The French National Agency for Drug Safety has decided not to prescribe drugs containing valproate (Dépakine) for pregnant women, adolescents and women who are still of childbearing age.
The drug is prescribed to treat epilepsy and convulsions caused by bipolar disorder, but is already responsible for abnormalities and neurological disorders in children exposed during pregnancy, according to one study.
According to a study published a year ago, between 2,150 and 4,100 children in the womb are likely to have been exposed to valproates and derivatives during the period from 1967 to 2016 and are now suffering from at least one major congenital malformation.
This estimate does not take into account neurological behavioral disorders or minor congenital malformations, Le Figaro reported.
For women and girls who are currently using valproates, the French agency warns them against stopping or replacing them with another treatment without consulting a doctor. The agency recommended this group of women, "Make an appointment with your specialist doctor and you will study all the solutions to stop your treatment with palproates."
The European Commission followed France's decision to ban the drug on pregnant women, and called for further action in this regard.
However, if the alternatives to valproate are ineffective or if the patient is allergic to those alternatives, this drug may be described in very exceptional circumstances.