The Medicines Agency (ANSM) announced Thursday restrictions on the prescription of topiramate in women, an anti-epileptic at risk for the fetus and subject to patients signing consent.
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.
In June, the ANSM had already recalled that its prescription should be avoided as much as possible in pregnant women and in any woman likely to be expecting a child, even unexpectedly.
Risk of neurodevelopmental disorders
It has been known for several years that topiramate increases the risk of malformations in the fetus.
Recent studies have also highlighted an increased risk of neurodevelopmental disorders for the unborn child.
From November 2, a drug based on topiramate can only be prescribed for the first time to the women concerned by a neurologist or a pediatrician, announced the ANSM.
During this first prescription, they must sign a form attesting that they have been informed of the risks for the unborn child.
In the event of treatment already begun, they will have to make an appointment as soon as possible with a neurologist or a pediatrician by next May, to possibly renew the prescription and sign their agreement.
"For patients treated for epilepsy, it is important not that they suddenly stop the treatment without having spoken to their doctor", warns Philippe Vella, medical director at the ANSM.
Drug contraindicated in the treatment of migraine
On the pharmacist side, for any dispensation of the drug, the presentation of the initial annual prescription of the specialist in neurology or pediatrics as well as the annual co-signed care agreement form, will be compulsory from November 2 to start the treatment, and from November 2 May for patients undergoing treatment.
In view of the latest studies, the ANSM has asked its European counterpart, the European Medicines Agency (EMA), to reassess the conditions for prescribing topiramate.
In pregnant women or women of childbearing potential who do not have an effective method of contraception, topiramate is contraindicated in the treatment of migraine and in the treatment of epilepsy, except in case of absolute necessity, she recalls.
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 anti-epileptic implicated in numerous disorders in children exposed during the pregnancy.
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