PARIS (Reuters) - French regulator ANSM said epilepsy drug valproate would face new restrictions across the European Union to protect pregnant women or of child-bearing age from exposing their babies to possible malformations and developmental problems.
“Valproate is forbidden during pregnancy and should no longer be prescribed to girls, teenagers and women of child-bearing age unless exceptional circumstances,” France’s Agence Nationale de Securite du Medicament said in a statement.
The statement echoed a decision by the European Commission made public earlier this year by the European Medicines Agency.
“The new measures include a ban on the use of such medicines for migraine or bipolar disorder during pregnancy and a ban on treating epilepsy during pregnancy unless there is no other effective treatment available,” the EMA said of valproate.
“Further, the medicines must not be used in any woman or girl able to have children unless the conditions of a new pregnancy prevention program are met.”
Prescribed globally for epilepsy and bipolar disorders - and in some cases migraines - valproate is included in the World’s Health Organization list of essential medicines.
But the drug, manufactured by French drugmaker Sanofi and sold under brands such as Depakine, Depakote and Epilim, is also known to have caused birth malfunctions and slow neurological development after being taken during pregnancy.
Earlier this year, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency recommended measures to avoid valproate exposure in pregnancy but did not call for a ban.
It said that the outer packaging of all valproate medicines must include a visual warning about the risks in pregnancy.
“The European Commission decision endorsed the PRAC recommendations. Sanofi will follow theses recommendations to revise the product information for epilepsy and bipolar disorder, and will do so across Europe and worldwide” a spokesman for the company said in an emailed statement.
Reporting by Matthias Blamont; Editing by Matthew Mpoke Bigg