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The Topamax and birth defects connection

Posted on April 14th, 2011 by Robert D. Rowland

We read every day about prescription drugs which harm people in ways they never imagined, with risks they would have never taken. As a parent, the only thing worse than taking a drug that harms you unexpectedly, is taking a drug which harms your child unexpectedly. Unfortunately, in March 2011, the U.S. Food and Drug Administration (FDA) issued a safety communication for patients and doctors warning of the risk of birth defects from the use of Topamax, a drug prescribed for treatment of epileptic seizures and chronic migraines.

Topamax (Topiramate) has been on the market since 1997. It was originally approved by the FDA for use to treat seizures. In November 2002, it was approved to treat migraines. Around the time of initial approval, literature began to surface suggesting an increased risk of giving birth to children with cleft lip and/or cleft palate to mothers who took Topamax during their first trimester of pregnancy. The tissue that becomes the lip forms as early as 5 to 6 weeks after conception, while the palate forms at 7 to 11 weeks after conception. The damage is done often before the mother even knows she is pregnant!

Despite the known birth defect risk, no warnings were provided to patients or doctors. According to the FDA news release dated March 4, 2011, data received from the North American Antiepileptic Drug Pregnancy Registry showed that the risk of cleft palates in infants exposed to Topiramate (Topamax) was over three times higher than the risk of cleft palates from other antiepileptic drugs. Only 0.07% of infants born to mothers who took no antiepileptic drug were born with cleft palates, while infants whose mothers took Topamax were 20 times more likely to have cleft palates.

Beyond the cleft palate and cleft lip injuries, additional birth defects have been linked to lesser degrees of use of Topamax in the first trimester. Topamax use has also been associated to limb malformation, heart defects, congenital defects, craniofacial defects, spina bifida and genital malformations.

Our firm is currently representing families who have been damaged by Topamax and would be happy to provide more information to concerned parents.

For more information on Topamax and birth defects, contact Robert D. Rowland.