Simmons Firm Investigates Birth Defects, Injuries Caused by Topamax

Simmons Browder Gianaris Angelides & Barnerd LLC is currently investigating a warning issued by the Food & Drug Administration that women who take Topamax, a drug used to treat epilepsy, during pregnancy increase the risk of their baby having an oral birth defect such as cleft lip and cleft palate.

Topamax (topiramate), sold by Johnson and Johnson, is used to treat epilepsy, migraines and pain. More than 32 million prescriptions for Topamax were issued between January 2007 and December 2010. It has also been the subject of previous lawsuits when its manufacturer marketed it for off-label uses such as obesity, bipolar disorder and alcoholism without FDA approval. 

New data from the North American Drug Pregnancy Registry has found that the risk of oral defects is 16 times higher among mothers who took Topamax or its generic versions during their first trimester compared to mothers who did not have epilepsy and were not being treated with other antiepileptic drugs, according to an FDA news release.

“Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, in the release. “Alternative medications that have a lower risk of birth defects should be considered.”

The FDA has required Johnson & Johnson, and the drug’s manufacturer Ortho MacNeil-Janssen Pharmaceuticals, Inc., to update Topamax’s label with stronger warnings. In addition, the agency has reclassified Topamax from Pregnancy Category C to Pregnancy Category D. This means evidence of a drug causing serious side effects during pregnancy exists, but the potential benefits of the drug in some cases may outweigh the benefits. 

Before starting treatment, FDA officials encourage pregnant women and women of childbearing age to discuss other treatment options with their doctor. Patients taking Topamax should not stop taking it unless they have consulted with their physician.

The dangerous drug attorneys at the Simmons Firm are experienced in addressing the legal concerns resulting for infant birth defects caused by Topamax, topiramate and its generic versions. To learn more about the firm’s on-going Topamax investigation, visit the firm’s web page at www.simmonspharmalaw.com