Topiramate, an antiepileptic, is of growing concern to health authorities. They already called for drastically restricting its use in pregnant women, and the National Medicines Safety Agency (ANSM) has returned to the charge facing even greater risks than estimated for the baby.
“In pregnant women (…), topiramate should not be used in epilepsy except in cases of absolute necessity” and should not be prescribed under any other pretext, she recalled in a press release. Why does the ANSM ask to avoid its prescription as much as possible in pregnant women and in any woman likely to be expecting a child, even unexpectedly? Because, for the unborn baby, this treatment presents many risks.
- Under what conditions is the drug prescribed?
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 official indications, unlike the United States, where a form of treatment is approved against obesity.
This is not new and the drug agency insists, in fact, on recommendations already in place. We have known for several years that topiramate increases the risk of malformations – cleft lip, poor placement of the urethra on the penis – in the unborn child. It also puts him at risk of having a very low birth weight.
A new study, published at the end of May in the journal JAMA Neurology, and carried out using health data from several million Scandinavian women, shows that the risk of intellectual disability more than triples in a child whose mother took topiramate during of pregnancy. The risk of autism disorders is also almost tripled.
The drug authority had already warned in 2019 about the use of topiramate, in a context marked by the Depakine scandal from the Sanofi laboratory, another antiepileptic drug implicated in numerous disorders in children exposed during pregnancy.
- Why this new alert from the health authorities?
The ANSM, for the time being, therefore essentially only insists again on these precautions. However, with a novelty: it has asked its European counterpart, the European Medicines Agency (EMA), to reassess the conditions for prescribing topiramate.
“Why are we coming back to this drug now? It follows the publication [de la] large Nordic study”, explained Philippe Vella, specialist in neurological treatments at the ANSM, estimating that a decision by the EMA could take place within a few months. “These risks are new; they were previously considered as non-excluded but not characterized,” he said.
- What alternatives for women with epilepsy?
This is the whole difficulty of the subject. In some women, only this treatment is effective against epilepsy. It is up to their doctors to assess whether the risks represented by the seizures are high enough to compensate for those that the treatment poses to the unborn child.
As such, the drug agency warns patients undergoing treatment that they must discuss the situation with their doctor and, above all, not decide alone to stop taking topiramate. Because “we expose ourselves to an upsurge in crises, even to more severe crises, noted Philippe Vella. It is a risk for the mother herself and it is a risk for the child.”