FDA To Up Topamax Warning Over Birth Defect Data

Law360, New York (March 4, 2011, 1:38 PM EST) -- The U.S. Food and Drug Administration announced Friday that it would amp up the warning label for Ortho-McNeil-Janssen Pharmaceuticals Inc. epilepsy and migraine drug Topamax after new data suggested that using the drug during pregnancy can lead to birth defects.

Data from the North American Antiepileptic Drug Pregnancy Registry linked an increased risk of cleft lips and cleft palates to infants who are exposed to Topamax and its generic versions during the first trimester of pregnancy, the FDA said.

Similar data from the U.K. Epilepsy and...
To view the full article, register now.