Risk of congenital anomalies in pregnant users of non-steroidal anti-inflammatory drugs: a nested case-control study
Benjamin Ofori, Driss Oraichi, Lucie Blais, Evelyne Rey, Anick Bérard 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. Benjamin Ofori 1, Driss Oraichi 1, Lucie Blais 2, Evelyne Rey 3, Anick Bérard 1Research Center, Sainte-Justine Hospital, Montreal, Quebec, Canada 2Faculty of Pharmacy, University of Montreal, Pavillon Jean-Coutu, Montreal, Quebec, Canada 3Faculty of Medicine, University of Montreal, Pavillon Roger-Gaudry, Montreal, Quebec, Canada
