Too slow to warn: Sanofi indicted over old anti-epileptic drug tied to birth defects
Sanofi has been formally charged over Depakine — a decades-old therapy for epilepsy that causes birth defects and impedes neurological development when taken during pregnancy.
Evidence that the compound — sodium valproate — was associated with neurodevelopmental risks emerged in the latter half of the 20th century. In 2014, the EMA re-evaluated the drug, and a year later recommendations that practitioners should no longer prescribe the treatment for women of childbearing age or pregnant women were enforced.
In 2015, the French social affairs inspection agency (IGAS) chided French health authorities and Sanofi over their response to the risks related to the drug and its derivatives. Soon after, the French prosecutor kicked off a preliminary investigation into the approval and sale of Depakine in October 2016, Reuters reported.
The compound — which is on the WHO list of “essential medicines” — has been on the market since 1967 to treat epilepsy and bipolar disorder. Sanofi learned of the risk of fetus malformation in the 1980s. In 2003, the company became aware of the drug’s impact on the neurological development of the fetus, with a risk of autism or learning difficulties, according to the wire agency.
“It’s finally a great victory!” tweeted Marine Martin, president of the Association for the assistance of parents of children suffering from anti-convulsant syndrome (APESAC), which was set up in 2011. “My determination paid off, we will have our big criminal trial !!!”
Ca y est enfin GRANDE VICTOIRE ✌️ SANOFI MIS EN EXAMEN au PENAL ⛓dans le dossier de la DEPAKINE 💊
Ma détermination a payé on aura notre grand procès pénal !!!
Communiqué de Presse pic.twitter.com/PtfSlzdNYw
— Marine Martin (@_MarineMartin) February 3, 2020
The criminal investigation was initiated by APESAC, and forms of part of the process of the pending criminal investigation on Depakine before the Judicial Tribunal of Paris, a Sanofi spokesperson told Endpoints News.
“This (indictment) status will allow us to assert all of our means of defence and demonstrate that the company has complied with its notification obligation,” the spokesperson said.
IGAS has estimated that between 425 to 450 babies suffered congenital birth defects or were stillborn following exposure to Depakine from 2006 to 2014, according to estimates cited by Reuters.
After parents of sufferers criticized the French state and Sanofi for being too slow to warn about the side effects of the drug — in 2017, a compensation scheme for victims was set up. Roughly 6.5 million euros has been provided in compensation to 31 victims, although nearly 2,000 claims have been filed, according to the French media group franceinfo.
Sanofi is not participating in this fund, the spokesperson told Endpoints.
In a 2016 interview with Reuters, Sanofi said it would accept any blame attributed by a court over the drug.
On Tuesday, Sanofi in a statement that it will “prove it has always complied with its duty to inform and been transparent.”