Fluticasone Pregnancy and Breastfeeding Warnings

Brand names: ArmonAir Digihaler, ArmonAir RespiClick, Arnuity Ellipta, Flovent, Flovent Diskus, Flovent HFA, Flovent Rotadisk

Medically reviewed by Drugs.com. Last updated on Mar 21, 2024.

Fluticasone Pregnancy Warnings

Use is not recommended unless the benefit outweighs the risk to the fetus

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

Comments:
-Pregnant women with asthma should be closely monitored to maintain optimal asthma control.
-Hypoadrenalism may occur in neonates exposed to glucocorticosteroids in utero; carefully observe neonates for signs and symptoms of hypoadrenalism.
-There is insufficient data on use in pregnancy.

Animal studies have shown teratogenicity typical of corticosteroids (decreased fetal body weight and/or skeletal variations) with subcutaneously administered doses of this drug. Rats dosed via inhalation have shown decreased fetal body weight, but teratogenicity was not observed. Epidemiologic data of other inhaled corticosteroids have not demonstrated these effects in animals to occur in humans. Women with poorly or moderately controlled asthma have shown an increased risk of pre-eclampsia, and there has been an increased incidence of prematurity, low birth weight, and small for gestational age events observed in their babies. There are no adequate and well controlled studies in pregnant women. Fluticasone was detected in neonatal cord blood after drug inhalation by the parent.

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.

See references

Fluticasone Breastfeeding Warnings

Benefit should outweigh risk

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

Comment: Inhaled corticosteroids are generally considered acceptable to use during breastfeeding as the amount, if excreted into breastmilk, would probably be too small to affect a breastfed infant.

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

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer