Sanofi charged in birth defects case in France

pharmafile | February 4, 2020 | News story | Manufacturing and Production Sanofi, Sanofi Birth Defects, Sanofi France 

Sanofi has been charged with failure to adequately warn patients about their anti-epilepsy drug which has been linked to birth defects.

The charges follow a three-year probe into the company, which was launched in September 2016 following legal action by victims and their families as they sought to determine whether Sanofi misled doctors and patients about their drug valproate. It was marketed around the world with the names Depakine, Depakote, Stavzor among other trade names.

Studies found that the babies of women who took the medicine while pregnant women had a 10% elevated risk for congenital malformations. The risk for learning difficulties and autism reached as high as 40 percent.

Sano said in a its statement that it welcomed the advancement of the case as “it will be the occasion to demonstrate that it respected its obligation to inform” patients and was transparent about the drug.

The French legal system means the charges do not automatically mean the case will reach a courtroom as prosecutors may not decide to move to a trial.

Conor Kavanagh


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