Topamax and pregnancy: A tricky mix

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Researchers have known for some time that a pregnant woman taking anti-convulsive medications faced a greater risk of bearing a child with a cleft palate. On Friday, the FDA went further, specifically warning women who are pregnant or who may become pregnant about Topamax (topiramate). Federal officials said that data from the North American Antiepileptic Drug Registry showed Topamax doubled or tripled the risk of cleft palate and cleft lip when taken during the first trimester compared with other anti-convulsives, and it boosted the risk of cleft palate disorder by 21-times when compared to pregnant women not taking any drugs.

This offers confirmation of research from the United Kingdom showing Topamax increased the likelihood of cleft-palate and cleft lip by 16-times when compared with not taking any drugs.

Between January 2007 and December 2010, Topamax was prescribed to 4.3 million patients in the U.S. through 32.3 million prescriptions. Granted those large numbers, ACSH's Dr. Gilbert Ross believes that “Doctors need to know about this, and they need to warn their female patients taking the drug who are in their fertile years about this possible risk factor.”

Still, government officials emphasized that having a cleft palate or a cleft lip is not life-threatening, and Dr. Ross points out that the absolute risk of cleft-palate disorder — 1.6 percent — is low even when taking Topamax. Further, he observes, “epilepsy is a very serious condition, one which may require treatment, even when a woman is expecting.”

“But,” he comments, “there are other anti-epileptic drugs like Dilantin which carry much lesser risks. And women who are taking Topamax off-label for appetite control or for migraines — and who are pregnant or who may become pregnant — should certainly be informed of the risk profile and of the alternatives.”