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Flunisolide Pregnancy and Breastfeeding Warnings

Flunisolide is also known as: Aerobid, Aerobid-M, Aerospan HFA

Flunisolide Pregnancy Warnings

Flunisolide has been assigned to pregnancy category C by the FDA. At high doses, flunisolide has been shown to be teratogenic in rabbits and rats. There are no controlled data in human pregnancy. Flunisolide is only recommended for use during pregnancy when benefit outweighs risk.

In a review of 229,101 deliveries to Michigan Medicaid patients, 141 first-trimester exposures to flunisolide and 322 exposures anytime during pregnancy were recorded. A total of 5 birth defects were reported with first-trimester exposures (5 expected). (written communication, Franz Rosa, MD, Food and Drug Administration, 1994) These data do not support an association with adverse fetal outcome.

Flunisolide Breastfeeding Warnings

There are no data on the excretion of flunisolide into human milk. Other glucocorticoids are excreted into human milk in low concentrations. The manufacturer recommends that caution be use when administering flunisolide to nursing women.

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