After having warned against the use of topiramate in pregnant women and of childbearing age on June 29, the Medicines Safety Agency (ANSM) finally modified the prescribing and dispensing conditions (CPD) topiramate medicines for girls, adolescents, women of childbearing age and pregnant women.
An antiepileptic drug used to treat migraines and known as Epitomax (Janssen laboratory), topiramate can cause fetal malformations, as well as risks of neurodevelopmental disorders for the future child. According to a study published in May 2022 in the journal JAMA Neurology, the risks of occurrence of autism spectrum disorders were multiplied by 2.77 after taking topiramate during pregnancy. The risks of intellectual disability were modified by 3.47.
Read also: Topiramate: this antiepileptic taken during pregnancy increases the risk of autism during pregnancy
Thus, to limit the risks, changes to the prescribing conditions will take place from November 2, 2022 for initiations of treatment with topiramate and from May 2, 2023 for patients undergoing treatment. The ANSM nevertheless recalls that in pregnant women or women of childbearing age and who do not have an effective means of contraception, the treatment remains strongly contraindicated, “except in cases of absolute necessity“, that is to say in the event of ineffectiveness of other treatments or intolerance.
What will change with the doctor?
From November 2, the prescription for the start of treatment will be reserved for neurologists and pediatricians. After complete information of the risks incurred for the unborn child and the need to take adequate contraception, the patient must give her consent, via a care consent form (for minors, it will be signed by the parents).
If the treatment has already started, it is imperative not to stop it without having spoken to a doctor beforehand. However, to renew it, the rules change. From now on, the patient will have to make an appointment with a neurologist or a pediatrician no later than May 2, 2023 so that the doctor can renew the prescription and have the care agreement signed. From this date, it will be necessary to consult your healthcare professional at least once a year, to re-evaluate the need to continue the treatment annually, in particular in the event of a desire for pregnancy and to have the consent form signed again. Until May 2, 2023, the renewal of a treatment remains possible by any doctor.
In order to recover the treatment in the pharmacy, it will now be necessary to present the annual prescription from the neurologist or pediatrician, as well as the care agreement form signed by the patient and her health specialist. The ANSM also contacted the EMA to review the prescription conditions for topiramate at European level.
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