French authorities have spent more than three years investigating whether Sanofi downplayed the danger birth defects linked to its valproate-based anti-epilepsy med Depakine. Now, that probe has materialized into actual charges––but it might not land Sanofi in the courtroom.
Sanofi faces charges in a French investigation into whether it failed to adequately warn pregnant patients of the risk of using its Depakine drug, the company said in an emailed statement. The drug shares an active ingredient with Depakote and Stavzor.
Unlike in the U.S. legal system, those charges in France don't necessarily mean Sanofi will face a courtroom. Prosecutors have yet to determine whether they will take the case before a judge.
With the charges laid out, Sanofi said it intends to work with authorities and called the treatment of pregnant women with epilepsy a "complex issue."
Valproate has been the subject of scrutiny in France since it was tied to severe birth defects. In 2011, the FDA linked Abbott Laboratories' Depakote with cognitive deficiencies in infants born to pregnant women who took the drug.
A year later, Abbott was forced to hand over a whopping $1.6 billion settlement to end an investigation into its Depakote marketing.
Abbott pleaded guilty to a single misdemeanor violation of the Food, Drug, and Cosmetics Act, acknowledging that it fielded a sales force specifically trained to market Depakote in nursing homes for off-label use in elderly dementia patients.
The company also admitted that it promoted Depakote as an add-on therapy for schizophrenia, even after trials showed the drug offered no added benefit. The company waited two years to tell its sales force about the disappointing trial data and another two years before publishing the results, the Justice Department said.
Sanofi's investigation began in September 2016 following a patient lawsuit against the drugmaker, France24 reported.
The charges follow two French government agencies' determinations that Sanofi had not done enough to warn patients taking Depakine about the data linking it to birth defects––including studies that found higher risks of congenital malformations and autism in affected infants.
In early 2019, Sanofi's valproate drugs were at the center of a global shortage after France Nature Environnement complained emissions from the drugmaker's Mourenx, France, plant, including cancer-causing bromopropane, were polluting the area. The drugmaker said the issues cited in the complaint had been resolved.