Is Delamanid 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 Delamanid. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
Delamanid is not approved for marketing in the United States by the U.S. Food and Drug Administration, but is available in other countries. No information is available on the clinical use of delamanid during breastfeeding. Preliminary evidence indicates that delamanid and its active metabolite are present in milk at low levels. Delamanid is usually given with several other drugs for resistant tuberculosis, so the clinical importance of these small amounts is unclear.
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. The breastmilk of two patients receiving delamanid in unspecified doses had peak delamanid milk levels 4 hours after a dose. One had a peak delamanid milk level of about 200 mcg/L and a level of the active metabolite DM-6705 that was undetectable (<10 mcg/L) at all time points. The second woman had a peak delamanid level of about 700 mcg/L and a peak milk level of the active metabolite DM-6705 of about 40 mcg/L at 4 hours after the dose. Because the serum level of the first patient was also low, it was thought that her adherence to the regimen was poor.[1]
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 Delamanid 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 “Delamanid” (delamanid). 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.