Risks to the fetus: an anti-epileptic raises more and more concerns

Topiramate, an anti-epileptic, is of growing concern to health authorities. They already called for drastically restricting its use in pregnant women, they come back to the charge in the face of even greater risks than estimated for the baby.

In pregnant women (…), topiramate should not be used in epilepsy unless absolutely necessary“And should not be prescribed under any other pretext, recalled in a press release the National Agency for the Safety of Medicines (ANSM). 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.

Many risks

We know that it is also sometimes given by certain doctors as a slimming agent, but this use is not provided for by the official indications, unlike the United States, where a form of treatment is approved against obesity. 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.

This is not new and the drug agency insists, in fact, on recommendations already in place. It has been known for several years that topiramate increases the risk of malformations – harelip, 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.

The drug authority had therefore already warned in 2019 about the use of topiramate, in a context marked by the Depakine scandal from the Sanofi laboratory, another anti-epileptic implicated in numerous disorders in children exposed during the pregnancy.

Talk to your doctor

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 back on this drug now? This follows the publication of a large Nordic study“, explained to AFP Philippe Vella, specialist in neurological treatments at the ANSM, estimating that a decision by the EMA could take place within a few months.

Published at the end of May in the journal JAMA Neurology, this study, carried out using health data from several million Scandinavian women, shows that the risk of intellectual disability more than triples in children whose mothers took topiramate during pregnancy. pregnancy. The risk of autism disorders is also multiplied, almost by three. “These risks are new; they were hitherto considered as not excluded but not characterized“, specified Philippe Vella.

We therefore need more than everlimit as much as possible the exposure of women of childbearing age and of course pregnant women to these drugs“, he insisted. “If you really have no choice but to prescribe topiramate, you must inform the woman about these risks“. Because that is the whole difficulty of the subject. In some women, only this treatment is effective against epilepsy. It is therefore 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 to discuss the situation with their doctor and, above all, not to decide alone to stop taking topiramate. Because “we are exposed to a resurgence of 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.»

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