The National Medicines Safety Agency warns against this antiepileptic, already known to promote malformations in the fetus, and calls to use it only in the event of “absolute necessity” in pregnant women.
Le Monde with AFP
The topiramate, an antiepileptic already known to promote malformations in the fetus when it is taken by a pregnant woman, can also contribute to intellectual disorders, warned The National Medicines Safety Agency (ANSM) Wednesday June 29.
“In pregnant women (…), the topiramate should not be used in epilepsy except in the event of absolute necessity” and should not be prescribed under any other pretext, the ANSM said in a statement.
The topiramate, sold under the Epitomax brand by the Janssen laboratory but also as generic by other manufacturers, is prescribed against epilepsy and migraines. It is also sometimes given by some doctors as weight loss, but this use is not provided for by official indications unlike the United States, where a form of treatment is approved against obesity.
In 2019, the drug authority had already warned of the use of topiramate, in a context marked by the Sanofi laboratory scandal, another antiepileptic involved in numerous disorders in children exposed during pregnancy. Caught by a pregnant woman, the topiramate multiplies the risks of malformations – beaks -of -Lièvre, poor placement of the urethra on the penis – in the unborn child.
new risks
If the ANSM, which asked its European counterpart to reassess the topiramate, communicates again on this medication, it is that 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 from data from several million Scandinavian mothers, shows that the risk of intellectual disability is more than triple in children whose mother has taken topiramate during pregnancy. The risk of autism spectrum disorders is also multiplied, almost by three.
“These risks are new; they were hitherto considered as not excluded but not characterized,” said Philippe Vella, specialist in neurological treatments at ANSM, at the France-France agency. It is therefore more necessary than ever to “limit the exposure of women of childbearing age and of course pregnant women to these drugs as much as possible,” he insisted.
Besides the contraindication to pregnant women, the ANSM also calls on doctors to prescribe the topiramate only in the last use of women who are old enough to have a child and do not take contraception deemed “highly “Effective.
However, the agency also prevents patients that we should not interrupt this treatment suddenly because a resumption of epilepsy attacks can also be dangerous, whether for the mother or the baby to be born.
As such, the drug agency prevents patients under treatment that must be discussed with their doctor and, above all, not decide alone to stop taking topiramate.