Clofazimine Pregnancy and Breast Feeding Warnings

Clofazimine is also known as: Lamprene

Clofazimine Pregnancy Warnings

Clofazimine has been assigned to pregnancy category C by the FDA. While some animal studies have failed to reveal evidence of teratogenicity, studies done at high doses have demonstrated fetotoxicity. There are no controlled data in human pregnancy. Skin pigmentation has been noted in infants born to women treated with clofazimine during pregnancy. Clofazimine is only recommended during pregnancy when benefit outweighs risk.

In one reported case of clofazimine administration throughout gestation, hyperpigmentation was reported in the infant. In addition, the placenta showed signs of amnionitis. At two weeks, the infant was diagnosed with bilateral hydrocele and iron deficiency anemia. Another case of clofazimine use throughout pregnancy reported no complications.

Clofazimine Lactation Warnings

Clofazimine is excreted into human milk. Skin pigmentation is reported in at least one nursing infant. Clofazimine should not be used during breast-feeding unless necessary.

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