Open AccessNegligible exposure to nifurtimox through breast milk during maternal treatment for Chagas Disease
Author(s) -
Samanta Moroni,
María Elena Marsón,
Guillermo Moscatelli,
Guido Mastrantonio,
Margarita Bisio,
Nicolás González,
Griselda Ballering,
Jaime Altcheh,
Facundo García-Bournissen
Publication year - 2019
Publication title -
plos neglected tropical diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.99
H-Index - 135
eISSN - 1935-2735
pISSN - 1935-2727
DOI - 10.1371/journal.pntd.0007647
Subject(s) - medicine , chagas disease , breast milk , breastfeeding , nifurtimox , breast feeding , prospective cohort study , adverse effect , interquartile range , lactation , obstetrics , physiology , pregnancy , pediatrics , trypanosoma cruzi , immunology , biology , parasite hosting , biochemistry , genetics , world wide web , computer science
Background Treatment with nifurtimox (NF) for Chagas disease is discouraged during breast-feeding because no information on NF transfer into breast milk is available. NF is safe and effective for paediatric and adult Chagas disease. We evaluated the degree of NF transfer into breast milk in lactating women with Chagas disease. Patients and methods Prospective study of a cohort of lactating women with Chagas disease. Patients were treated with NF for 1 month. NF was measured in plasma and milk by high performance liquid chromatography (HPLC). Breastfed infants were evaluated at admission, 7 th and 30 th day of treatment (and monthly thereafter, for 6 months). Results Lactating women with chronic Chagas disease (N = 10) were enrolled (median age 28 years, range 17–36). Median NF dose was 9.75 mg/kg/day three times a day (TID). Six mothers had mild adverse drug reactions (ADRs), but no ADRs were observed in any of the breastfed infants. No interruption of breastfeeding was observed. Median NF concentrations were 2.15 mg/L (Inter quartil range (IQR) 1.32–4.55) in milk and 0.30 mg/L (IQR 0.20–0.95) in plasma. Median NF milk/plasma ratio was 16 (range 8.75–30.25). Median relative infant NF dose (assuming a daily breastmilk intake of 150 mL/kg/day) was 6.7% of the maternal dose/kg/day (IQR 2.35–7.19%). Conclusions The low concentrations of NF in breast milk and the normal clinical evaluation of the breastfed babies imply that maternal NF treatment for Chagas disease during breastfeeding is unlikely to lead to clinically relevant exposures in the breastfed infants. Trial registration Clinical trial registry name and registration number: ClinicalTrials.gov NCT01744405 .