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Re-activateThe anti-seizure drug topiramate (Topamax and generic) might cause cleft lips and palates in children born to women who take the medication while pregnant, according to a new warning from the Food and Drug Administration. Topamax treats epileptic seizures and is also approved for migraine prevention. It's also prescribed off-label by some doctors to treat alcohol dependence, and, in some cases, as a weight-loss aid.
The drug will now be labeled as as a Class D drug, meaning there's evidence of fetal risk in humans, according to the FDA. If you're a woman with epilepsy of childbearing age, talk with your doctor about other alternatives before agreeing to take the medication. It is important that women avoid seizures during pregnancy, so in certain situations the potential benefit of the drug may outweigh the risks.
Oral clefts occur when parts of the lip or palate do not fuse together completely early in the first trimester, at a time when many women may not yet know they are pregnant. The cleft can range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, leading to problems with eating, talking, and ear infections.—Maggie Shader
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