The U.S. Food and Drug Administration has revealed new data that suggests the drug Topamax (topiramate) and its generic versions can increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy.
Topamax, marketed by Johnson & Johnson, is approved to treat certain types of seizures in people who have epilepsy. However, the FDA states patients should be warned about the potential hazard to the fetus if a woman becomes pregnant while using the drug.
The FDA raised the drug's pregnancy category to D, which means there is evidence the drug can harm a human fetus, but there are situations where the drug's benefits to the mother could outweigh its risks. They did not place the drug in category X, which means the drug should never be used by women who are or may become pregnant.
Data collected from a registry of pregnant women showed a higher rate of cleft lip and cleft palate in babies whose mothers were taking the drug during their first trimester of pregnancy. Infants exposed to the drug had a 1.4 percent rate of mouth defects, more than three times greater than the rate seen with other seizure medications. Mothers not taking any epilepsy medication delivered babies with mouth defects at a rate of .07 percent.
Dr. Russell Katz, M.D., director of the FDA's division of neurology products, cautions health care professionals to carefully consider the benefits and risks of topiramate when prescribing it to women of child-bearing age, according to a news release issued by the organization. He added that alternative medications with a lower risk of birth defects should be considered.
Roughly 4.3 million patients filled prescriptions for the drug between 2007 and 2010. The drug is also used to prevent migraine headaches.
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