Topamax
Topamax, which is also available as generic topiramate, is an anticonvulsant medication approved to treat patients with epilepsy who have certain types of seizures. Topiramate is also approved for use to prevent migraine headaches. Topamax has been associated with an increased risk of major birth defects. Research has found higher than expected rates of babies born with cleft lips, cleft palates, genital defects and other birth malformations when the drug is used during pregnancy.
Federal regulators have asked Vivus, Inc. to review potential reports of oral clefts, which may include a cleft lip or cleft palate, among children born to women who took Topamax during pregnancy after several published reports involving the birth defects.
In 2008, a study published in the medical journal Neurology found that a higher-than-expected number of pregnant women treated with Topamax gave birth to babies with cleft lips, cleft palates, genital defects or other birth malformations. Although the Topamax birth defect study was small, only involving 178 babies, the rate of birth defects was 11 times higher than would be expected in the general population.
