Original ArticlesCongenital malformations after the use of inhaled budesonide in early pregnancy☆
Section snippets
Material and methods
The Swedish Medical Birth Registry started in 1973 and covers practically all births in the country (approximately 100,000 per year). It is based on the use of standardized medical record forms in all delivery hospitals. Copies of documents from all antenatal care centers (nearly all pregnant women receive free antenatal care), from the delivery, and from the pediatric examination of the newborn are sent to the National Board of Health and are computerized.5 All liveborn infants are examined by
Results
A total of 2014 infants whose mothers stated the use of inhaled budesonide in early pregnancy were identified (27 of them were born in multiple births). Three hundred sixteen women used no other antiasthmatic drug. Of the remaining, the majority (n = 1675) also used a β2-stimulator, and a few used other inhaled glucocorticoids (n = 16).
Seventy-five infants (3.8%, 95% CI 2.9, 4.6) had a congenital malformation recorded in the Medical Birth Registry. Among all infants born in 1995–1997, the
Discussion
The present study could not identify any teratogenic properties of inhaled budesonide for which little previous information is available.
The information on drug use was collected prospectively relative to the identification of a congenital anomaly; therefore, the information cannot be biased by the outcome. It is likely, however, that all drug exposures were not recorded, but this should not affect the risk estimates. It is unlikely that a woman who reported the use of a specific drug did not
References (8)
- et al.
Production of congenital defects in offspring of female mice treated with cortisone
McGill Med J
(1950) Cleft palate produced in mice by human-equivalent dosage with triamcinolone
Science
(1965)Chemically induced birth defects
(1985)- et al.
Population-based case-control study of teratogenic potential of corticosteroids
Teratology
(1997)
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Financial support was provided by Astra-Draco, Lund, Sweden.