Topiramate carries risk of birth defect, says US FDA

New data suggest that the epilepsy drug US drug major Johnson & Johnson’s (NYSE: JNJ) Topamax (topiramate) and its generic versions (sold by the likes of Mylan, Teva and Watson) increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the US Food and Drug Administration warned on Friday.

Before prescribing topiramate, approved to treat certain types of seizures in people who have epilepsy, health care professionals should warn patients of childbearing age about the potential hazard to the fetus if a woman becomes pregnant while using the drug. Topiramate also is approved to prevent migraine headaches, but not to relieve the pain of migraines, the FDA stated.

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