PRAC recommends new measures to avoid topiramate exposure in pregnancy

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommends new measures to avoid exposure of children to topiramate-containing medicines in the womb, because the medicine may increase the risk of neurodevelopmental problems after exposure during pregnancy.

Topiramate, which is has been off-patent for a number of years, is already known to cause serious birth defects when used during pregnancy. It was originally sold by the USA’s Johnson & Johnson (NYSE: JNJ) under the trade name Topamax, as an add-on therapy for partial onset seizures in adults.

Topiramate‑containing medicines are used in the European Union for the treatment of epilepsy and prevention of migraine. In some EU countries, the medicine is also used in combination with phentermine for weight reduction. At present, topiramate must not be used to prevent migraine or manage body weight during pregnancy and patients who can become pregnant must use effective birth control when using topiramate.