Use of topiramate in pregnancy and risk of oral clefts
Published Date:Jul 16 2012
Source:Am J Obstet Gynecol. 2012; 207(5):405.e1-405.e7.
Corporate Authors:National Birth Defects Prevention Study
Pubmed Central ID:PMC3484193
Funding:FOA DD09-001/DD/NCBDD CDC HHS/United States
PA 02081/PHS HHS/United States
PA 96043/PHS HHS/United States
R01 HD 046595/HD/NICHD NIH HHS/United States
R01 HD046595/HD/NICHD NIH HHS/United States
U50/CCU113247/PHS HHS/United States
To evaluate the association between monotherapy topiramate use in pregnancy and cleft lip with or without cleft palate (CL/P) in the offspring.
Data from the Slone Epidemiology Center Birth Defects Study (BDS) from 1997–2009 and the National Birth Defects Prevention Study (NBDPS) from 1997–2007 were analyzed. Conditional logistic regression was used to compare first-trimester use of topiramate monotherapy to no antiepileptic drug use during the periconceptional period between mothers of infants with CL/P and mothers of controls for each study separately, and in pooled data.
BDS contained 785 CL/P cases and 6,986 controls; NBDPS contained 2,283 CL/P cases and 8,494 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 BDS, 3.6 (0.7; 20.0) in NBDPS, and 5.4 (1.5; 20.1) in pooled data.
First-trimester use of topiramate may be associated with CL/P.
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