French health products agency yanked into legal battle over birth defects caused by Sanofi's Depakine
A probe into Sanofi’s epilepsy drug Depakine has now entangled France’s National Medicines and Health Products Agency (ANSM), which was indicted on Wednesday for “injuries and manslaughter by negligence” related to birth defects and stillborn births caused by the drug.
Sanofi found itself at the center of a manslaughter investigation in August, several months after it was formally charged. The drug, sodium valproate, has been on the market since 1967 for epilepsy and bipolar disorder. It’s on the WHO’s list of “essential medicines,” and is prescribed in over 100 countries. But according to Reuters, France’s social affairs inspection agency estimates 425 to 450 babies exposed to the drug suffered congenital birth defects or were stillborn from 2006 to 2014.
Sanofi allegedly learned of the risk of fetus malformation in the 1980s. And in 2003, the French pharma reportedly became aware that the drug can impact neurological development, with risk of autism or learning difficulties. The EMA re-evaluated the drug in 2014, enforcing recommendations the following year that practitioners not prescribe the treatment to women of childbearing age. But parents of victims say the action came too late.
Nathalie Vivier, a local representative for the victims association APESAC, told the French weekly newspaper La Manche Libre that the ANSM was too slow to issue a warning. “If they had done the job, my kids wouldn’t have had a problem,” she said. APESAC, which was formed in 2011, initiated the criminal investigation against Sanofi.
Marine Martin, president of APESAC, applauded Vivier on Twitter.
— Marine Martin (@_MarineMartin) November 11, 2020
“The ANSM takes the full measure of the suffering of the victims and has worked for several years to limit exposure to valproate in women of childbearing age,” the agency said in a statement, adding that it will “respond to any questioning from Justice in order to make its full and complete contribution to the manifestation of the truth.”
Sanofi has denied the allegations. In August, it told Reuters: “All these elements do not in any way prejudge the responsibility of the company.” Back in 2016, the company told the news wire agency that it would accept any blame attributed by a court.
Depakine earned Sanofi €176 million ($207.7 million) in net sales last year.