Budesonide Pregnancy and Breast Feeding Warnings
Budesonide is also known as: Entocort, Entocort EC, Pulmicort Flexhaler, Pulmicort Nebuamp, Pulmicort Respules, Pulmicort Turbuhaler
Overview
If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Budesonide Sustained-Release Capsules while you are pregnant. Budesonide Sustained-Release Capsules is found in breast milk. Do not breast-feed while taking Budesonide Sustained-Release Capsules.
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 Lactation 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 to nursing women.
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