Animal reproduction studies in mice, rats, and rabbits revealed evidence of teratogenicity, such as increased fetal malformations and decreased fetal growth (measured by lower fetal weights and/or delayed ossification). Dystocia and related complications were also observed when administered in late gestation. In mice, subcutaneous administration produced cleft palate at approximately one-third of the maximum recommended daily human dose (MRHD). In rats, topical administration produced umbilical hernia at doses approximately 6 times the MRHD. Subcutaneous administration in rats, throughout pregnancy or late in gestation, had caused prolonged and difficult labor, fewer live births, lower birth weight, and reduced early pup survival at doses approximately 8 times the MRHD. In rabbits, topical administration caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at doses approximately 3 times the MRHD. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned


Comments:
-Hypoadrenalism may occur in infants born to women receiving corticosteroids during pregnancy.
-Monitor signs of hypoadrenalism in infants born to mothers taking substantial corticosteroid doses during pregnancy.
-Women with poorly controlled asthma are at increased risk of adverse perinatal outcomes such as maternal preeclampsia, and prematurity, low birth weight, and small for gestational age children.

See references

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-The effects in the nursing infant and on lactation are unknown.
-Other similar inhaled corticosteroids are present in human milk.
-Consider the developmental and health benefits of breastfeeding along with the mothers clinical need for this medication and any potential adverse effects on the child from the medication or the underlying maternal condition.

See references