Document Detail

Use of topiramate in pregnancy and risk of oral clefts.
MedLine Citation:
PMID:  22917484     Owner:  NLM     Status:  MEDLINE    
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.
Andrea V Margulis; Allen A Mitchell; Suzanne M Gilboa; Martha M Werler; Murray A Mittleman; Robert J Glynn; Sonia Hernandez-Diaz;
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, P.H.S.     Date:  2012-07-16
Journal Detail:
Title:  American journal of obstetrics and gynecology     Volume:  207     ISSN:  1097-6868     ISO Abbreviation:  Am. J. Obstet. Gynecol.     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-10-30     Completed Date:  2013-01-22     Revised Date:  2013-11-06    
Medline Journal Info:
Nlm Unique ID:  0370476     Medline TA:  Am J Obstet Gynecol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  405.e1-7     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2012 Mosby, Inc. All rights reserved.
Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, USA.
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MeSH Terms
Anticonvulsants / administration & dosage,  adverse effects*
Case-Control Studies
Cleft Lip / chemically induced*,  epidemiology
Cleft Palate / chemically induced*,  epidemiology
Epilepsy / drug therapy,  epidemiology
Fructose / administration & dosage,  adverse effects,  analogs & derivatives*
Pregnancy Trimester, First / drug effects
Prenatal Exposure Delayed Effects / epidemiology*
Young Adult
Grant Support
FOA DD09-001/DD/NCBDD CDC HHS; PA 02081//PHS HHS; PA 96043//PHS HHS; R01 HD 046595/HD/NICHD NIH HHS; R01 HD046595/HD/NICHD NIH HHS; U50/CCU113247//PHS HHS
Reg. No./Substance:
0/Anticonvulsants; 0H73WJJ391/topiramate; 30237-26-4/Fructose
Comment In:
Am J Obstet Gynecol. 2012 Nov;207(5):e1-2   [PMID:  23107084 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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