Negligible exposure to nifurtimox through breast milk during maternal treatment for Chagas Disease.
PLoS Negl Trop Dis
; 13(8): e0007647, 2019 08.
Article
in En
| MEDLINE
| ID: mdl-31415566
ABSTRACT
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 ANDMETHODS:
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, 7th and 30th 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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Trypanocidal Agents
/
Chagas Disease
/
Milk, Human
/
Nifurtimox
Type of study:
Observational_studies
Limits:
Adolescent
/
Adult
/
Female
/
Humans
/
Infant
/
Male
Language:
En
Journal:
PLoS Negl Trop Dis
Journal subject:
MEDICINA TROPICAL
Year:
2019
Document type:
Article