WASHINGTON (AP) -- The Food and Drug Administration is warning women of child-bearing age that the epilepsy drug Topamax can increase the risk of birth defects around the mouth.
Data collected from a registry of pregnant women showed a higher rate of cleft lip and cleft palate in babies whose mothers were taking the drug during the first trimester.
Topamax is marketed by Johnson & Johnson to control seizures caused by epilepsy, a neurological disorder that causes excessive signals in the brain. The drug is also used to relieve migraine headaches.
J&J and generic drugmakers who market the drug, known as topiramate, will add a stronger warning label about the drug's effect on pregnancies.
Women taking topiramate should talk to their doctor immediately if they are planning to or become pregnant.