French pharmacist Sanofi said Tuesday that he was being investigated by Depakine, a drug for epilepsy that caused birth dysfunctions and a slow neurological development when taken during pregnancy.
The Paris prosecutor had already initiated a preliminary investigation into the authorization and commercialization of Depakine in 2016, after the French social affairs inspection agency IGAS criticized the slow response of the health authorities and Sanofi to the risks related to the drug and its derivatives.
Sanofi said in a statement that the accusation, which may or may not lead to a trial, will allow him to defend himself and “prove that he has always fulfilled his duty to inform and be transparent.”
Sanofi, who has repeatedly said he did not intend to compensate or participate in a state-backed compensation mechanism for Depakine, added that he would continue to “cooperate fully with the judicial authorities,” and was “sure” about the outcome.
Such legal cases can take years and do not necessarily result in significant amounts of compensation in France compared to other jurisdictions such as the United States.
In one of the largest pharmaceutical scandals in France, privately owned Servier has paid 152.5 million euros ($ 169 million) to patients.
Sodium valproate, the active molecule in Depakine, has been on the market since 1967 to treat epilepsy and bipolar disorder. It appears on the list of “essential medicines” of the World Health Organization (WHO).
Depakine, who lost his patent in 1998, is prescribed in more than 100 countries. It is also sold under the names of Depakote and Epilim.
IGAS estimated that between 2006 and 2014, 425 to 450 babies suffered birth defects or were born dead after exposure to Depakine.
Marine Martin, president of the APESAC victims association, said on Twitter that she was “extremely pleased to see that the criminal process that began in 2016 reached an important threshold.”
“Sanofi will have to deal with the tens of thousands of poisoned victims, of which more than a hundred died.”
The French firm realized the risk of malformation of the fetus in the 1980s and then, around 2003, the impact of the drug on the neurological development of the fetus, with risk of autism or learning difficulties.
The US Food and Drug Administration. UU. He warned in 2013 that valproate should not be taken during pregnancy.