Consumer Alert: FDA Warns Prescription Drug TOPAMAX® Causes Birth Defects

On March 4, 2011, the U.S. Food and Drug Administration ("FDA") issued a Press Release regarding the prescription drug TOPAMAX®.[1] According to the FDA, data from the North American Antiepileptic Drug Pregnancy Registry revealed an increased risk of certain birth defects, including cleft lip and/or cleft palate, in infants exposed to TOPAMAX® during the first trimester of pregnancy.[2] The relative risk of oral clefts in topiramate-exposed pregnancies in the NAAED Pregnancy Registry was 21.3 as compared to the risk in a background population of untreated women.[3] A similar registry in the United Kingdom also reported an increased risk of oral clefts in infants exposed to TOPAMAX®.[4]

TOPAMAX® is manufactured by Ortho-McNeil Janssen[5], and was originally approved on December 24, 1996 for the treatment of primary generalized tonic-clonic seizures.[6] On August 10, 2004, the FDA approved TOPAMAX® use for prevention of migraine headaches.[7] TOPAMAX® has also been prescribed for "off-label" (not approved by the FDA) for conditions not considered serious.[8] TOPAMAX® was originally classified as a "Category C" medication for purposes of evaluating use in pregnant patients. As of March 4, 2011, the FDA recategorized TOPAMAX® from a pregnancy warning changed from Category C to Category D. Between January 2007 and December 2010, the FDA approximates 32.3 million prescriptions were dispensed to 4.3 million patients in the United States.[9]

The FDA recommends that women of childbearing age be informed of the increased risk for birth defects when TOPAMAX® is used in the first trimester of pregnancy.[10] Given this increased risk, the FDA directs healthcare professionals treating any women of childbearing age to consider alternative mediations that have a lower risk of birth defects and other adverse birth outcomes, "particularly when treating a condition not usually associated with permanent injury or death".[11] TOPAMAX® is known to decrease the efficacy of certain oral contraceptives.[12]

Robins, Kaplan, Miller & Ciresi L.L.P. is investigating potential claims on behalf of parents and children born to mothers taking TOPAMAX®. If you wish to speak with us about a potential claim of an injury caused by TOPAMAX®, please call Kathy Neuman, R.N., B.S.N., at 1.800.553.9910, or contact us here.

[1] U.S. Food and Drug Administration, FDA: Risk of Oral Birth Defects in Children Born to Mothers Taking Topiramate (March 4, 2011)
[2] Id.
[3] Id.
[4] Id.
[5] See http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails
[6] See http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist
[7] See http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20505s022,025,20844s019,021ltr.pdf
[8] Supra, note 1.
[9] Id. (citing SDI, Vector One: National (VONA) and Total Patient Tracker (TPT). January 2007 - December 2010. Data extracted 2/9/11).
[10] U.S. Food and Drug Administration, FDA Drug Safety Communication: Risk of Oral Clefts in Children Born to Mothers Taking Topamax (topiramate), March 4, 2011)
[11] Id.
[12] Id.