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Clofazimine Pregnancy and Breastfeeding Warnings

Brand names: 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.

See references

Clofazimine Breastfeeding 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.

See references

See also

References for pregnancy information

  1. Farb H, West DP, Pedvis-Leftick A (1982) "Clofazimine in pregnancy complicated by leprosy." Obstet Gynecol, 59, p. 122-3
  2. (2002) "Product Information. Lamprene (clofazimine)." Novartis Pharmaceuticals

References for breastfeeding information

  1. (2002) "Product Information. Lamprene (clofazimine)." Novartis Pharmaceuticals

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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