Quoted from http://www.reuters.com/article/2011/03/04/health-migraine-birthdefects-idUSN0417601520110304
Topamax, generics increase risk of cleft lip, palate
WASHINGTON, March 4 (Reuters) - An epilepsy drug also used to help prevent migraines can increase the risk for oral birth defects in babies born to women taking the medication, U.S. health officials said on Friday.
The Food and Drug Administration said new data shows expecting mothers taking the drug, sold generically and as Johnson & Johnson's (JNJ.N) Topamax, are about 20 times more likely to have their infants develop cleft lips or cleft palate deformities than those who are not treated.
Officials called on doctors to warn their female patients of childbearing age who are taking the medicine about its risks since the defects occur in the first three months of pregnancy, before women may know they are expecting.
FDA's Russell Katz, who heads the agency's Division of Neurology Products, said doctors should think carefully before prescribing the drug to women of childbearing age and "alternative medications that have a lower risk of birth defects should be considered."
Cleft lips and cleft palates are very rare in the United Stated but can occur when the mouth does not fully form, causing a "split lip" or a hole in the roof of the mouth.