A study published at the end of May in the journal JAMA Neurology confirms the dangerousness of topiramate for pregnant women with epilepsy. This drug was already known to increase the risk of malformations in infants.
In a publication dated June 29, the National Agency for the Safety of Medicines and Health Products (ANSM) warned against topiramate, a molecule prescribed in France for people with epilepsy, but also used to fight against migraines. According to the results of a study published at the end of May, the drug increases by nearly 3 the risk of autism in children when taken by the mother during pregnancy.
“A study published in JAMA Neurology showed an increased risk with the use of topiramate of the occurrence of autism spectrum disorders multiplied by 2.77 and intellectual disability multiplied by 3.47 compared to a pregnancy. an epileptic mother without exposure to antiepileptics”, writes the ANSM.
An increase also in cases of intellectual disability
This is not the first time that topimarate has been singled out. It is already presented as teratogenic, that is to say dangerous in pregnant women. It triples the risk of major malformations, including cleft lips and palate, damage to the genitals and reduction in the size of the head and brain. It also increases the risk of low birth weight in newborns exposed in utero.
The new study published on May 31 now points to the neurodevelopmental risks posed by the drug. It concerns a register of data collected between 1996 and 2017 in five countries: Sweden, Finland, Norway, Denmark and Iceland.
A total of 4,494,926 births were scrutinized. Within the latter, children born to mothers with epilepsy but not following treatment for epilepsy were 1.5% to be diagnosed with an autism spectrum disorder after their birth. A share that rises to 4.3% for children whose mothers took topiramate during their pregnancy.
Based on this study, the ANSM thus evokes a risk of occurrence of autism spectrum disorders multiplied by 2.77 in a pregnant woman taking topiramate. But another equally worrying phenomenon noted in this new study, the increase in cases of intellectual disability in children when taking topiramate during pregnancy. It is multiplied by 3.47.
Recommendations for women and doctors
Faced with this observation, and “pending the conclusions of this evaluation”, the ANSM draws up a list of information for women with epilepsy and health professionals.
For pregnant women or who think they may be, it is advisable to immediately consult their doctor, who will assess the need to continue treatment. The latter will take into account the risks to which the child is exposed, but also the risks that uncontrolled epilepsy could pose to the pregnant woman during her pregnancy.
For women who are pregnant or who think they are and taking topiramate for the treatment of migraine, the ANSM indicates that the doctor “will proceed to stop the treatment and may prescribe another medication”.
Similarly, women of childbearing age and suffering from epilepsy are recommended to use “highly effective contraception”. Topiramate can make birth control pills less effective.
It is nevertheless important to specify that pregnant women taking topiramate are strictly advised not to suddenly stop their treatment, without speaking to their doctor first. Such an approach would risk increasing epileptic seizures, a dangerous situation both for pregnant women and for their unborn child.
32,000 women “on” topiramate
Finally, the ANSM recommends that doctors not prescribe topimarate in pregnant patients and patients with migraine, and for those with epilepsy, to measure whether the benefit of this treatment for the mother clearly outweighs the risks. ‘he poses for the future child. According to information from Parisian32,000 women of childbearing age currently treat their epilepsy or migraine with topiramate in France.
The ANSM has published a list of the various high-risk drugs on its website. In France, topiramate is notably prescribed under the name of Epitomax.
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