Budesonide Pregnancy and Breastfeeding Warnings
Budesonide Pregnancy Warnings
Oral budesonide has been assigned to pregnancy category C by the FDA. Inhaled budesonide has been assigned to pregnancy category B by the FDA. At high doses given subcutaneously, budesonide has been shown to be teratogenic in rabbits and rats. Budesonide has not been shown to be teratogenic in animals when given in high doses by inhalation. Despite the animal findings, it would appear that the possibility of fetal harm is remote if the inhaled drug is used during pregnancy. Nevertheless, because the studies in humans cannot rule out the possibility of harm, inhaled budesonide should be used during pregnancy only if clearly needed. Oral budesonide is only recommended for use in pregnancy when benefit outweighs risk.
The results from a large population-based prospective cohort epidemiological study reviewing data from three Swedish registries covering approximately 99% of the pregnancies from 1995-1997 indicate no increased risk for congenital malformations from the use of inhaled budesonide during early pregnancy. These same data were used in a second study bringing the total to 2,534 infants whose mothers were exposed to inhaled budesonide . In this study, the rate of congenital malformations among infants whose mother were exposed to inhaled budesonide during early pregnancy was not different from the rate for all newborn babies during the same period (3.6%).
Budesonide Breastfeeding Warnings
Budesonide, like other corticosteroids, is secreted in human milk. Data with budesonide delivered via dry powder inhaler indicates that the total daily oral dose of budesonide in breast milk to the infant is approximately 0.3% to 1% of the dose inhaled by the mother. The manufacturer recommends that caution be used when administering budesonide inhalation to nursing women. The maximum budesonide plasma concentration following a 9 mg daily dose (in both single and repeated dose pharmacokinetic studies) of oral budesonide is approximately 10 times higher than that for a 800 microgram daily dose of inhaled budesonide. Therefore, the manufacturer of oral budesonide recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the clinical importance of the drug to the mother.
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