A study on Sanofi’s epilepsy drug, which was found to cause birth defects, appears to have been concealed by French health authorities.
According to the Associated Press, the French health authorities deny having concealed a study on a drug used to treat epilepsy—the findings of which showed that the drug caused birth defects. Other sources claim that authorities delayed the publication of the study.
Here’s some background information about the study:
- The study began a year ago
- The drug being studied was Sanofi’s anti-convulsion drug Depakine
- The study was performed by national drug agency ANSM and health insurance agency CNAMTS
- The risk of fetus malformation has been known since the 1980s, a Sanofi spokeswoman told Reuters
The study’s “initial findings” are scheduled to officially be presented on August 24 “to parents whose children have been affected by the anti-convulsion drug Depakine,” according to the ministry. The public won’t be hearing about the full study until September, however, at which time an “action plan” will be made.
According to Newshub:
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.
AP adds that, in the same February report there had been about 450 cases in France of “children exposed to the drug during pregnancy who had congenital defects.”
10,000 pregnant women were prescribed Sanofi’s epilepsy drug between 2007 and 2014 “while the potential risks [fetus malformation] for unborn children were known” Le Canard Enchaine weekly reported.
Depakine has also been found to impact “the fetus’ neurological development and could lead to autism or learning difficulties,” according to a Sanofi spokeswoman. All of these potential side effects, the Sanofi spokeswoman said, are in the drug’s documentation.
Depakine is available as a generic and is sold in approximately 120 countries.
Filed Under: Drug Discovery