Migraines, Pregnancy, and Topamax: New FDA Warning

Teri Robert @trobert Health Guide
  • The FDA has issued new warnings about Topamax (topiramate) a medication sometimes used for Migraine and headache prevention. New information from the North American Antiepileptic Drug (AED) Pregnancy Registry shows an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy. Oral clefts are cleft lip and cleft palate.

    Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, stated,

    "Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age. Alternative medications that have a lower risk of birth defects should be considered."3

    Cleft lip and cleft palate, collectively called oral clefts, are birth defects that occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women don't know they're pregnant. The defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking, and to ear infections. Surgery often is performed to close the lip and palate and most children do well after treatment.

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    For more information on this new FDA warning, see Pregnancy and Migraines: Topamax Warning, Cleft Defects.

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    Last updated March 6, 2011.

Published On: March 06, 2011