valproate was the most frequently prescribed nonantipsychotic mood stabilizer (32.3%), followed by gabapentin (26.4%), lamotrigine (16.7%), topiramate (13.%), lithium (13.0%), oxcarbazepine (5.1%), and carbamazepine (3.2%).

While young women were less likely than men or older women to be prescribed valproate, the results revealed that at 23.4%, valproate was still the most commonly prescribed agent for young women.

Opportunity to Inform

The investigators point out that even after exclusion of patients with a seizure disorder from the analysis, patients with a wide variety of psychiatric diagnoses received anticonvulsants. They note that only a minority of the study participants had a diagnosis of bipolar disorder.

Although the literature does not support gabapentin or other anticonvulsive agents as being effective for bipolar disorder, gabapentin was the second most prescribed anticonvulsant in the New York State Medicaid mental health population and the most common agent prescribed to older women.

"Over 20% of childbearing-aged women receiving mood stabilizers were treated with valproate, although increasing data on the reproductive toxicity of this agent compel consideration of other non-antipsychotic mood stabilizers as first-line choices," the authors write.

They add that "reducing the rate of first-line valproate use among women of childbearing age creates an opportunity for prevention of reproductive toxicity. Informing patients and providers about the comparative reproductive risks among mood stabilizers as well as about the evidence to support the efficacy of only a subset of anticonvulsants for bipolar disorder is a necessary component of influencing practice patterns."

The study was conducted and funded under the auspices of the New York State Office of Mental health Psychiatric Services and Clinical Knowledge Enhancement Initiative. Dr. Wisner's work was supported by a grant from the National Institute of Mental Health (NIMH).

Dr. Wisner reports serving on an advisory board for Eli Lilly and Company and received a donation of estradiol and matching placebo transdermal patches from Novartis for use in an NIMH-funded randomized clinical trial. The disclosures of the other authors can be viewed in the original study.

Psychiatr Serv. 2011; 62:218-220. Abstract

[Guest guest]

Valproate Still Often Prescribed to Women Despite Birth Defect Risk

http://www.medscape.com/viewarticle/737986

February 25, 2011 — Despite well-documented evidence of an increased risk for birth defects and neurocognitive deficits, the anticonvulsant valproate is still commonly prescribed to women of childbearing age.

A new study shows that more than 20% of childbearing-age women with a psychiatric disorder who receive a nonantipsychotic mood stabilizer were treated with valproate.

"Valproate was the most frequently prescribed non-antipsychotic mood stabilizer for women of childbearing age," the authors, led by L. Wisner, MD, Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania, write.

The study is published in the February issue of Psychiatric Services.

Serious Adverse Outcomes

Widely used to treat bipolar disorder, research shows valproate increases the risk of developing polycystic ovarian syndrome. In addition, valproate increases the rates of birth defects and developmental delay in children exposed in utero.

The most recent research from the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study, released in December 2010 and reported by Medscape Medical News at that time, shows that prenatal exposure to the drug increases the risk for long-term cognitive deficits in offspring.

In addition to cognitive impairment, the authors point out that compared with other anticonvulsants, gestational exposure to valproate is associated with higher rates of serious adverse outcomes, including congenital malformations and fetal death.

Furthermore, previous research by NEAD investigators and also reported by Medscape Medical News showed that 3-year-old children exposed to valproate had average IQ scores 9 points lower than those exposed to lamotrigine and 6 points lower than those exposed to carbamazepine.

In addition, in 2009 the US Food and Drug Administration issued a safety alert warning about the risk for neural tube defects, craniofacial defects, and cardiovascular malformations in infants exposed to valproate during pregnancy.

Commonly Prescribed

Against this background, the researchers determined the rates of valproate use in women of childbearing age to assess current prescribing prevalence.

Using New York State Medicaid claims for persons with psychiatric disorders, 40,526 individuals with active prescriptions for nonantipsychotic mood stabilizers on May 1, 2009, were identified. Investigators compared valproate use among women of childbearing age, defined as those between 15 and 49 years, with similarly aged men and women age 50 years and older.

In the study sample, diagnoses included bipolar disorder (24.0%), major depression or dysthymia (22.9%), schizophrenia (18.7%), anxiety disorders (8.5%), and other diagnoses (13.3%); 12.5% were missing data that indicated a psychiatric diagnosis.

The researchers report that in the entire sample valproate was the most frequently prescribed nonantipsychotic mood stabilizer (32.3%), followed by gabapentin (26.4%), lamotrigine (16.7%), topiramate (13.%), lithium (13.0%), oxcarbazepine (5.1%), and carbamazepine (3.2%).

While young women were less likely than men or older women to be prescribed valproate, the results revealed that at 23.4%, valproate was still the most commonly prescribed agent for young women.

Opportunity to Inform

The investigators point out that even after exclusion of patients with a seizure disorder from the analysis, patients with a wide variety of psychiatric diagnoses received anticonvulsants. They note that only a minority of the study participants had a diagnosis of bipolar disorder.

Although the literature does not support gabapentin or other anticonvulsive agents as being effective for bipolar disorder, gabapentin was the second most prescribed anticonvulsant in the New York State Medicaid mental health population and the most common agent prescribed to older women.

"Over 20% of childbearing-aged women receiving mood stabilizers were treated with valproate, although increasing data on the reproductive toxicity of this agent compel consideration of other non-antipsychotic mood stabilizers as first-line choices," the authors write.

They add that "reducing the rate of first-line valproate use among women of childbearing age creates an opportunity for prevention of reproductive toxicity. Informing patients and providers about the comparative reproductive risks among mood stabilizers as well as about the evidence to support the efficacy of only a subset of anticonvulsants for bipolar disorder is a necessary component of influencing practice patterns."

The study was conducted and funded under the auspices of the New York State Office of Mental health Psychiatric Services and Clinical Knowledge Enhancement Initiative. Dr. Wisner's work was supported by a grant from the National Institute of Mental Health (NIMH).

Dr. Wisner reports serving on an advisory board for Eli Lilly and Company and received a donation of estradiol and matching placebo transdermal patches from Novartis for use in an NIMH-funded randomized clinical trial. The disclosures of the other authors can be viewed in the original study.

Psychiatr Serv. 2011; 62:218-220. Abstract

[Guest guest]

Valproate Still Often Prescribed to Women Despite Birth Defect Risk

http://www.medscape.com/viewarticle/737986

February 25, 2011 — Despite well-documented evidence of an increased risk for birth defects and neurocognitive deficits, the anticonvulsant valproate is still commonly prescribed to women of childbearing age.

A new study shows that more than 20% of childbearing-age women with a psychiatric disorder who receive a nonantipsychotic mood stabilizer were treated with valproate.

"Valproate was the most frequently prescribed non-antipsychotic mood stabilizer for women of childbearing age," the authors, led by L. Wisner, MD, Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania, write.

The study is published in the February issue of Psychiatric Services.

Serious Adverse Outcomes

Widely used to treat bipolar disorder, research shows valproate increases the risk of developing polycystic ovarian syndrome. In addition, valproate increases the rates of birth defects and developmental delay in children exposed in utero.

The most recent research from the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study, released in December 2010 and reported by Medscape Medical News at that time, shows that prenatal exposure to the drug increases the risk for long-term cognitive deficits in offspring.

In addition to cognitive impairment, the authors point out that compared with other anticonvulsants, gestational exposure to valproate is associated with higher rates of serious adverse outcomes, including congenital malformations and fetal death.

Furthermore, previous research by NEAD investigators and also reported by Medscape Medical News showed that 3-year-old children exposed to valproate had average IQ scores 9 points lower than those exposed to lamotrigine and 6 points lower than those exposed to carbamazepine.

In addition, in 2009 the US Food and Drug Administration issued a safety alert warning about the risk for neural tube defects, craniofacial defects, and cardiovascular malformations in infants exposed to valproate during pregnancy.

Commonly Prescribed

Against this background, the researchers determined the rates of valproate use in women of childbearing age to assess current prescribing prevalence.

Using New York State Medicaid claims for persons with psychiatric disorders, 40,526 individuals with active prescriptions for nonantipsychotic mood stabilizers on May 1, 2009, were identified. Investigators compared valproate use among women of childbearing age, defined as those between 15 and 49 years, with similarly aged men and women age 50 years and older.

In the study sample, diagnoses included bipolar disorder (24.0%), major depression or dysthymia (22.9%), schizophrenia (18.7%), anxiety disorders (8.5%), and other diagnoses (13.3%); 12.5% were missing data that indicated a psychiatric diagnosis.

The researchers report that in the entire sample valproate was the most frequently prescribed nonantipsychotic mood stabilizer (32.3%), followed by gabapentin (26.4%), lamotrigine (16.7%), topiramate (13.%), lithium (13.0%), oxcarbazepine (5.1%), and carbamazepine (3.2%).

While young women were less likely than men or older women to be prescribed valproate, the results revealed that at 23.4%, valproate was still the most commonly prescribed agent for young women.

Opportunity to Inform

The investigators point out that even after exclusion of patients with a seizure disorder from the analysis, patients with a wide variety of psychiatric diagnoses received anticonvulsants. They note that only a minority of the study participants had a diagnosis of bipolar disorder.

Although the literature does not support gabapentin or other anticonvulsive agents as being effective for bipolar disorder, gabapentin was the second most prescribed anticonvulsant in the New York State Medicaid mental health population and the most common agent prescribed to older women.

"Over 20% of childbearing-aged women receiving mood stabilizers were treated with valproate, although increasing data on the reproductive toxicity of this agent compel consideration of other non-antipsychotic mood stabilizers as first-line choices," the authors write.

They add that "reducing the rate of first-line valproate use among women of childbearing age creates an opportunity for prevention of reproductive toxicity. Informing patients and providers about the comparative reproductive risks among mood stabilizers as well as about the evidence to support the efficacy of only a subset of anticonvulsants for bipolar disorder is a necessary component of influencing practice patterns."

The study was conducted and funded under the auspices of the New York State Office of Mental health Psychiatric Services and Clinical Knowledge Enhancement Initiative. Dr. Wisner's work was supported by a grant from the National Institute of Mental Health (NIMH).

Dr. Wisner reports serving on an advisory board for Eli Lilly and Company and received a donation of estradiol and matching placebo transdermal patches from Novartis for use in an NIMH-funded randomized clinical trial. The disclosures of the other authors can be viewed in the original study.

Psychiatr Serv. 2011; 62:218-220. Abstract