Topiramate, an antiepileptic drug already known to promote fetal birth defects when taken by a pregnant woman, may also contribute to mental disorders, the National Medicines Safety Agency (ANSM) warned Wednesday, June 29 .
“For 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, which is sold under the Epitomax brand by Labor Janssen but also as a generic drug by other manufacturers, is prescribed for epileptic seizures and migraines. It is also sometimes given by some doctors for weight loss, but this use is not covered by official indications, unlike in the United States, where an anti-obesity treatment is approved.
Back in 2019, in a context marked by the Sanofi laboratory’s Depakine scandal, the drug agency had warned against the use of topiramate, another antiepileptic drug linked to numerous conditions in children exposed during pregnancy . . Taken by a pregnant woman, topiramate increases the risk of birth defects – cleft lips, poor fitting of the urethra to the penis – in the unborn child.
If the ANSM, which had asked its European counterpart for a re-evaluation of topiramate, is again communicating about this drug, it is because new risks for the unborn child have been identified.
Appears in the magazine at the end of May JAMA Neurology, a retrospective study using data from several million Scandinavian mothers, shows that the risk of developing intellectual disability in children whose mothers took topiramate during pregnancy more than tripled. The risk of autism spectrum disorders is also multiplied, almost tripling.
“These risks are new; they were previously considered not to be excluded, but not characterized.”, explained Philippe Vella, specialist in neurological treatments at ANSM, from the Agence France-France. So we need it more than ever “Minimize exposure of women of childbearing potential and naturally pregnant women to these drugs”he insisted.
In addition to the contraindication for pregnant women, the ANSM also urges physicians to prescribe topiramate only as a last resort to women who are of childbearing potential and are not considered a contraceptive “maximum” efficient.
However, the agency also warns patients not to stop this treatment suddenly, as recurrence of epileptic seizures can also be dangerous, either for the mother or the unborn child.
Therefore, the drug agency warns patients under treatment to discuss the situation with their doctor and, above all, not to decide on their own to stop taking topiramate.