Literature DB >> 22917484

Use of topiramate in pregnancy and risk of oral clefts.

Andrea V Margulis1, Allen A Mitchell, Suzanne M Gilboa, Martha M Werler, Murray A Mittleman, Robert J Glynn, Sonia Hernandez-Diaz.   

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.
Copyright © 2012 Mosby, Inc. All rights reserved.

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Year:  2012        PMID: 22917484      PMCID: PMC3484193          DOI: 10.1016/j.ajog.2012.07.008

Source DB:  PubMed          Journal:  Am J Obstet Gynecol        ISSN: 0002-9378            Impact factor:   8.661


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