For years, Sanofi has faced a French probe into birth defects tied to epilepsy medicine Depakine, and now the investigation is moving forward on manslaughter charges.
Authorities in France are investigating those charges because of safety risks for babies when the medicine, known generically as valproate, is taken by pregnant women, Reuters reported.
Still, it’s unclear whether the drugmaker will face a trial. Prosecutors can still decide not to take the case if they determine the evidence is insufficient, according to reports.
France’s Le Monde newspaper first reported the charges, which Sanofi confirmed in a statement to FiercePharma. Sanofi will challenge the indictment, a spokeswoman said. Earlier this year, authorities charged the company with “aggravated deception” and “involuntary injuries” associated with Depakine.
“Sanofi Aventis France has complied with its disclosure obligations and is challenging the merits of these lawsuits,” the spokeswoman added.
Approved since 1967, Depakine treats epilepsy, migraines and bipolar disorder. The drug lost its patent in 1998 and is still prescribed in more than 100 countries, according to Reuters, including the U.S., where it was launched under the brand name Depakote.
Sanofi has been under investigation for four years over risks from the medicine. An agency of the French government concluded that 425 to 450 babies suffered birth defects or were stillborn between 2006 and 2014 after their mothers took Depakine, Reuters reported.