Up to 4,100 children in France were born with major congenital malformations between 1967 and 2016 after their mothers took the epilepsy medication Depakote (generic: valproic acid) during pregnancy, France’s drug regulator has announced.
Free Confidential Lawsuit Evaluation: If your child or other loved one was born with a birth defect after the mother took Depakote during pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
What’s the Problem?
April 20, 2017 – Pregnant women who took Depakote for epilepsy treatment were 4 times more likely to give birth to babies with major congenital defects compared to women who did not take the drug, according to the study, which was conducted by the French National Agency for the Safety of Medicines (ANSM) and the national health insurance administration.
Birth defects linked to Depakote include spina bifida, heart malformations and genital defects.
“The study confirms the highly teratogenic nature of valproate,” said Mahmoud Zureik, scientific director of ANSM and a co-author of the report. “The figure of about 3,000 severe malformations is very high.”
From 1967 to 2016, between 64,100 and 100,000 women took valproate during pregnancy, resulting in 41,200 to 75,300 live births, the study found. Most of the defects occurred in women who were being treated for epilepsy.
However, starting in the late 1970s, valproate started being prescribed in France to treat bipolar disorder. Bipolar women taking the drug were twice as likely to give birth to children with major congenital defects, according to the researchers.
The lower risk compared with women treated for epilepsy likely stems from the fact that doctors stopped prescribing valproate early in pregnancy for the treatment of bipolar.
Valproate, which is manufactured in France by Sanofi as Depakine for epilepsy treatment and Depakote and Depamide for bipolar disorders, is also believed to cause slow neurological development.
ANSM said it would also publish a study on the neurological effects of Depakote later this year.
Do I Have a Depakote Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Depakote lawsuits. We are handling individual litigation nationwide and currently accepting new birth defects cases in all 50 states.
Free Case Evaluation: Again, if your child was born with a Depakote birth defect, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.