Original Articles
Congenital malformations after the use of inhaled budesonide in early pregnancy

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Abstract

Objective: To study possible teratogenic risks with the use of an inhaled glucocorticoid, budesonide, in early pregnancy.

Methods: Using the Swedish Medical Birth Registry, congenital malformations were studied in 2014 infants whose mothers had used inhaled budesonide for asthma in early pregnancy. The presence of congenital malformations was checked further with auxilliary registries.

Results: No increase in the general rate of congenital malformations was observed: 3.8% (95% confidence interval [CI] 2.9, 4.6) of the infants had a congenital malformation diagnosed, which is similar to the population rate (3.5%). After exposure to budesonide, four infants were born with orofacial clefts; this also is similar to the expected number (3.3).

Conclusion: Even though a specific teratogenic effect of use of budesonide in early pregnancy cannot be ruled out, it is unlikely that a clinically significant teratogenic risk exists.

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

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Financial support was provided by Astra-Draco, Lund, Sweden.

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