This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: A
US FDA pregnancy category: Not assigned

Comments:
-Long term corticosteroid treatment may lead to suppression of the adrenal cortex in the newborn.
-Short term antepartum use for respiratory distress syndrome prevention does not seem to pose a fetal or newborn risk.
-Corticosteroids may inhibit uterine contraction and lead to maternal fluid overload.

Animal studies showed various malformations (cleft palate, skeletal malformations) and abortions; these findings do not appear to be relevant to humans. Reduced placental and birth weights have been reported in animals and humans with long term corticosteroid treatment. There are no controlled data in human pregnancy.

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.


US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Yes

Comments:
-Corticosteroids from breast milk could suppress growth and affect endogenous production of corticosteroids among other adverse effects.
-Advise patients on pharmacologic corticosteroids not to nurse.

See references