Sanofi Ready To Accept Blame For Depakote Birth Defects in France, Execs Say

French officials are expected to rule on whether Sanofi Aventis will have to pay compensation for children born with birth defects in that country due to the side effects of Depakote, sold there under the brand name Depakine, and company executives say they will accept whatever ruling comes down. 

According to a recent report by Reuters News, the pharmaceutical company’s scientific affairs director, Pascal Michon, said in an interview that if the Sanofi Aventis is found responsible by French officials, it will accept that responsibility.

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.

A study published this 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, estimated that about 450 children were born with birth defects or were stillborn during that time.

The French parliament is expected to determine responsibility and possible compensation for those born with Depakote-related birth defects before the end of the year, and a judicial review is underway as the result of complaints from French families.

It is unclear how much Sanofi would be expected to pay at this time.

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.

In 2014, the European Medicines Agency declared that 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 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.