EU regulator recommends pregnant women not use epilepsy drug topiramate

[September 02, 2023]  (Reuters) -The European Medicines Agency's safety committee, on Friday, recommended pregnant women not use topiramate-containing medicines to prevent migraine or manage their body weight as their newborns could have a higher risk of neurodevelopmental disorders.

Topiramate‑containing medicines are currently used in the EU to treat epilepsy and prevent migraines, and in some EU countries, the medicine is also used in combination with phentermine to reduce weight.

The recommendations by the Pharmacovigilance Risk Assessment Committee (PRAC), including one that said women should avoid becoming pregnant while taking the drug, follow a review of three recent observational studies.

Two of those suggested that children born to women who took topiramate-containing medicines while pregnant may have a two- to three-fold higher risk of neurodevelopmental disorders than children born to women with epilepsy, but not taking antiepileptic medication.

The exterior of EMA, European Medicines Agency is seen in Amsterdam, Netherlands December 18, 2020. REUTERS/Piroschka van de Wouw/File Photo

These disorders include autism spectrum disorders, intellectual disability and attention deficit hyperactivity disorder (ADHD).

PRAC recommends that those using topiramate to treat epilepsy avoid doing so during pregnancy unless there is no other suitable treatment available.

(Reporting by Radhika Anilkumar and Yadarisa Shabong in Bengaluru; Editing by Savio D'Souza)

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