Topamax Increases Risk for Cleft Lip, Cleft Palate When Used During Pregnancy

<"">Topamax (topiramate) has been associated with the development of oral clefts – cleft lip and/or cleft palate – in babies born to women who took the drug during early pregnancy. Today, the U.S. Food & Drug Administration (FDA) said that Topamax, previously classified as a Pregnancy Category C drug, will now be placed in Pregnancy Category D.

According to the FDA, the Pregnancy Category D designation means that there is positive evidence of human fetal risk based on human data, but the potential benefits of Topamax in pregnant women may outweigh the risks in certain situations. The new classification also applies to generic forms of Topamax.

Topamax is an anticonvulsant medication approved for use alone or with other medications to treat patients with epilepsy who have certain types of seizures. Topamax is also approved for use to prevent migraine headaches.

The FDA decided to move Topamax to Pregnancy Category D after Data from the North American Antiepileptic Drug (AED) Pregnancy Registry indicated that infants exposed to Topamax as a single therapy during the first trimester of pregnancy experienced a 1.4 percent prevalence of oral clefts, compared with a prevalence of 0.38 percent – 0.55 percent in infants exposed to other antiepileptic drugs. Infants of mothers who did not have epilepsy and were not being treated with other antiepileptic drugs had a prevalence of 0.07 percent.

According to the FDA, data from the United Kingdom Epilepsy and Pregnancy Register supported the North American AED Pregnancy Registry data.

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 do not know they are 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.

Healthcare providers have been advised by the FDA to inform women of childbearing age of the increased risk for oral clefts when Topamax is used in the first trimester of pregnancy, and to weigh the benefits and risks of Topamax when prescribing this drug to women of childbearing age, particularly when treating a condition not usually associated with permanent injury or death. If they decide to prescribe Topamax to women of childbearing age, doctors should recommend use of effective contraception.

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