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Anticonvulsant Topamax May Cause Birth Defects

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As anticonvulsant drugs like Ortho-McNeil Pharmaceuticals’ Topamax become more and more popular in the United States, drug regulators are warning consumers that these medications may be linked to major birth defects when taken during pregnancy. Topamax was approved by the FDA in 1996 as a treatment for epilepsy, and was additionally approved in 2004 to prevent migraine headaches. The active ingredient in Topamax is topiramate, and the drug functions by interfering with the firing of certain impulses in the brain that cause seizures. Unfortunately, with the release of new Topamax birth defect information, the anticonvulsant may no longer be considered a safe treatment in pregnancy.

Topamax and Migraine Headaches

Migraine headaches can cause debilitating pain and are more common among women of childbearing age than any other population. Unfortunately, because nearly half of all pregnancies in the U.S. are unplanned, all women of childbearing age taking Topamax may be at risk of causing serious harm to their unborn child before they are even aware they are pregnant. In light of this birth defect information, the FDA issued a safety announcement last year recommending that physicians consider alternative treatments for women of childbearing age, especially for conditions not typically associated with permanent injury or death.

Topamax’s Pregnancy Category Elevated

Because of the risk of birth defects associated with Topamax, the FDA safety notice also elevated the pregnancy category of Topamax from C to D, which is the second highest category available in classifying the pregnancy risks of medications. The agency warned patients and healthcare providers about the release of new data suggesting an increased risk of birth defects like cleft lip and cleft palate among children born to women who receive Topamax treatment in pregnancy. Despite these serious birth defects, Topamax remains a popular anticonvulsant, with 32.3 million prescriptions dispensed between January 2007 and December 2010.


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