PARIS (Reuters) - More than 14,000 pregnant women in France took Sanofi’s anti-epilepsy drug Depakine between 2007 and 2014 even though the risk of fetus malformation was known, according to a study released by France on Wednesday.
Health Minister Marisol Touraine said in a statement that a second part of the study, yet to be released, would focus on the impact on children whose mothers took the drug.
Its active ingredient is sodium valproate and it has been sold under different brand names. It can increase the risk of autism, arrested development and deformation of facial features.
Touraine said parliament would vote on a compensation mechanism for victims by the end of this year.
Parents of victims say Sanofi and the French state have been too slow in warning about the side effects of the drug. Victims association APESAC estimates that Depakine could have affected more than 50,000 people since it was first sold in 1967.
“It is a sanitary scandal at the Sanofi laboratories with state complicity,” APESAC President Marine Martin told Reuters.
Sanofi said in a statement it would study the results of the report but it had had no access to the information so far.
It said between 2007 and 2014 the information for doctors and patients indicated that the drug was not suitable for pregnant women because of the risk of malformation of the fetus and slower neurological development.
Touraine said a pictogram would be added to the drug’s packaging within the next six months to warn clearly about the danger to pregnant women.
In a report published in February, French social affairs inspection agency IGAS criticized the slow response of French health authorities and Sanofi with regard to the risks related to Depakine and its derivatives.
IGAS estimates that between 2006 and 2014 some 425 to 450 babies suffered congenital birth defects or were still born following exposure to the drug.
It said the drug has been on the market since 1967 and the risk of fetus malformation was established in the early 1980s. Despite those risks, the drug continued to be prescribed because of its effectiveness against epileptic seizures and bipolar disorder.
In October, the Paris prosecutor launched a preliminary investigation into the authorization and marketing of the drug.
Reporting by Marine Pennetier and Geert De Clercq; editing by David Clarke