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. 2012 Nov;207(5):405.e1-7.
doi: 10.1016/j.ajog.2012.07.008. Epub 2012 Jul 16.

Use of topiramate in pregnancy and risk of oral clefts

Andrea V Margulis  1 , Allen A Mitchell, Suzanne M Gilboa, Martha M Werler, Murray A Mittleman, Robert J Glynn, Sonia Hernandez-Diaz; National Birth Defects Prevention Study
Affiliations

Use of topiramate in pregnancy and risk of oral clefts

Andrea V Margulis et al. Am J Obstet Gynecol. 2012 Nov.

Abstract

Objective: The objective of this study was to evaluate the association between the use of monotherapy topiramate in pregnancy and cleft lip with or without cleft palate (CL/P) in the offspring.

Study design: Data from the Slone Epidemiology Center Birth Defects Study (BDS) from 1997 to 2009 and the National Birth Defects Prevention Study (NBDPS) from 1997 to 2007 were analyzed. Conditional logistic regression was used to compare the first-trimester use of topiramate monotherapy to no antiepileptic drug use during the periconceptional period between the mothers of infants with CL/P and the mothers of controls for each study separately and in pooled data.

Results: The BDS contained 785 CL/P cases and 6986 controls; the NBDPS contained 2283 CL/P cases and 8494 controls. The odds ratios (exact 95% confidence intervals) for the association between topiramate use and CL/P were 10.1 (1.1-129.2) in the BDS, 3.6 (0.7-20.0) in the NBDPS, and 5.4 (1.5-20.1) in the pooled data.

Conclusion: First-trimester use of topiramate may be associated with CL/P.

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Conflict of interest statement

Potential conflicts of interest

Dr. Margulis reported that the Pharmacoepidemiology program at Harvard School of Public Health, which granted her a student stipend, receives funds for training grants for students from Pfizer and Asisa. The North American AED Pregnancy Registry, to which Dr. Hernandez-Diaz devotes less than 5% of her time, received grants from multiple pharmaceutical companies. Dr. Mitchell reported having Johnson & Johnson stock currently valued at <$20,000. Drs. Mitchell, Werler, Glynn, and Hernandez-Diaz have consulted for or received grants from pharmaceutical companies whose medications are not the subject of this analysis.

Comment in

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