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Sanofi faces charges in France that it downplayed the birth defects risk linked to its antiepilepsy drug Depakine, which is sold under the brand name Depakote in the United States.
Officials with the drug manufacturer told the French press this week that prosecutors in France are charging the company with aggravated fraud and unintentional injury linked to Depakine birth defects. However, due to how the French system works the charges may not result in a trial.
The U.S. version of the anti-seizure drug, Depakote (valproate), was approved by the FDA in 1978, for treatment of certain forms of epilepsy. Both drugs contain the active ingredient valproic acid.
While the medications are widely used, 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.
French prosecutors first launched an investigation in September 2016, after lawsuits were filed by individuals in that country who said the company misled them about the risks of valproate-based epilepsy drugs during pregnancy. Regulators in the country determined the pharmaceutical company failed to provide adequate warnings about the drug’s link to birth defects.
A study published that summer by France’s national drug agency, ANSM and CNAMTS, a health insurance agency, found that more than 10,000 pregnant French women were exposed to Depakote between 2007 and 2014. An earlier study, released in February 2016, estimated that about 450 children were born with birth defects or were stillborn during that time.
In May 2013, the FDA put new restrictions on Depakote pregnancy use, contraindicating it for pregnant women, but only when the drug 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.
In 2014, the European Medicines Agency declared it should only be used as a drug of last resort, and then only after expecting mothers were warned of the possible side effects.
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 Depakine.
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.