Is Clofazimine 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 Clofazimine. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
Limited information indicates that clofazimine appears in milk in relatively large amounts. Human milk enhances the solubilization and possibly the absorption of clofazimine in infants.[1,2] Milk can be colored pink to red by the drug and breastfed infant's skin can be discolored the typical red color that is common in persons taking the drug.[3-5] No serious or permanent toxicity has been reported in breastfed infants; however, an alternate drug might be considered.
Effects on the breastfed infant
Probable cases of skin discoloration in breastfed infants whose mothers were taking clofazimine have been reported. In one infant, red skin color was reported.[1] In another (exact maternal dosage not stated, but in the range of 100 to 300 mg daily), the infant's skin color was reported as ruddy and slightly hypermelanotic; this infant's skin color returned to normal 5 months after the end of maternal therapy.[5]
Clofazimine was used as part of a six-drug regimen to treat a pregnant woman with multidrug-resistant tuberculosis during the first trimester of pregnancy and postpartum. The infant was breastfed (extent and duration not stated). At age 1.8 years, the child had failure to thrive, possibly due to tuberculosis contracted after birth, but was otherwise developing normally. The child also had bronze coloration of the skin color which faded over time.[7]
A woman with leprosy took clofazimine, dapsone and rifampin during pregnancy and breastfeeding. Her infant developed skin discoloration attributed to clofazimine which reversed 3 months after cessation of breastfeeding.[8]
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Maternal Levels. Eight women with leprosy who had been breastfeeding for 4 months or less had been receiving clofazimine either 50 mg daily (n = 5), 100 mg every other day (n = 2) or 100 mg daily (n = 1) for an average of 5 months. Milk levels collected 4 to 6 hours after the dose averaged 1.33 mg/L (range 0.8 to 1.7 mg/L). Infants received an average of 0.199 mg/kg daily (range 0.17 to 0.26 mg/kg daily) which averaged 22.1% (range 13.5 to 30%) of the maternal weight-adjusted dosage.[6]
Infant Levels. Relevant published information was not found as of the revision date.
Alternatives LactMed lists
Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Clofazimine” (LM430). 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.