Last week, Reuters reported that 4,100 children suffered birth defects because their mother took Sanofi epilepsy drug valproate, or valproic acid, while pregnant. In 2010, WebMD reported that women who took the drug during their first trimester were “more likely to have children with birth defects than women who took other epilepsy drugs or no medicine to control their seizures during pregnancy.” Those defects include spina bifida, a hole in the heart, cleft palate, a urethra abnormality, extra fingers or toes, and craniosynostosis. Attorney Tom Robenalt welcomes you to contact his office with any questions you have about filing a claim against Sanofi. Below, you’ll find frequently asked questions about the manufacturer’s anticonvulsant.
What Is Valproate?
Valproate is an FDA-approved drug that controls epileptic seizures by stabilizing electrical activity in the brain, NetDoctor said. “It is thought to achieve this by increasing the activity of a natural ‘nerve-calming’ agent called GABA in the brain.” Doctors also prescribe valproate to treat bipolar disorder and migraines. Brand names include Depakote, Depakene, and Stavzor.
How High Is the Risk of Birth Defects After Taking the Sanofi Epilepsy Drug?
Financial Times reported that the risk of birth defects was four times higher when women took valproate for epilepsy and two times higher when they took it for bipolar disorder. This is because women with bipolar disorder were prescribed the drug less often, the publication said.
Were Pregnant Women Warned About Potential Birth Defects?
According to Reuters, parents have said Sanofi failed to warn parents about potential adverse side effects quickly enough. Once potential birth defects were brought to the FDA’s attention, the agency issued the following advisories:
- December 3, 2009, the FDA said valproate sodium exposure during pregnancy could cause neural tube and other birth defects. It advised healthcare professionals to warn women about these risks. “In the United States, about 1 in 1500 babies is born with a neural tube defect,” it said. “The risk of neural tube defects is much higher in babies born to mothers treated with valproate during the first 12 weeks of pregnancy, with the risk increasing to 1 in 20 babies.”
- June 30, 2011, the FDA said it would be revising valproate labels to warn women that “children exposed to these drugs in utero (during pregnancy) have a higher risk for lower cognitive test scores.” Cognition involves intelligence, reasoning, and problem solving, it said. “The labels of valproate drugs already include warning information about … an increased risk of serious neural tube birth defects (e.g., spina bifida) and other major birth defects.” During a July 1, 2011, podcast, an FDA pharmacist said long-term effects on IQ were unknown.
- May 6, 2013, the FDA said drug labels would be strengthened again to warn women that the risks of taking valproate during pregnancy to treat migraines outweighed the drug’s potential benefit. The FDA reiterated that pregnant women with epilepsy or bipolar disorder should only take valproate if other medications failed to treat their condition.
Has Sanofi Been Sued Before?
Sanofi was named in a class-action lawsuit in January, and one of the company’s former paralegals filed a whistleblower lawsuit against the company in 2014. In 2015, CNBC reported that “she was aware of ‘many instances’ where Sanofi lawyers destroyed documents to avoid turning them over to opponents in prior legal cases.”
Contact Sanofi Epilepsy Drug Birth Defect Attorney Tom Robenalt with Your Questions
If you have questions about how to file a claim against Sanofi for the recklessness that caused birth defects, contact attorney Tom Robenalt by calling 216-223-7535, submitting this form, or emailing [email protected] today.