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Key Findings: Use of topiramate in pregnancy and risk of oral clefts

Patient and Doctor

The American Journal of Obstetrics and Gynecology has published a new study: “Use of topiramate in pregnancy and risk of oral clefts.” You can read the article’s abstract here. See below for a summary of the findings from this article.

Main Finding from this Study

Use of topiramate during the first trimester of pregnancy was associated with an increased risk of oral clefts (i.e., cleft lip with or without cleft palate) in the offspring.

About this Study

  • What is topiramate?
    Topiramate is a medication used to treat epilepsy. It is also considered for treatment of sleep and eating disorders, migraines, other psychiatric conditions, and weight loss. Topiramate is also a component of Qsymia, a medicine which was approved by the Food and Drug Administration (FDA) on 7/17/2012 for chronic weight management. For more information on this weight loss medicine, please see the FDA press release here.

    Topiramate is currently considered a Category D medication by the FDA. This means that potential risks of using the medicine during pregnancy have been recognized, but benefits of the medicine may warrant use despite the risks.

  • What were the study results?
    This study looked at the risk of oral clefts in infants whose mothers took topiramate during the first trimester of pregnancy. It used data from two large birth defects case-control studies (Slone Epidemiology Center Birth Defects Study and National Birth Defects Prevention Study). Both studies showed an increased risk of oral clefts in infants exposed to topiramate during the first trimester compared to infants not exposed to antiepileptic medicines.
  • What is currently known on this subject?
    Previous studies have shown a potential association between oral clefts and the use of topiramate during pregnancy. However, this association has been hard to evaluate because both the use of topiramate during pregnancy and the occurrence of oral clefts are rare.
  • What does this study add?
    This study supports previous findings showing an increased risk of oral clefts among infants exposed to topiramate. Assuming this study is correct, this means that for any pregnancy exposed to topiramate, the risk of oral clefts in the offspring would be increased 5-fold. However, because oral clefts are a rare occurrence, it is important to keep the absolute risks in mind. Approximately 1 in 1,000 infants is born with cleft lip with or without cleft palate in the US each year1, and for any topiramate-exposed pregnancy, the risk would increase to approximately 5 in 1,000 infants.

Please Remember

When making treatment decisions just before or during pregnancy, it is important that women and their doctors weigh the benefits of medications, such as topiramate, along with their potential risks for birth defects.

Medication during pregnancy: CDC’s Activities

About 1 in every 33 babies is born with a birth defect.2 Birth defects are one of the leading causes of infant deaths, accounting for more than 20% of all infant deaths.3 CDC is committed to working with its partners and the public to build a comprehensive approach to understanding and communicating the risks of birth defects that potentially are associated with the use of medications during pregnancy.

  • Research: CDC funds a large study of birth defects called the National Birth Defects Prevention Study. This study is working to identify risk factors for birth defects and to answer questions about some medications taken during pregnancy.
  • Technical expertise: CDC works with staff from the U.S. Food and Drug Administration and other professionals to help conduct studies on the effects of medication use during pregnancy and ways to prevent harmful effects.

More Information

To learn more about medication use during pregnancy, please visit our medication and pregnancy website.

For more information about birth defects, please visit our website on birth defects.

  1. Parker SE, Mai CT, Canfield MA, et al. Updated National Birth Prevalence Estimates for Selected Birth Defects in the United States, 2004-2006. Birth Defects Res A Clin Mol Teratol. 2010;88(12):1008-16.
  2. Centers for Disease Control and Prevention. Update on Overall Prevalence of Major Birth Defects–Atlanta, Georgia, 1978-2005. MMWR Morb Mortal Wkly Rep. 2008;57(1):1-5.
  3. Heron MP, Hoyert DL, Murphy SL, Xu JQ, Kochanek KD, Tejada-Vera B. Deaths: Final data for 2006. National vital statistics reports; vol 57 no 14. Hyattsville, MD: National Center for Health Statistics. 2009.
Reference for Key Findings Feature

Margulis AV, Mitchell AA, Gilboa SM, et al. Use of topiramate in pregnancy and risk of oral clefts. Am J Obstet Gynecol. 2012 [epub ahead of print].

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