Halofantrine Pregnancy and Breastfeeding Warnings

Brand names: Halfan

Halofantrine Pregnancy Warnings

Halofantrine has been assigned to pregnancy category C by the FDA. In rabbit studies, doses equivalent to 1.2 to 3.6 times the human dose were associated with skeletal malformations and abortion. Oral doses equivalent to 0.6 of the human dose did not cause maternal toxicity or fetotoxicity. In rats, oral doses equivalent to one-sixth of the human dose were associated with embryolethality and decreased fetal weight and viability. There are no controlled studies in human pregnancy. Halofantrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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Halofantrine Breastfeeding Warnings

There are no data on the excretion of halofantrine into human milk. In high-dose studies with rats, significant decreases in pup body weight and survival were observed. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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Further information

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