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Despite concerns about the birth defect risks with Depakote, French health experts indicate that more than 10,000 pregnant women were exposed to epilepsy drug between 2007 and 2014.
In a study conducted by the country’s national drug agency, ANSM and CNAMTS, a health insurance agency said the French women were prescribed the anti-epilepsy drug, known there as Depakine, despite the risk of malformations or other birth defects, which have been known for decades.
The findings will be presented later this month, and the French health ministry has said it will present an action plan in September, according to a report by Reuters News.
The French government has been accused of trying to delay the study, which it’s ministry of health denies. An earlier study, released in February, claimed that only about 450 children in France had been exposed to the drug.
Depakote was approved in the United States in 1978 for treatment of certain forms of epilepsy, containing the active ingredient valproic acid. However, pregnancy side effects of Depakote have been linked to a number of severe birth defects, including spina bifida, cleft palate, abnormal skull development, malformed limbs, holes in the heart and urinary tract problems; especially when the drug is taken during the first 28 days, when neural tube closure and other critical formations are taking place.
In 2006, the FDA added a “black box” warning in the United States about the potential Depakote birth defects risks, after a study found that 20% of pregnant mothers who gave birth while on Depakote had a child with malformations or a birth defect.
In May 2013, the FDA put new restrictions on Depakote pregnancy use, contraindicating it for pregnant women, but only when it was used for the treatment of migraines. The agency did not contraindicate it for pregnant women using it to treat epilepsy. The FDA changed all valproate-based drugs from a class “D” to a class “X” pregnancy drug, but only as they pertain to migraines.
Before the drug’s patent expired in 2007, Depakote was a blockbuster drug generating about $1.5 billion in annual sales for AbbVie’s predecessor. In France and some other countries the drug is known as Depakene.
In the U.S., the drug is distributed by AbbVie and Abbott Laboratories. In France, it is distributed by Sanofi.
Abbott Laboratories and AbbVie, a subsidiary it spun off, have faced hundreds of Depakote lawsuits in state and federal courts nationwide. Plaintiffs say the company should be held liable for failing to warn women and the medical community about the risks associated with using the medication during pregnancy.