Is Roflumilast safe while breastfeeding?
Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Roflumilast. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
No information is available on the use of roflumilast in nursing mothers. The drug and its metabolite are more than 97% bound to plasma proteins, so amounts in milk are likely to be very low. However, the manufacturer and some experts recommend that the oral drug should not be used by women who are nursing.[1] Topical products are unlikely to affect the infant but should be applied to the smallest area of skin and for the shortest duration possible while breastfeeding. To avoid direct infant exposure, do not apply roflumilast directly to the nipple or areola. If applied to the patient's chest, avoid exposure via direct contact with the infant's skin.
Effects on the breastfed infant
Relevant published information was not found as of the revision date.
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Maternal Levels. Relevant published information was not found as of the revision date.
Infant Levels. Relevant published information was not found as of the revision date.
“No published information” means the studies do not exist yet — not that Roflumilast is known to be harmful, and not that it is known to be safe. Your prescriber or pharmacist can weigh your baby's age and whether a better-studied alternative would do the same job. Worth asking before stopping a medicine you need.
Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Roflumilast” (roflumilast). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.