Topiramate, an anti-epileptic already known to promote fetal malformations when taken by a pregnant woman, can also contribute to intellectual disorders, warned the National Medicines Safety Agency (ANSM) Wednesday, June 29.
“In pregnant women (…)topiramate should not be used in epilepsy unless clearly necessary” and should not be prescribed for any other reason, the ANSM said in a statement.
Topiramate, sold under the Epitomax brand by the Janssen laboratory but also as a generic by other manufacturers, is prescribed against epileptic seizures and migraines. It is also sometimes given by some doctors as a weight-loss, but this use is not provided for by the official indications unlike in the United States, where a form of treatment is approved against obesity.
In 2019, the drug authority had already warned about the use of topiramate, in a context marked by the Depakine scandal from the Sanofi laboratory, another antiepileptic implicated in numerous disorders in children exposed during pregnancy. . Taken by a pregnant woman, topiramate increases the risk of malformations – cleft lip, poor placement of the urethra on the penis – in the unborn child.
If the ANSM, which asked its European counterpart to re-evaluate topiramate, communicates again on this drug, it is because new risks have been highlighted for the unborn child.
Published at the end of May in the journal JAMA Neurology, a study, carried out a posteriori using data from several million Scandinavian mothers, shows that the risk of intellectual disability more than triples in children whose mothers took topiramate during pregnancy. The risk of autism spectrum disorders is also multiplied, almost threefold.
“These risks are new; they were hitherto considered as not excluded but not characterized”, explained Philippe Vella, specialist in neurological treatments at ANSM, at Agence France-France. We therefore need more than ever “limit as much as possible the exposure of women of childbearing age and of course pregnant women to these drugs”he insisted.
In addition to the contraindication for pregnant women, the ANSM also calls on doctors to prescribe topiramate only as a last resort to women who are of childbearing age and do not take contraception deemed “highly” efficient.
However, the agency also warns patients that this treatment should not be stopped suddenly because a resumption of epileptic seizures can also be dangerous, whether for the mother or the unborn baby.
As such, the drug agency warns patients undergoing treatment to discuss the situation with their doctor and, above all, not to decide alone to stop taking topiramate.