Abstract

Objectives: To investigate the risk of congenital malformations in infants born of women who had used antiasthmatic drugs in early pregnancy. Methods: Data were obtained from the Swedish Medical Birth Register for 1996-2011. Information on drug use was based on midwife interviews towards the end of the first trimester. Presence of congenital malformations was ascertained from three national health registers. Risk estimates were made with Mantel-Haenszel odds ratios after adjustment for delivery year, maternal age, parity, smoking, and body mass index. Consideration was taken to concomitantly used drugs. Results: Among more than 1.5 million women who gave birth, 2.9% reported the use of antiasthmatics. These women had characteristics which distinguished them from other women who gave birth and they more often than these used other drugs than antiasthmatics. These differences seemed to affect malformation risk only little. The risk for a major malformation was slightly but significantly increased (odds ratio=1.09, 95% confidence interval 1.03-1.12), specifically this was seen for cardiovascular defects, median cleft palate, and pyloric stenosis. There was no specific association with specific drugs or drug groups, the highest risk estimate was seen for women who used only one drug and notably a short-acting adrenergic or used three or more antiasthmatic drug groups. Conclusion: The absolute risk for a congenital malformation in infants born of women using antiasthmatics is low and some evidence indicates that it is due to underlying asthma. A good control of asthma seems important and scare of teratogenicity of the common antiasthmatic drugs should not prevent adequate use.

Highlights

  • Numerous studies have been published on the effect of maternal asthma on pregnancy and pregnancy outcome, including the presence of congenital malformations

  • The Medical Birth Register gave information on putative confounders consisting of maternal characteristics and of concomitant use of other drugs than antiasthmatics

  • When women who had used antiasthmatics together with systemic glucocorticosteroids were analyzed, the Odds Ratios (OR) for a relatively severe malformation was 0.81

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Summary

Introduction

Numerous studies have been published on the effect of maternal asthma on pregnancy and pregnancy outcome, including the presence of congenital malformations. Since further studies have appeared and recent reviews are available [2,3]. A meta-analysis in the latter article found a weighted total odds ratio for a major malformation from four relatively large cohort studies of 1.18 (95% CI 1.00-1.36). Other studies used case-control approaches [4,5,6] and found statistically significant associations between maternal use of antiasthmatics and specific congenital malformations. As pointed out by many authors [2], a major problem in the interpretation of these results is the question of confounding by indication, that the underlying asthma and not the use of drugs caused the malformations

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