What is the data on using Category C inhaled corticosteroids in breastfeeding moms?


Thank you for your inquiry.

The best information regarding the use of Category C inhaled corticosteroids is contained in the package inserts of these drugs. I know of no interpretation that has superseded that offered by the Pharma company and approved by the FDA in these package inserts. For your convenience, I have copied below the sections dealing with the use of three Category C inhaled corticosteroids in nursing mothers. These steroids are fluticasone, mometasone, and beclomethasone.

Thank you again for your inquiry and we hope this response is helpful to you.

8.3 Nursing Mothers
It is not known whether fluticasone propionate is excreted in human breast milk. However, other corticosteroids have been detected in human milk. Subcutaneous administration to lactating rats of tritiated fluticasone propionate at a dose approximately 0.04 times the MRHDID for adults on a mg/m2 basis resulted in measurable radioactivity in milk.

Since there are no data from controlled trials on the use of FLOVENT DISKUS by nursing mothers, caution should be exercised when FLOVENT DISKUS is administered to a nursing woman.

8.3 Nursing Mothers
Systemic absorption of a single inhaled 400 mcg mometasone dose was less than 1%. It is not known if mometasone furoate is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be used when ASMANEX TWISTHALER is administered to nursing women.

Nursing Mothers: Corticosteroids are secreted in human milk. Because of the potential for serious adverse reactions in nursing infants from QVAR, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Phil Lieberman, M.D.

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