Use of topiramate in pregnancy and risk of oral clefts - 30/10/12
, Allen A. Mitchell, MD b, Suzanne M. Gilboa, PhD e, Martha M. Werler, ScD b, Murray A. Mittleman, MD, DrPH a, c, Robert J. Glynn, ScD d, Sonia Hernandez-Diaz, MD, DrPH aNational Birth Defects Prevention Study
Reprints: Andrea V. Margulis, MD, ScD, Harvard School of Public Health, Department of Epidemiology, 677 Huntington Ave., Kresge Building, Boston, MA 02115Résumé |
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.
Le texte complet de cet article est disponible en PDF.Key words : antiepileptic drugs, birth defects, cleft lip, oral clefts, topiramate
Plan
| This study was supported by cooperative agreement number U50/CCU113247 from the Centers for Disease Control and Prevention to the Slone Epidemiology Center through the Massachusetts Department of Public Health; cooperative agreements under PA 96043, PA 02081, and FOA DD09-001 from the Centers for Disease Control and Prevention to the Centers for Birth Defects Research and Prevention participating in the National Birth Defects Prevention Study; and grant R01 HD 046595 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. |
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| The pharmacoepidemiology program at Harvard School of Public Health, which granted a student stipend to A.V.M., received funds for training grants for students from Pfizer and Asisa. A.A.M. owns Johnson & Johnson stock currently valued at less than $20,000. The North American AED Pregnancy Registry, to which S.H.-D. devotes less than 5% of her time, received grants from multiple pharmaceutical companies. A.A.M., M.M.W., R.J.G., and S.H.-D. have consulted for or received grants from pharmaceutical companies whose medications are not the subject of this analysis. S.M.G. and M.A.M. report no potential conflict of interest. |
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| The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. |
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| Cite this article as: Margulis AV, Mitchell AA, Gilboa SM, et al. Use of topiramate in pregnancy and risk of oral clefts. Am J Obstet Gynecol 2012;207:292.405.e1-7. |
Vol 207 - N° 5
P. 405.e1-405.e7 - novembre 2012 Retour au numéro
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