FDA Warns of Birth Defects Linked to Epilepsy Medication


The epilepsy drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication while pregnant, the U.S. Food and Drug Administration said Friday. Before prescribing topiramate, which is approved to treat certain types of seizures in people who have epilepsy, health-care professionals should tell women of childbearing age about the potential risk, the agency said in a news release. Topiramate is also approved to prevent migraine headaches, but not to relieve migraine pain.

The Risks

"Health-care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age," said Dr. Russell Katz, director of the FDA's Division of Neurology Products. "Alternative medications that have a lower risk of birth defects should be considered."
Cleft lip and cleft palate are birth defects that occur when parts of the lip or palate don't completely fuse together early in the first trimester of pregnancy, a time when many women don't know they're pregnant. Surgery often is performed to close the lip and palate and most children do well after treatment, the FDA said.

New Data

Citing new data from the North American Antiepileptic Drug Pregnancy Registry, the FDA noted an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy. As a result, topiramate will have a stronger warning on its label, and the patient medication guide and prescribing information for Topamax and generic topiramate will be updated with the new information, the agency said.

Source: http://www.nj.com/newsflash/index.ssf/story/fda-warns-of-birth-defects-w...


Sponsored Links

Related Articles

  • article thumbnail
    Low Dose Oral Contraceptives
    Low dose oral contraceptives are just as effective as the “normal” dose oral contraceptives in preventing pregnancy. However the risk of heart attacks, blood clots, and st…
  • article thumbnail
    Oral Contraceptives and Breast Cancer
    Oral contraceptives and breast cancer have been a major concern for women for over fifty years. Scientists and researchers have been working diligently to provide answers abou…
  • article thumbnail
    Oral Sex and Cancer
    Researchers and scientists have recently linked a connection to oral sex and cancer. In this article, we are going to take a closer look at the types of cancer that have been …

Support Groups


For individuals, friends and families who are need to connect during life's challenging times. Share personal experiences, evaluate information and get support in a confidential, caring environment.



The information provided on Contracept.org is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her health professional. This information is solely for informational purposes and does not constitute the practice of medicine. We encourage all visitors to see a licensed physician or nutritionist if they have any concerns regarding health issues related to diet, personal image and any other topics discussed on this site. Neither the owners or employees of Contracept.org nor the author(s) of site content take responsibility for any possible consequences from any treatment, procedure, exercise, dietary modification, action or application of medication which results from reading this site. Always speak with your primary health care provider before engaging in any form of self treatment. Please see our Legal Statement for further information.

Sponsored Links

Login or Sign Up