Topamax Birth Defect Information

Topamax is an epilepsy and migraine drug manufactured by Ortho McNeil (a division of Johnson & Johnson), which is also used off-label to treat psychiatric disorders. It was approved by the Food and Drug Administration (FDA) for epilepsy and seizure treatment in 1979 and for migraine treatment in 2004.  In March, 2011, the FDA issued a warning that Topamax may increase the risk of oral cleft birth defects (cleft lip and cleft palate) among babies whose mothers use the drug during the first trimester of pregnancy.

The FDA also changed the Topamax label classification to Pregnancy Category D drug, which means that there is scientific evidence that the drug causes birth defects in humans. Pregnancy Category D drugs should be used during pregnancy only if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective. Prior to March, 2011, Topamax was classified as a  Pregnancy Category C drug, meaning there was evidence of birth defects in animals but not humans, and that it could be used with caution during pregnancy. There are alternative epilepsy and migraine drugs that may not carry the same risks as Topamax.

The FDA’s new warnings came after data from the North American Antiepileptic Drug Pregnancy Registry found that children born to mothers who took Topamax during the first trimester of pregnancy experienced oral cleft defects at a rate of 2.55 to 4.24 times more often than those whose mothers used other epilepsy drugs. Also, in 2008, another study found that children born to mothers who used Topamax during pregnancy had an oral cleft defect rate 11 times higher than would be expected in the normal population, and genital defects at a 14 times higher rate than the general population.

If you or someone you love has been injured by the use of Topamax, call the experienced pharmaceutical attorneys at Schlichter, Bogard & Denton for a free consultation.