Budesma Use In Pregnancy & Lactation

Pregnancy: US FDA Pregnancy Category B: Data on approximately 2,000 exposed pregnancies indicate no increased teratogenic risk associated with the use of inhaled budesonide. In animal studies, glucocorticosteroids have been shown to induce malformations (Refer to Pharmacology: Toxicology: Carcinogenesis, Mutagenesis and Impairment of Fertility under Actions).
This is not likely to be relevant for humans at the given recommended doses, but therapy with inhaled budesonide should be regularly reviewed and maintained at the lowest effective dose.
Budesonide should be administered only after weighing the potential benefits of the therapy against the potential risks to the mother and the fetus.
Inhaled glucocorticoids should be considered in preference to oral glucocorticoids because of the lower systemic effects at the doses required to achieve similar pulmonary responses. The general consensus view is that the management of asthma in pregnant patients should be the same as that of non-pregnant patients, and that poor oxygenation due to uncontrolled asthma represents a greater danger to the fetus than any potential harm associated with the drugs used to treat the disease. Asthma in pregnant women is generally treated with the same agents and regimens as in non-pregnant women with asthma. Infants of mothers treated with corticosteroids during pregnancy should be carefully monitored for hypoadrenalism.
Lactation: No reports describing the use of Budesonide during human lactation are available and the effects on the nursing infant from exposure to the drug in milk are unknown. The use of Budesonide, in nursing mothers, warrants caution because other corticosteroids are known to enter breast milk and it is assumed that Budesonide does so as well.