Sanofi will accept any blame attributed to it by a court over the harmful effects of its epilepsy treatment depakine on unborn babies, although it has so far made no financial provision for doing so, the French drug company’s scientific affairs director says in a Reuters Health report.
The company has so far made no financial provisions for compensating victims and families affected by stillbirth, malformations and slow neurological development, believing that it has always fulfilled its obligations with regard to transparency, Pascal Michon is quoted in the report as saying. “We expect the justice system to do its work,” he said. “Only the courts can establish the exact responsibilities in this complex case. If we are found to be responsible then we will assume that responsibility just as we always have.”
Depakine is a branded form of the medication known as valproate which treats epilepsy and bipolar disorder. It has been on the market since 1967.
Evidence grew toward the end of the 20th century that the drug could cause deformities in unborn children, but it was not until 2014 that the European Medicines Agency decreed it should be prescribed only when other treatments had failed, and only with accompanying evidence that patients had been informed of the risks during pregnancy.
“We know with hindsight the neuro-developmental risks linked to valproate. The risks are known today and they were not known in the 1990s,” Michon said.
French social affairs inspection agency IGAS criticised the slow response of French health authorities and Sanofi with regard to the risks related to Depakine and its derivatives.
IGAS estimates that between 2006, when the medicine started carrying a health warning, and 2014, when the rules were further tightened, some 425 to 450 babies suffered congenital birth defects or were still-born following exposure to the drug.
The report says the French parliament is to vote later this year on a compensation mechanism for victims of the drug’s side effects and a judicial investigation was launched last year after a group of families lodged a legal complaint. French Health Minister Marisol Touraine has said the government will approach other parties to pay their dues should the courts establish blame.
Depakine is also prescribed under other brand names and in more than 100 other countries. It went off patent in 1998. Michon, a qualified doctor, would not offer any estimate of the potential cost to the company.Reuters Health report