Is Clofazimine Safe in Breastfeeding
Question
I am a breastfeeding mother and i want to know if it is safe to use Clofazimine? Is Clofazimine safe for nursing mother and child? Does Clofazimine extracts into breast milk? Does Clofazimine has any long term or short term side effects on infants? Can Clofazimine influence milk supply or can Clofazimine decrease milk supply in lactating mothers?
Clofazimine lactation summary
- DrLact safety Score for Clofazimine is 3 out of 8 which is considered Low Risk as per our analyses.
- A safety Score of 3 indicates that usage of Clofazimine may cause some minor side effects in breastfed baby.
- Our study of different scientific research indicates that Clofazimine may cause moderate to no side effects in lactating mother.
- Most of scientific studies and research papers declaring usage of Clofazimine low risk in breastfeeding are based on normal dosage and may not hold true for higher dosage.
- While using Clofazimine We suggest monitoring child for possible reactions. It is also important to understand that side effects vary largely based on age of breastfed child and time of medication in addition to dosage.
- Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.
Answer by Dr. Ru: About Clofazimine usage in lactation
Reddish staining of milk and red-colored skin of infant, though reversible, are likely.
Answer by DrLact: About Clofazimine usage in 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 Side Effects in Breastfeeding
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.[4] 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.[5]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.[6]