Up to 4,100 Children Victims of Sanofi's Epilepsy Drug, Says French Regulator

Published: Apr 21, 2017

Up to 4,100 Children Victims of Sanofi's Epilepsy Drug, Says French Regulator April 20, 2017
By Alex Keown, BioSpace.com Breaking News Staff

PARIS – French health officials said a drug manufactured by Sanofi caused between 2,150 and 4,100 major fetal malformations between the years 1967 and 2016 – numbers that are slightly down from a previously estimated 7,000 children.

The Sanofi drug Valproate, which is known as Depakine and Depakote in France, was prescribed for epilepsy and bipolar disorders. The drug is believed to cause slow neurological development, Reuters reported this morning. The numbers of children negatively affected by the drug are the latest bit of news in an ongoing case for Sanofi.

The National Agency for the Safety of Medicines (France) study said women treated with the drug for bipolar disorder were actually at a lower risk than women treated for epilepsy. However, those women were still twice as likely to give birth to children with major birth defects, the BBC reported this morning, citing the French health agency.

Valproate has been marketed since 1967 and has been one of the mist widely marketed anti-epilepsy treatments. Fetal malformations associated with the drug have included cleft palate and spina bifida. About 40 percent of children whose mothers took the drug while pregnant developed neuro-developmental problems like autism, BioSpace reported last year. The risks associated with the drug were not known when it was first marketed. Although Sanofi has not commented on the latest numbers from France’s drug regulatory agency ANSM, the company has said it has been aware of the risk of fetal malformations as far back as the 1980s. Sanofi said those risks have been well documented in the literature that accompanies the drug. In 2003, Sanofi learned that one of the ingredients in the drug, sodium valproate (Valproic acid), had an impact on fetal neurological development and could lead to autism or other learning problems. The company provided that information to health authorities and the documentation was later updated to include the new findings.

It wasn’t until 2014 that the European Medicines Agency said Valproate should be prescribed only when other treatments have failed and only when patients have been made aware of the risks of taking the drug, especially during pregnancy, Reuters said. Doctors in France are advised not to prescribe valproate to “girls, women of childbearing age and pregnant women,” the BBC reported this morning.

While there has certainly been some criticisms leveled at Sanofi for the malformations, in October 2016 the company said the blame must be shared with health authorities, doctors and pharmacists. In an interview with Reuters last year Pascal Michon, Sanofi’s scientific affairs director, said the company has “always fulfilled its obligations with regard to transparency.”

ANSM said it intends to publish a journal report about the numbers of children impacted in France by their mothers’ taking valproate during pregnancy later this year, Reuters said.

In December, a class action lawsuit was filed against Sanofi in France. As part of the lawsuit, Sanofi was given four months to acknowledge responsibility before a judge is assigned to the case. Four months is nearly at an end and the latest news from ANSM is likely to be included in the case.

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