Topamax Birth Defects: Cleft Palate, Cleft Lip, Genital Defects

Austin Kirk

By Austin Kirk
Posted July 23, 2008


UPDATE 3/7/2011: The FDA has changed Topamax’s classification from a Pregnancy Category C drug to a Category D drug, warning about the risk of Topamax birth defects, such as cleft palate and cleft lip.

The use of Topamax during pregnancy has been linked to an increased risk of birth defects, such as cleft palates, cleft lips, genital defects. Topamax lawsuits are being reviewed by the lawyers at Saiontz & Kirk, P.A. for babies born with a malformation or defect after the drug was taken during pregnancy.

Topamax, which is also available as generic topiramate, is approved for treatment of epilepsy and migraines. It is manufactured and sold by Ortho-Mcneil Neurologics as well as several generic drug makers.

A new study published in the current issue of the medical journal Neurology indicates that women who received the drug to prevent seizures associated with epilepsy, either alone or in combination with other epilepsy medications, had a much higher incidence of delivering babies with birth defects. Topamax use during pregnancy resulted in babies born with cleft lips or palates at a rate 11 times higher than would be expected in the general population and babies born with genital defects at a rate 14 times higher than would be expected.

The study only involved 178 babies born to women who took Topamax or generic topiramate during pregnancy, but 16 of the babies had major birth defects. Researchers indicated that these findings may be a signal of real concern for doctors and patients prescribed Topamax to treat migraines, since it is a condition that frequently develops among women of childbearing age. Since the drug was approved for treatment of migraines in 2006, Topamax has become one of the most widely prescribed migraine drugs in the United States.


Researchers indicate that further studies are necessary to confirm these results since the study was small, and this is the first human study which found an increased risk of birth defects associated with Topamax side effects. The product liability lawyers at Saiontz & Kirk, P.A. are closely following the research and reviewing potential Topamax lawsuits on behalf of babies born with a cleft palate, cleft lip, genital malformations or other birth defects after the mother used the medication during pregnancy.

To review a potential case and evaluate what legal rights may be available, request a free consultation.

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