Birth Defect Data – North American Antiepileptic Drug Pregnancy Registry Collecting Data on Topamax

For women who have been prescribed an antiepileptic drug for any reason, planning for and experiencing a pregnancy can be the source of significant concern. The links between anticonvulsant medications and serious birth defects has been well-documented in medical research and keeping both mother and child healthy throughout a pregnancy can be a complicated matter. In fact, just this last week, the FDA issued a news release that data indicates yet another anti-seizure drug—Topamax (topiramate)—increases the risk for serious birth defects if taken during pregnancy. Topamax and its generic versions are used to treat epileptic patients and both have also been prescribed to prevent migraine headaches.

The data which led the FDA to issue its news release emerged from the North American Antiepileptic Drug Pregnancy Registry, which is an information-gathering effort dedicated to determine the safety for women during pregnancy of anticonvulsant medications used to treat disorders such as epilepsy, mood disorder, and chronic pain. Specifically, by gathering information, the registry is seeking to determine the frequency of major malformations such as heart defects, spina bifida, and cleft lip. In the case of Topamax, data from the Registry indicated that infants had an increased risk of oral clefts. This information will result in new warning information being required on Topamax that will indicate that there is evidence of human fetal risk.

The recent information release related to Topamax underscores the importance of medical data-collecting efforts such as the Antiepileptic Drug Pregnancy Registry. The Registry, which has been gathering data in the United States and Canada since 1997, provides medical researchers, physicians and patients with important health care information. Ultimately, the goal is to help identify, through independent research and data gathering, the safest anticonvulsant drugs for women.

Any woman who is currently pregnant and taking antiepileptic drugs for any reason can call toll-free at 1-888-233-2334 to enroll in the registry; participation involves three brief telephone interviews.