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Sanofi Aventis may face manslaughter charges in France, the drug manufacturer’s home country, over deadly birth defects linked to Depakine; an epilepsy drug known in the U.S. as Depakote.
The charges were first reported in the French newspaper Le Monde this week, which indicates the company confirmed French authorities have launched a formal investigation, which, in France, means a judge believes there’s enough evidence to pursue a case, similar to the role of a Grand Jury in the U.S.
Depakine and Depakote both contain the same active ingredient, valproic acid, and are prescribed for treatment of seizures and bipolar disorder, as well as migraine headaches. Since the U.S. version was approved by the FDA more than three decades ago, the drug has been linked to a number of serious health concerns for unborn children when used by pregnant women.
In February, Sanofi indicated it already faced charges in France over downplaying the Depakine’s birth defects risks. However, the new charges include four allegations of manslaughter in connection to the deaths of four babies whose mothers took the epilepsy drug.
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.
In the U.S., the drug is distributed by AbbVie and Abbott Laboratories. In France, it is distributed by Sanofi.
Before the drug’s patent expired in 2007, Depakote was a blockbuster drug generating about $1.5 billion in annual sales.