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Home / Uncategorized / Topamax® and Cleft Palate

Topamax® and Cleft Palate

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The U.S. Food and Drug Administration (FDA) has informed the public that there is new data that suggest that there is an increased risk for the development of cleft lip and/or cleft palate in infants born to women treated with topiramate (Topamax® and generic products) during pregnancy.

The announcement stated that topiramate (Topamax®) is being placed as a Pregnancy Category D drug. This means there is positive evidence of human fetal risk based on human data. There is not an absolute requirement that pregnant women not take the drug, but the potential benefits must be weighed against the risks.

The communication explained “The benefits and the risks of topiramate should be carefully weighed when prescribing this drug to women of childbearing age, particularly for conditions not usually associated with permanent injury or death”. If the decision is made to use topiramate in women of childbearing age, effective birth control should be used. Oral clefts occur in the first trimester of pregnancy before many women know they are pregnant.

Other drugs taken during pregnancy may also cause oral clefts including Paxil®, Depakote®, Dilantin®, Zoloft® and Sertraline®.

Source: FDA Drug Safety Communication: Risk of oral clefts in children born to mothers taking Topamax (topiramate), 03-04-2011.

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