Association between reported venlafaxine use in early pregnancy and birth defects, national birth defects prevention study, 1997–2007

Authors

  • Kara N. D. Polen,

    Corresponding author
    1. National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, Georgia
    • National Center on Birth Defects and Developmental Disabilities, 1600 Clifton Road, MS E-86, Atlanta, GA 30333
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  • Sonja A. Rasmussen,

    1. National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, Georgia
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  • Tiffany Riehle-Colarusso,

    1. National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, Georgia
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  • Jennita Reefhuis,

    1. National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, Georgia
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  • and the National Birth Defects Prevention Study


  • This work was supported through 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.

    Presented at the 23rd Annual Meeting of the Society for Pediatric and Perinatal Epidemiologic Research, Seattle, Washington, June 23–24, 2010, the 43rd Annual Meeting of the Society for Epidemiologic Research, Seattle, Washington, June 21–24, 2010, the 50th Annual Meeting of the Teratology Society, Louisville, Kentucky, June 26–30, 2010, the 31st Annual David W. Smith Workshop on Malformations and Morphogenesis, Union, Washington, August 27–September 1, 2010, and the 27th International Conference on Pharmacoepidemiology and Therapeutic Risk Management, Chicago, Illinois, August 14–17, 2011.

    Disclaimer: 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.

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. Birth Defects Research (Part A), 2013. © 2012 Wiley Periodicals, Inc.

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