Original Article

Risk of congenital anomalies in pregnant users of non-steroidal anti-inflammatory drugs: a nested case-control study†

  1. Benjamin Ofori1,
  2. Driss Oraichi1,
  3. Lucie Blais2,
  4. Evelyne Rey3,
  5. Anick Bérard1,*

Article first published online: 23 AUG 2006

DOI: 10.1002/bdrb.20085

Issue

Birth Defects Research Part B: Developmental and Reproductive Toxicology

Birth Defects Research Part B: Developmental and Reproductive Toxicology

Volume 77, Issue 4, pages 268–279, August 2006

Additional Information

How to Cite

Ofori, B., Oraichi, D., Blais, L., Rey, E. and Bérard, A. (2006), Risk of congenital anomalies in pregnant users of non-steroidal anti-inflammatory drugs: a nested case-control study. Birth Defects Research Part B: Developmental and Reproductive Toxicology, 77: 268–279. doi: 10.1002/bdrb.20085

Author Information

  1. 1

    Research Center, Sainte-Justine Hospital, Montreal, Quebec, Canada

  2. 2

    Faculty of Pharmacy, University of Montreal, Pavillon Jean-Coutu, Montreal, Quebec, Canada

  3. 3

    Faculty of Medicine, University of Montreal, Pavillon Roger-Gaudry, Montreal, Quebec, Canada

*Sainte-Justine Hospital, Research Center 3175, chemin de la Côte-Ste-Catherine, Montréal, Quebec H3T 1C5, Canada

  1. †

    The design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript was completely independent of the sponsor.

Publication History

  1. Issue published online: 21 SEP 2006
  2. Article first published online: 23 AUG 2006
  3. Manuscript Accepted: 8 JUL 2006
  4. Manuscript Received: 29 MAY 2006

Funded by

  • Les Fonds de la Recherche en Santédu Québec (FRSQ)
  • The Réseau Québécois de recherche sur l'usage des médicaments (RQRUM)
  • Réseau FRSQ for the Wellbeing of Children

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Keywords:

  • non-steroidal anti-inflammatory drugs (NSAIDs);
  • pregnancy;
  • congenital anomalies;
  • cardiac septal closure anomalies;
  • pregnancy registry

Abstract

BACKGROUND: Many women take non-steroidal anti-inflammatory drugs (NSAIDs) during pregnancy but the risks for the infant remain controversial. We carried out a study to quantify the association between those women prescribed NSAIDs in early pregnancy and congenital anomalies. METHODS: A population-based pregnancy registry was built by linking data from three administrative databases in Quebec between 1997–2003. The inclusion criteria were mothers of live singleton infants, between 15–45 years of age, covered by the RAMQ drug plan ≥12 months before and during pregnancy, and prescribed an NSAID or other medications during pregnancy. We selected as cases infants with any congenital anomaly (ICD-9; 740-759) diagnosed in the first year of life. Up to 10 controls, defined as infants with no congenital anomalies detected were selected for each case. Adjusted odds ratios (OR) and 95% confidence intervals (CI) were estimated. RESULTS: Within the registry, 36,387 pregnant women met the inclusion criteria. We identified 93 births with congenital anomalies in 1056 women (8.8%) who filled prescriptions for NSAIDs in the first trimester of pregnancy, compared to 2478 in 35,331 (7%) women who did not. The adjusted OR for any congenital anomalies for women who filled a prescription for NSAIDs in the first trimester was 2.21 (95% CI=1.72–2.85). The adjusted OR for the anomalies related to cardiac septal closure was 3.34 (95% CI=1.87–5.98). There were no significant associations with anomalies of other major organ systems. CONCLUSIONS: Our study suggests that women prescribed NSAIDs during early pregnancy may be at a greater risk of having children with congenital anomalies, specifically cardiac septal defects. Birth Defects Research (Part B), 2006. © 2006 Wiley-Liss, Inc.

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