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Topamax to Get New Classification Based on Birth Defect Risk

On March 4, 2011, the FDA announced that the anti-epilepsy drug topiramate would be switched pregnancy category C to pregnancy catergory D. The FDA classifies drugs through an alphabetical category scale for use in pregnant women. Category D means there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

The new classification for topiramate, sold under the brand name Topamax, is based on results from studies showing a tripling of the risk of cleft palate and other birth defects of the oral cavity when taken during the first trimester of pregnancy compared with other anti-epilepsy drugs. Topamax is also FDA-approved for preventing migraine headaches.

According to the FDA, the benefits and risks of Topamax should be carefully considered when prescribing the drug to women of childbearing age. Using Topamax to treat epilepsy in pregnant women may be appropriate given the non-life-threatening nature of the birth defect. However, use for other indications such as migraine headache may not be worth the significantly increased risk of cleft palate in babies born to mothers taking Topamax.

Contact an experienced dangerous drug lawyer today for a free consultation.

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