title: Association between reported venlafaxine use in early pregnancy and birth defects, national birth defects prevention study, 1997-2007.
abstract: BACKGROUND
  Few epidemiologic studies have investigated the use of venlafaxine (Effexor XR capsules, Product Monograph, Wyeth, Montreal, Canada), an antidepressant used to treat major depression and anxiety disorders in adults, during pregnancy. Our objective was to determine whether use of venlafaxine during pregnancy is associated with specific birth defects.
  
  
  METHODS
  We used data from the National Birth Defects Prevention Study (NBDPS), a population-based, case-control study in the United States. Our analysis included mothers with pregnancies affected by one of 30 selected birth defects (cases) and babies without birth defects (controls) with estimated dates of delivery between 1997 and 2007. Exposure was any reported use of venlafaxine from 1 month preconception through the third month of pregnancy. We calculated adjusted odds ratios (aORs) and 95% Fisher Exact confidence intervals (CIs) for 24 birth defect groups for which at least 400 case mothers were interviewed. Our adjusted analyses controlled for maternal age and race/ethnicity.
  
  
  RESULTS
  Among the 27,045 NBDPS participants who met inclusion criteria, 0.17% (14/8002) of control mothers and 0.40% (77/19,043) of case mothers reported any use of venlafaxine from 1 month preconception through the third month of pregnancy. Statistically significant associations were found for anencephaly, atrial septal defect (ASD) secundum, or ASD not otherwise specified, coarctation of the aorta, cleft palate, and gastroschisis.
  
  
  CONCLUSIONS
  Our data suggest associations between periconceptional use of venlafaxine and some birth defects. However, sample sizes were small, CIs were wide, and additional studies are needed to confirm these results.
authors.affiliation: National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA. Kpolen@cdc.gov
authors.forename: Kara N D
authors.initials: KN
authors.lastname: Polen
authors.forename: Sonja A
authors.initials: SA
authors.lastname: Rasmussen
authors.forename: Tiffany
authors.initials: T
authors.lastname: Riehle-Colarusso
authors.forename: Jennita
authors.initials: J
authors.lastname: Reefhuis
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology / Q000209:etiology*; D000328:Adult; D000757:Anencephaly / Q000453:epidemiology / Q000209:etiology; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects*; D001017:Aortic Coarctation / Q000453:epidemiology / Q000209:etiology; D002972:Cleft Palate / Q000453:epidemiology / Q000209:etiology; D003511:Cyclohexanols / Q000009:adverse effects*; D005260:Female; D020139:Gastroschisis / Q000453:epidemiology / Q000209:etiology; D006344:Heart Septal Defects, Atrial / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D018811:Maternal Exposure / Q000009:adverse effects*; D016017:Odds Ratio; D011247:Pregnancy; D014481:United States / Q000453:epidemiology; D000069470:Venlafaxine Hydrochloride
chemical_list: D018687:Antidepressive Agents, Second-Generation; D003511:Cyclohexanols; D000069470:Venlafaxine Hydrochloride