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

Apr 8, 2011

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.

© Copyright 2011.  All rights reserved.

[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
[6] See
[7] See,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.


The articles on our website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice. The views and opinions expressed in this article are those of the author(s) and do not necessarily reflect the views or official position of Robins Kaplan LLP.


Tara D. Sutton


Chair, National Mass Tort Group

Kathryn Neuman, RN

Legal Nurse Consultant


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