Pregnancy: ANSM warns pregnant women about three epilepsy drugs

“Important new data have been published on the drugs topiramate, pregabalin and valproate, all three used in the treatment of epilepsy and respectively in migraine for topiramate, in generalized anxiety disorder and neuropathic pain for pregabalin and in bipolar disorder for valproate derivatives” immediately indicates the ANSM press release.

Risks to the health of the unborn child

Regarding topiramate, the ANSM cites a study published in the journal JAMA. She highlighted a “increase with the use of topiramate of the risk of occurrence of autism spectrum disorders multiplied by 2.77 and intellectual disability multiplied by 3.47 compared to a pregnancy of an epileptic mother without exposure to antiepileptics”.

Asked by Doctissimo, Florent Chapel, co-president of Autism Info Service, believes that pregnant women “must remain vigilant – but without it becoming anxiety-provoking either – about the drugs taken during pregnancy and the potential consequences that this can have on their fetus, and in particular on the brain of the very fragile child during life in womb”.

Moreover, because of these worrying conclusions, the health agency recommends that health professionals “take this risk into account now” for any prescription of the molecule.

The ANSM also recalls that in pregnant women, as well as in women of childbearing age and not using an effective method of contraception, in particular because of the high risk of malformations, topiramate:

• should not be used in epilepsy unless absolutely necessary;
• should not be used in migraine;
• should not be used in any other situation outside of marketing authorization.

Two other molecules in the sights of the health authority

Concerning pregabalin and valproate, other elements encourage the ANSM to remind the vigilance which must surround the prescription of these drugs. In effect, “new data from an observational study have confirmed 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”.

Except in cases of “absolute necessity”, pregabalin should therefore not be given to a pregnant woman and women undergoing treatment should be informed of the risks and take effective contraception.

Potential malformations in the fetus

Finally, valproate is also the subject of an update concerning its recommendations. New elements demonstrate a new risk of “”ocular malformations as well as an overall reassessment of the malformation risk estimated today at 11% for children exposed to valproate and its derivatives during pregnancy (compared to 10.73% previously)”.

In addition, the molecule would also affect fertility in humans. The Health Agency therefore recalls that “valproate and its derivatives are formally contraindicated during pregnancy in the management of bipolar disorders and should not be used in pregnant women with epilepsy, except in the absence of a therapeutic alternative”.