the topiramate, an antiepileptic drug also used to treat migraines, should be avoided in pregnant women or women of childbearing age, the ANSM warns on June 29. In question ? If it was already known that this treatment could generate malformations in the fetus, it could also increase the risk of developing autism spectrum disorders (ASD).
According to one study published on May 31, 2022 in the journal JAMA Neurologythe risks of occurrence of ASD were increased 2.77 times after taking topiramate during pregnancy. The cases of intellectual disability were multiplied by 3.47 compared to the pregnancy of an epileptic woman without exposure to treatment. The data was collected between 1996 and 2017, i.e. a total follow-up of nearly 4.5 million mothers and children. To achieve these results, the study included 24,285 children exposed in utero to at least one epileptic drug and followed them on average until their 8e year.
“We ask healthcare professionals and patients to take this risk into account from now on when prescribing topiramate in a woman of childbearing age and in the event of pregnancy.indicates the communicated from the ANSM.
A high risk of microcephaly or genital damage
Topiramate is a teratogenic drug, already known to put fetuses at serious risk of major deformities, including clefts in the lips and palate, damage to the genitals or even a reduction in the size of the head and brain (microcephaly). The treatment also exposes you to a risk of low birth weight.
Faced with this new risk for the foetus, the ANSM recalls good practices for pregnant women, of childbearing age or not taking contraception.highly effective”. Topiramate absolutely must not :
- Be used for epilepsy unless absolutely necessary;
- Be used for migraine;
- Be used in any other situation outside the marketing authorization.
Be careful though, if you are pregnant and being treated for epilepsy, do not stop your treatment without talking to your doctor. “Suddenly stopping treatment can lead to a resurgence of seizures, which could have serious consequences for you and your child.alerts the ANSM.
The ANSM adds that new data concern two other anti-epileptic drugs which should not be used during pregnancy:
- Pregabalinalso used in generalized anxiety disorder and neuropathic pain. These data confirm the risk of malformation linked to exposure to pregabalin during pregnancy: this risk is multiplied by almost 1.5 compared to the population not exposed to this drug. Pregabalin should not be used during pregnancy unless clearly necessary.
- Valproate, also prescribed for bipolar disorder. The ANSM recalls that valproate and its derivatives are formally contraindicated during pregnancy in the treatment of bipolar disorders and should not be used in pregnant women with epilepsy, except in the absence of a therapeutic alternative.
Sources:
- Topiramate: risk of neurodevelopmental disorders in children exposed in utero and reminder of the rules for use in women, ANSM, June 29, 2022
- Association of Prenatal Exposure to Antiseizure Medication With Risk of Autism and Intellectual Disability, JAMA NeurologyMay 31, 2022
Read also:
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- Depakine case: Sanofi held responsible for a lack of vigilance and information on the risks
