Corticosteroids have been shown to be teratogenic in rats and mice with subcutaneous administration throughout organogenesis; at a maternotoxic fluticasone dose about 5 times the maximum recommended human daily intranasal dose (MRHDID) omphalocele, decreased weight, and skeletal malformations were seen in rats. The no observed adverse effect level (NOAEL) in rats is about equal to the MRHDID. At the equivalent MRHDID dose cleft palate and skeletal variations were seen in mice. The mouse NOAEL is about 0.3 times the MRHDID. Rats dosed by intranasal inhalation only throughout organogenesis had decreased body weight and skeletal variations at doses equivalent to the MRHDID (a maternotoxic dose). Rabbits given 0.06 times the MRHDID (a maternotoxic dose) subcutaneously during organogenesis had decreased pup weight; cleft palate occurred at 0.39 times the MRHDID but not teratogenicity, the NOAEL was about 0.01 times the MRHDID. Fluticasone crossed the placenta after oral and subcutaneous administration in rodents. Rats dosed at up to 2 times the MRHDID from late gestation (gestation day 17) through lactation (day 22 postpartum) showed no effect on pup weight, developmental landmarks, learning, memory, reflexes or fertility. There are no adequate studies in pregnant women. Fluticasone was detected in neonatal cord blood after drug inhalation by the parent. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.


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

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

Comments:
-There is insufficient data on use in pregnant women to know this drugs risks.
-Animal studies showed characteristic corticosteroid teratogenicity (decreased fetal weight and/or skeletal malformations) at maternotoxic doses of fluticasone [5 times, equal to, and under the maximum recommended human daily intranasal dose (MRHDID)].
-Intranasal inhalation of a dose equivalent to the MRHDID (a maternotoxic dose) decreased fetal weights in rats but showed no teratogenicity.
-Oral corticosteroid experience suggests rodents are more prone to corticosteroid teratogenic effects than humans.
-Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy.

See references

Benefit should outweigh risk.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Other steroids have been detected in low concentrations in human milk.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

Measurable milk levels were seen after subcutaneous administration of 10 mcg/kg/day of titrated fluticasone propionate to lactating rats.

See references