Use of topiramate in pregnancy and risk of oral clefts

Details

• Alternative Title:
  Am J Obstet Gynecol
• Personal Author:
  Margulis, Andrea V ; Mitchell, Allen A ; Gilboa, Suzanne M ; Werler, Martha M ; Mittleman, Murray A ; Glynn, Robert J ; Hernandez-Diaz, Sonia
• Corporate Authors:
  National Birth Defects Prevention Study
• 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.
  
  
• Subjects:
  Adult Anticonvulsants Case-Control Studies Cleft Lip Cleft Palate Congenital Abnormalities Epilepsy Female Fructose Humans Incidence Pregnancy Pregnancy Trimester, First Prenatal Exposure Delayed Effects Prevalence Topiramate

  More +
• Source:
  Am J Obstet Gynecol. 2012; 207(5):405.e1-405.e7
• Pubmed ID:
  22917484
• Pubmed Central ID:
  PMC3484193
• Document Type:
  Text
• Funding:
  FOA DD09-001/DD/NCBDD CDC HHS/United States ; P30 ES000002/ES/NIEHS NIH HHS/United States ; R01 HD046595/HD/NICHD NIH HHS/United States ; PA 02081/PHS HHS/United States ; PA 96043/PHS HHS/United States ; R01 HD 046595/HD/NICHD NIH HHS/United States ; U50/CCU113247/PHS HHS/United States
• Genre:
  Journal Article
• Volume:
  207
• Issue:
  5
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha-512:f3ffa9cc3c8b109fa6c9650e93ebab32b77a9fe676df5f7571698d9c967c88f68f0f38d4cd44409d847c4aa33a00e8a87d9d891e445236a2bf3870ce0f377523
• Download URL:
  https://stacks.cdc.gov/view/cdc/33457/cdc_33457_DS1.pdf
• File Type:
  [PDF - 51.66 KB ]