Clofazimine use while Breastfeeding
Drugs containing Clofazimine: Lamprene
Clofazimine Levels and Effects while Breastfeeding
Summary of Use during Lactation
Limited information indicates that clofazimine appears in milk in relatively large amounts. Milk can be colored pink by the drug and breastfed infant's skin can be discolored the typical red color that is common in persons taking the drug. No serious or permanent toxicity has been reported in breastfed infants; however, an alternate drug might be considered.
Clofazimine is excreted into milk, reportedly coloring it bright pink to red.
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.
Infant Levels. Relevant published information was not found as of the revision date.
Effects in Breastfed Infants
Probable cases of skin discoloration in breastfed infants whose mothers were taking clofazimine have been reported. In one infant, red skin color was reported. 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.
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.
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. Her previous child had a similar discoloration from breastfeeding with maternal clofazimine. Both infants were reportedly healthy.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Alternate Drugs to Consider
1. Waters MFR. G 30 320 or B 663--Lampren (Geigy). A working party held at the Royal Garden Hotel London, September 1968. Lepr Rev. 1969;40 (1):21-47. PMID: 4888382
2. Freerksen E, Seydel JK. Critical comments on the treatment of leprosy and other mycobacterial infections with clofazimine. Arzneimittelforschung. 1992;42:1243-5. PMID: 1472145
3. Venkatesan K, Mathur A, Girdhar A et al. Excretion of clofazimine in human milk in leprosy patients. Lepr Rev. 1997;68:242-6. PMID: 9364825
4. Browne SG, Hogerzeil LM. "B 663" in the treatment of leprosy: preliminary report of a pilot trial. Lepr Rev. 1962;33:6-10. PMID: 13873759
5. Drobac PC, del Castillo H, Sweetland A et al. Treatment of multidrug-resistant tuberculosis during pregnancy: long-term follow-up of 6 children with intrauterine exposure to second-line agents. Clin Infect Dis. 2005;40:1689-92. PMID: 15889370
6. Ozturk Z. Hansen's disease during pregnancy and lactation: Two babies born to a mother using antileprosy drugs. Naunyn-Schmiedeberg's Arch Pharmacol. 2016;389:S94-S95. Abstract. DOI: doi:10.1007/s00210-016-1213-y
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