2023-09-11 14:30:59
At the request of the ANSM, the Pharmacovigilance Committee (PRAC) of the European Medicines Agency (EMA) assessed new data on the risk of neurodevelopmental disorders during exposure to topiramate during pregnancy. At the end of this evaluation, the PRAC recommends new measures to limit the use of topiramate during pregnancy.
These medications were already contraindicated for migraine in pregnant women and in women of childbearing age not using a highly effective contraceptive method.
From now on, these medications can also no longer be used in the treatment of epilepsy in:
– girls, adolescents, women of childbearing age not using effective methods of contraception;
– and pregnant women (except exceptionally in the absence of a therapeutic alternative and only following informing the patient).
The prescribing and dispensing conditions already implemented in France (annual initial prescription established by a neurologist or pediatrician, annual signature of a care agreement and dispensation conditional on the presentation of these 2 documents) remain in force. In France, topiramate (Epitomax and its generics) is indicated for the treatment of epilepsy in children and adults, as monotherapy or in combination with other medications, as well as for the prevention of migraine in the adult.
Context reminder
Following the publication of the study results published on May 31, 2022 in JAMA Neurol on the risk of neurodevelopmental disorders in children exposed to antiepileptic drugs during pregnancy and highlighting an increase in risk of 2 to 3 for topiramate, the ANSM initially, in June 2022, asked the PRAC to the EMA to confirm this safety signal, then in August 2022 to reassess the benefit/risk balance of topiramate for all its indications.
Pending the conclusions of the PRAC, the ANSM has modified the conditions for prescribing and dispensing these medications from November 2022 for treatment initiations and at the latest in May 2023 for treatment renewals, so as to that, for girls, adolescents, women of childbearing age and pregnant women in France:
The prescription of topiramate (Epitomax and generics) is carried out annually by a neurologist or pediatrician. Renewal is possible by any doctor in the meantime. The patient and the neurologist or pediatrician must sign a care agreement every year, establishing that the patient has been informed of the risks of the treatment for her unborn child in the event of pregnancy.
Dispensing in pharmacies is only possible upon presentation : A prescription drawn up by a neurologist or pediatrician less than one year old; The annual care agreement form signed by the patient (or by her legal representative), as well as by the neurologist or pediatrician.
Conclusion of the European evaluation
The PRAC recommends the implementation of new measures for all European countries to avoid exposure during pregnancy to medicines containing topiramate.
Due to the risk of major congenital malformations, topiramate was already contraindicated for the prevention of migraine in pregnant women or in women of childbearing age not using a highly effective contraceptive method.
The PRAC now recommends that topiramate should not be used in epilepsy during pregnancy unless no other medicine is effective.
The PRAC also recommends additional risk reduction measures, notably through the provision of a patient card, in order to avoid exposure during pregnancy and to inform any young girl or woman of childbearing age. children of the risks associated with taking topiramate during pregnancy as well as the need to avoid becoming pregnant during treatment with topiramate.
The marketing authorizations (AMM) for specialties containing topiramate will be updated to detail these new risks and the measures to be taken.
Health professionals will soon be informed by mail of these new measures.
1694445098
#News #Topiramate #Epitomax #generics #neurodevelopmental #disorders #implementation #measures #Europe #limit #pregnancy
