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National Birth Defects Prevention Study

Krista S. Crider, PhD; Mario A. Cleves, PhD; Jennita Reefhuis, PhD; Robert J. Berry, MD; Charlotte A. Hobbs, MD; Dale J. Hu, MD

Arch Pediatr Adolesc Med. 2009;163(11):978-985.

Objective  To estimate the association between antibacterial medications and selected birth defects.

Design, Setting, and Participants  Population-based, multisite, case-control study of women who had pregnancies affected by 1 of more than 30 eligible major birth defects identified via birth defect surveillance programs in 10 states (n = 13 155) and control women randomly selected from the same geographical regions (n = 4941).

Main Exposure  Reported maternal use of antibacterials (1 month before pregnancy through the end of the first trimester).

Main Outcome Measure  Odds ratios (ORs) measuring the association between antibacterial use and selected birth defects adjusted for potential confounders.

Results  The reported use of antibacterials increased during pregnancy, peaking during the third month. Sulfonamides were associated with anencephaly (adjusted OR [AOR] = 3.4; 95% confidence interval [CI], 1.3-8.8), hypoplastic left heart syndrome (AOR = 3.2; 95% CI, 1.3-7.6), coarctation of the aorta (AOR = 2.7; 95% CI, 1.3-5.6), choanal atresia (AOR = 8.0; 95% CI, 2.7-23.5), transverse limb deficiency (AOR = 2.5; 95% CI, 1.0-5.9), and diaphragmatic hernia (AOR = 2.4; 95% CI, 1.1-5.4). Nitrofurantoins were associated with anophthalmia or microphthalmos (AOR = 3.7; 95% CI, 1.1-12.2), hypoplastic left heart syndrome (AOR = 4.2; 95% CI, 1.9-9.1), atrial septal defects (AOR = 1.9; 95% CI, 1.1-3.4), and cleft lip with cleft palate (AOR = 2.1; 95% CI, 1.2-3.9). Other antibacterial agents that showed associations included erythromycins (2 defects), penicillins (1 defect), cephalosporins (1 defect), and quinolones (1 defect).

Conclusions  Reassuringly, penicillins, erythromycins, and cephalosporins, although used commonly by pregnant women, were not associated with many birth defects. Sulfonamides and nitrofurantoins were associated with several birth defects, indicating a need for additional scrutiny.

Author Affiliations: Division of Birth Defects and Developmental Disabilities, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, Georgia (Drs Crider, Reefhuis, Berry, and Hu); and Department of Pediatrics, College of Medicine, University of Arkansas for Medical Sciences, Little Rock (Drs Cleves and Hobbs).

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