Topiramate is an anti-epileptic drug and is also recommended for the prevention of migraines in adults.

Action taken in Pakistan:

The case was discussed in the 4th meeting of the Pharmacovigilance Risk Assessment Expert Committee of DRAP, which decided to update the prescribing information of topiramate to include the risk of fetal neurodevelopmental disorders and a warning for women of childbearing age. Moreover, it should not be used prophylactically for migraine in pregnant and childbearing-age women.

Background

Medsafe New Zealand announced in April 2023 that topiramate has been updated to include the risk of neurodevelopmental disorders and birth abnormalities in expecting mothers. Neurodevelopmental disorders were observed during an observational study of five Nordic (Denmark, Finland, Iceland, Norway, and Sweden) pregnancy registries. In June 2023, the TGA Australia also announced that the topiramate was updated to include the risk of fetal neurodevelopmental disorders, an updated warning for women of childbearing age, and a contradiction for pregnant women. The European Medicine Agency began a review of the data in July 2023, and the study concluded that using topiramate during pregnancy increases the risk of autism spectrum disorders, intellectual disability, and child neurodevelopmental disorders. As a result, the Pharmacovigilance Risk Assessment Committee restricted the use of topiramate in September 2023. Currently, topiramate must not be used to prevent migraines or to manage body weight during pregnancy.

Guidelines for health care professionals:

DRAP advised health care professionals to use topiramate in order to treat epilepsy during pregnancy if the potential benefit outweighs the potential risk. Prophylactic use of topiramate to prevent migraines is contraindicated in pregnant women.