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Use of topiramate in pregnancy and risk of oral clefts

Andrea V Margulis1, Allen A Mitchell, Suzanne M Gilboa

  • 1Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, USA. andreamargulis@post.harvard.edu

American Journal of Obstetrics and Gynecology
|August 25, 2012
PubMed

Insights

First-trimester use of topiramate, an antiepileptic drug, may increase the risk of cleft lip with or without cleft palate (CL/P) in newborns. This finding suggests caution when prescribing topiramate during early pregnancy.

Area of Science:

  • Obstetrics and Gynecology
  • Pediatric Neurology
  • Teratology

Background:

  • Topiramate is an antiepileptic drug with a known risk profile.
  • Understanding drug safety during pregnancy is crucial for maternal and infant health.

Purpose of the Study:

  • To investigate the association between monotherapy topiramate use during pregnancy and the occurrence of cleft lip with or without cleft palate (CL/P) in offspring.

Main Methods:

  • Analysis of data from the Slone Epidemiology Center Birth Defects Study (BDS) and the National Birth Defects Prevention Study (NBDPS).
  • Conditional logistic regression was employed to compare first-trimester topiramate monotherapy exposure versus no antiepileptic drug use.
  • Data were analyzed separately for each study and in pooled analyses.

Main Results:

  • The study included a significant number of cases and controls across both BDS and NBDPS datasets.
  • An increased odds ratio for CL/P was observed with topiramate use: 10.1 in BDS, 3.6 in NBDPS, and 5.4 in pooled data.
  • The pooled analysis indicated a statistically significant association between first-trimester topiramate exposure and CL/P.

Conclusions:

  • First-trimester exposure to topiramate monotherapy during pregnancy is potentially associated with an increased risk of CL/P in infants.
  • These findings highlight the importance of careful consideration of antiepileptic drug use during early pregnancy.
Abstract

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