A headache medication for migraines increases the risk for birth defects in babies born to pregnant mothers taking the medication, U.S. health officials said on Friday.
The Food and Drug Administration said new data shows the drug, sold generically and as Johnson & Johnson's Topamax, can cause cleft lips or cleft palate deformities.
Officials called on doctors to warn their female patients of childbearing age who are taking the medicine about its risks.
FDA's Russell Katz, who heads the agency's Division of Neurology Products, said doctors should think carefully before prescribing the drug to women and "alternative medications that have a lower risk of birth defects should be considered."
Cleft lips and cleft palates occur when the mouth does not fully form, causing a "split lip" or a hole in the roof of the mouth.
They can lead to multiple development issues because they can make it nearly impossible for babies to get adequate nutrition. They can be corrected with surgery, although sometimes several operations are needed.
Teva Pharmaceutical Industries Ltd, Watson Pharmaceuticals Inc, Mylan Inc and other generic drug makers also sell the drug under its chemical name topiramate.
FDA issued the warning based on data collected from the North American Antiepileptic Drug Pregnancy Registry, it said.