The active component of the drug, sodium valproate, has been on the market for epilepsy and bipolar disorder since 1967.
A Paris-based prosecutor has initiated an investigation into Sanofi over the company’s drug Depakine. The active component of the drug, sodium valproate, has been on the market for epilepsy and bipolar disorder since 1967. The drug is listed on the World Health Organization (WHO)’s list of “essential medicines.”
However, the French social affairs inspection agency IGAS is investigating the company and French health authorities’ slow response to questions over the drug’s risks. The agency alleges that between 2006 and 2014, 425 to 450 babies were either stillborn or had congenital birth defects after exposure to Depakine.
Marine Martin, president of APESAC, a victims association, tweeted that she was “extremely satisfied to see the criminal proceedings she launched in 2016 reach an important threshold. Sanofi will have to deal with the tens of thousands of poisoned victims, out of which more than a hundred died.”
Reportedly, Sanofi became aware of the risk of fetal malformation in the 1980s. Then, in 2003, there were indications of the drug’s effect on fetal neurological development, with increased risk of autism and learning problems.
In January 2019, the company said it would not participate in any Depakine compensation, saying it would continue to “fully cooperate with the judicial authorities,” and was “confident” over the investigation.
Sanofi states that the indictment, which could lead to a trial, gives it the chance to defend itself and to “prove it has always complied with its duty to inform and been transparent.”
WTVB notes that these types of legal cases can take years and, unlike in the United States, do not necessarily result in large financial settlements in France. One of the country’s biggest pharmaceutical lawsuits involved Servier has paid out $169 million to patients.
The patent for Depakine ended in 1998. It is prescribed in more than 100 countries, where it is also marketed as Depakote and Epilim.
In 2013, the U.S. Food and Drug Administration (FDA) warned that valproate should not be taken during pregnancy.
It was announced in early January that about a dozen parents in Switzerland had filed a civil lawsuit over Depakine against Sanofi. They argue that the company did not warn them about the risks to fetuses. SWI wrote, “Scientists have established that the sodium valproate contained in the drug creates psychomotor, cognitive and mental development disorders in 30 to 40% of cases. The Swiss expecting mothers were not made aware of these dangers. A warning from the agency for therapeutic products, Swissmedic, came too late.”
Reportedly, 39 children in Switzerland have been born with brain damage linked to Depakine, according to a Swiss government report.
Thierry Buclin, a professor of clinical pharmacology at the University Hospital of Lausanne believes the actual number is higher, saying the government study is incomplete and does not take into consideration the transgenerational effect of the drug, which has been noted in several research studies.
The drug was approved in Switzerland in the 1970s, but side effects over fetal development issues was not mentioned in package warnings until 2015. In France, as many as 6,500 children have been negatively affected by the drug.
