Depakine is not the only antiepileptic drug that presents a risk of malformations for children exposed in their mothers' womb, even though this is the most important, according to a report from the Medicines Agency that paints a scale of risks for 21 antiepileptics.
This analysis confirms that Depakine and its derivatives are the most at risk. But this risk of malformations is "high" for five drugs, which multiplies it by three compared to what is observed in the untreated population.
"The existence of a risk with these antiepileptics was known, but not quantified by one report to others," says Dr. Philippe Vella of the ANSM. "With valproate (Depakine and derivatives) the risk is multiplied by five," he recalls.
Risks of oral malformations
In particular, it is topiramate (Epitomax and its generics) which leads to an increased risk of oral malformations such as hare beak and an abnormality in the penis with abnormally positioned urethral orifice (hypospadias). . This drug prescribed to women of childbearing age (about 30,000 in 2015) and also outside the official indications (especially for weight loss or for bipolar disorders), also presents a potential risk of neuro-developmental disorders.
The other four are phenobarbital, primidone, carbamazepine and phenytoin.
An independent committee of experts is to meet
Up to 30,000 children may have been affected by developmental disorders (autistic, mental retardation, language difficulties or delays ...) after being exposed to valproate / depakine in their mother's womb for the last fifty years, according to the first official estimate issued by the ANSM and the Health Insurance in June 2018. Added to this was an estimate of 2,000 to 4,000 victims of malformations.
In addition, the ANSM "calls for vigilance" on the use of pregabalin (Lyrica and generics) given the potential malformative risk and its important prescription in France (150,000 women in childbearing years).
The ANSM will convene a committee of independent experts (CSST) on May 14 to propose additional risk reduction measures related to in utero exposure to antiepileptic drugs. The auditions will be broadcast live on the web. In addition, the health agency has set up, in conjunction with the Association of Parents of Children with Anti-Convulsive Syndrome and the French Network of Regional Pharmacovigilance Centers, a complementary form to better report cases. exposure of children to antiepileptic drugs during pregnancy (report-sante.gouv.fr). She advises, among other things, women to consult their doctor without delay in case of pregnancy to know if it is necessary to modify the treatment and not to stop the treatment without consulting.