Topamax Cleft Palate and Lip Side Effects: Warnings Should Have Been Provided Earlier

Austin Kirk

By Austin Kirk
Posted March 15, 2011


Earlier this month the FDA required the makers of Topamax and generic topiramate to update their warning label about the risks associated with use of the epilepsy drug during pregnancy, which could cause children to be born with a cleft lip or cleft palate from Topamax. However, it appears that information has been available for years that Topamax side effects may cause birth defects and malformations, yet the manufacturers failed to adequately research their medication or warn consumers and doctors.

>>INFORMATION: Topamax Cleft Lip and Cleft Palate Side Effects

The Topamax lawyers at Saiontz & Kirk, P.A. first began evaluating potential lawsuits for children diagnosed with a cleft palate, cleft lip or genital defects from Topamax after a study was released in July 2008.

That study, which was published in the medical journal Neurology, indicated that pregnant women who received Topamax to prevent seizures associated with epilepsy, faced a much higher incidence of delivering babies with birth defects or malformations. Topamax use during pregnancy was linked to the delivery of babies with cleft lip or cleft palate at a rate 11 times higher than would be expected in the general population and babies born with genital defects from Topamax at a rate 14 times higher than would be expected.

Although this research and other post-marketing data were available to the manufacturers, they failed to warn women of childbearing potential about the risks of pregnancy and Topamax. If proper warnings had been provided, women could have elected to take a different drug or taken steps to ensure they did not become pregnant on Topamax.

Rather than investigating the Topamax cleft palate side effects, the drug maker chose to turn a blind eye and withhold critical information from consumers and the medical community. Until the FDA mandated warning label changes last month, the prior information provided by the manufacturer was vague and confusing, indicating that that they had conducted no studies on use of Topamax by pregnant women.

New data provided by the FDA earlier this week seems to confirm the risk of cleft lip and cleft palate from Topamax side effects. According to reports made to the North American Antiepileptic Drug Pregnancy Registry, the prevalence of oral clefts in children born to mothers who used Topamax while pregnant was 20 times higher than among women who did not take any antiepiletic drug. When compared to other epilepsy drugs, the prevalence of birth defects was still 2-3 times greater with Topamax pregnancy use.

According to the FDA, data from the United Kingdom Epilepsy and Pregnancy Register also supported the Topamax cleft lip and palate risk. Similar information was certainly known or knowable by the drug makers, but they chose to ignore the risk and prevented women from making an informed decision before using Topamax for migraines or seizures during pregnancy.


As a result of the drug makers’ decision to place profits before safety, there are many children who have experienced problems that did not need to occur. Compensation may be available through a Topamax cleft palate or lip lawsuit for children who were exposed to the drug before they were born.

To review a potential claim for a family member or loved one, request a free consultation and claim evaluation by our one of Topamax attorneys.

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