Use of topiramate in pregnancy and risk of oral clefts

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

doi:10.1016/j.ajog.2012.07.008

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Use of topiramate in pregnancy and risk of oral clefts

Published Date:

Jul 16 2012

Publisher's site:

http://dx.doi.org/10.1016/j.ajog.2012.07.008 New Site Icon

Source:

Am J Obstet Gynecol. 2012; 207(5):405.e1-405.e7.

[PDF - 51.66 KB]

Details:

Personal Authors:

Margulis, Andrea V ; Mitchell, Allen A ; Gilboa, Suzanne M ; Werler, Martha M ; Mittleman, Murray A ; ... More ▼

Corporate Authors:

National Birth Defects Prevention Study

Keywords:

[+]

Pubmed ID:

22917484

Pubmed Central ID:

PMC3484193

Description:

Objective

To evaluate the association between monotherapy topiramate use 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 1997–2009 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.

Results

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.

Conclusions

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

Document Type:

Journal Article

Collection(s):

CDC Public Access

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

Supporting Files:

nihms394637.nxml

application/octet-stream

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