Is Nifurtimox safe while breastfeeding?

Here is what NIH LactMed, the U.S. National Library of Medicine's authority on medicines and breastfeeding, reports about Nifurtimox. This is a summary of that source — not our own verdict.

Effects on the breastfed infant

A cohort of 33 infants who were breastfed (extent not stated) by hospitalized mothers taking nifurtimox was followed in the Democratic Republic of the Congo. Thirty mothers took a full course of 30 doses of oral nifurtimox 15 mg/kg daily and all received 14 doses of intravenous eflornithine 400 mg/kg daily for 7 days for human African trypanosomiasis. (sleeping sickness). Nursing mothers also took a median of 4 other concomitant medications, including amoxicillin, ciprofloxacin, metronidazole, trimethoprim-sulfamethoxazole, aspirin, and diclofenac (1 patient each); hydrocortisone, promethazine and quinine (2 patients each); levamisole (6 patients); sulfadoxine-pyrimethamine (8 patients); dipyrone (13 patients); acetaminophen (16 patients); and mebendazole (17 patients). No serious adverse events were reported in any of the breastfed infants.[ 6 - 8 ]

Effects on milk supply

Relevant published information was not found as of the revision date.

Levels in milk

Maternal Levels. A computer simulation using pharmacokinetic data from adults and assuming milk-plasma ratios of 1 resulted in an estimated median infant dose of 0.19% of the maternal weight-adjusted dosage. Assuming milk-plasma ratios of 6 resulted in an estimated maximum infant dose of 3.1% of the maternal weight-adjusted dosage.[ 3 ] Four women with Chagas disease were treated with nifurtimox 10 to 15 mg/kg daily in 3 divided doses provided breastmilk samples for analysis after 4 to 10 days of therapy. The timing of the sample with respect to doses was not reported. Breastmilk concentrations of nifurtimox ranged from nonquantifiable ( 0.55 mg/L) to 8.2 mg/L.[ 4 ] Ten women were receiving a median dose of nifurtimox of 9.75 mg/kg daily donated 1 or 2 milk samples at various times after a dose at steady state. The median nifurtimox concentration in milk was 2.15 mg/L (interquartile range 1.32 to 4.55 mg/L). The authors estimated that infants would receive a median daily dosage of 0.5 mg/kg, which is equal to a median weight-adjusted maternal dose of 6.7% (interquartile range 2.35 to 7.19%).[ 5 ] Infant Levels. Relevant published information was not found as of the revision date.

Source: NIH LactMed (National Library of Medicine).

Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.