Topiramate, an antiepileptic drug also used as a treatment for migraines, should be avoided in women who are pregnant or of childbearing age due to the risk of malformations in the fetus. To limit the risks, ANSM is changing the statute of limitations.
After warning against the use of topiramate in pregnant women and women of childbearing potential on June 29, the Medicines Safety Agency (ANSM) has finally modified the prescription and dispensing conditions (CPD) medicines with topiramate for girls, adolescents, women of childbearing potential and pregnant women.
An antiepileptic drug used to treat migraines and known as Epitomax (Janssen lab), topiramate can cause fetal malformations, as well as risks of neurodevelopmental disorders for the future baby. According to a study published in May 2022 in the journal JAMA neurology, the risks of developing autism spectrum disorders were multiplied by 2.77 after taking topiramate during pregnancy. The risks of intellectual disability have been changed by 3.47.
Also read: Topiramate: This antiepileptic taken during pregnancy increases the risk of autism during pregnancy
Therefore, to limit the risks, changes to the prescribing conditions will take place from 2 November 2022 for the start of treatment with topiramate and from 2 May 2023 for patients on treatment. The ANSM reminds, however, that in women who are pregnant or of childbearing age and who do not have an effective contraceptive means, the treatment remains strongly contraindicated “,except in cases of absolute necessity“, that is to say in case of ineffectiveness of other treatments or intolerances.
What will change with the doctor?
From 2 November it will be the prescription for the start of treatment reserved for neurologists and pediatricians. After complete information on the risks incurred for the unborn child and the need to adopt adequate contraception, the patient must give her consent, through a consent form for treatment (for minors it will be signed by the parents).
If the treatment has already started, it is imperative not to stop without first speaking to a doctor. 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 treatment contract signed. From that date it will be necessary to consult your doctor at least once a year, to reassess the need to continue the treatment annually, in particular in case of desire to become pregnant and to have the consent form signed again. Until May 2, 2023, the renewal of a treatment by any doctor remains possible.
In order to recover the treatment at 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 medical specialist. ANSM has also contacted the EMA to review the European prescribing conditions for topiramate.
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