PRAC Recommends New Measures to Avoid Topiramate Exposure in Pregnancy

In a European Medicines Agency (EMA) press release on September 9, 2023, the agency’s Pharmacovigilance Risk Assessment Committee (PRAC) outlined new measures to avoid fetus exposure to topiramate-containing medicines. Topiramate is known to cause serious birth defects if used during pregnancy, and medicines containing it may increase the risk of neurodevelopmental problems in children. In the European Union, topiramate-containing medicines are used to treat epilepsy and prevent migraines; in some EU countries they are also used with phentermine for weight loss.

As of the publication of this article, PRAC recommends that unless there is no other treatment available, patients using topiramate to treat epilepsy should not use the medication while pregnant. Topiramate must not be used to prevent migraines or manage body weight while pregnant, and patients who are able to become pregnant must use birth control while taking topiramate. PRAC also recommends a pregnancy prevention program to inform those able to become pregnant of the risks associated with topiramate exposure in the womb.

Regardless of indication, topiramate should only be used by patients who can become pregnant when the following conditions are met:

• the patient must take a pregnancy test before starting treatment

• they must receive counseling on the risks of topiramate treatment during pregnancy
• they must complete an annual risk awareness form during treatment.

These recommendations follow PRAC’s review of three recent observational studies, two of which suggest that children exposed to topiramate in the womb have a two- to three-fold higher risk of neurodevelopmental disorders. PRAC consulted with a group of experts, patient representatives, and specialists during the review. Companies marketing topiramate must conduct a drug utilization study, as well as surveys of healthcare professionals and patients, to evaluate the success of the new measures.

The product information for topiramate-containing medicines will be updated, and a visible warning will be added to the packaging of the medicine. Patients and healthcare professionals will also be provided with information on the risks of using the medication during pregnancy, and patients will be given a patient card with each package of the medicine.

A direct healthcare professional communication will be sent to healthcare professionals prescribing, dispensing, or administering the medicine. It will also be published on EMA’s website.

Source: EMA