FDA Warns of Birth Defects Linked to Epilepsy Medication

The epilepsy drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication while pregnant, the U.S. Food and Drug Administration said Friday. Before prescribing topiramate, which is approved to treat certain types of seizures in people who have epilepsy, health-care professionals should tell women of childbearing age about the potential risk, the agency said in a news release. Topiramate is also approved to prevent migraine headaches, but not to relieve migraine pain.

The Risks

"Health-care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age," said Dr. Russell Katz, director of the FDA's Division of Neurology Products. "Alternative medications that have a lower risk of birth defects should be considered."
Cleft lip and cleft palate are birth defects that occur when parts of the lip or palate don't completely fuse together early in the first trimester of pregnancy, a time when many women don't know they're pregnant. Surgery often is performed to close the lip and palate and most children do well after treatment, the FDA said.

New Data

Citing new data from the North American Antiepileptic Drug Pregnancy Registry, the FDA noted an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy. As a result, topiramate will have a stronger warning on its label, and the patient medication guide and prescribing information for Topamax and generic topiramate will be updated with the new information, the agency said.

Source: http://www.nj.com/newsflash/index.ssf/story/fda-warns-of-birth-defects-w...