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Original article
Limited infant exposure to benznidazole through breast milk during maternal treatment for Chagas disease
  1. Facundo García-Bournissen1,
  2. Samanta Moroni1,
  3. Maria Elena Marson2,3,
  4. Guillermo Moscatelli1,
  5. Guido Mastrantonio2,3,
  6. Margarita Bisio1,
  7. Laura Cornou1,
  8. Griselda Ballering1,
  9. Jaime Altcheh1
  1. 1Parasitology and Chagas Service, Buenos Aires Children's Hospital “Dr Ricardo Gutierrez”, Buenos Aires, Argentina
  2. 2Toxicology Area, Biological Sciences Department/PlaPiMu-LaSeISiC, Faculty of Exact Sciences, National University of La Plata, La Plata, Buenos Aires, Argentina
  3. 3PlaPiMu—LaSeISiC, Buenos Aires Committee for Scientific Research, La Plata, Buenos Aires, Argentina
  1. Correspondence to Dr Facundo García-Bournissen, Parasitology and Chagas Service, Buenos Aires Children's Hospital “Dr Ricardo Gutierrez”, Gallo 1330, Buenos Aires 1425, Argentina; facugb{at}hotmail.com

Abstract

Background Benznidazole (BNZ) is safe and effective for the treatment of paediatric Chagas disease. Treatment of adults is also effective in many cases, but discouraged in breastfeeding women because no information on BNZ transfer into breast milk is available. We aimed to evaluate the degree of BNZ transfer into breast milk in lactating women with Chagas disease.

Patients and methods Prospective cohort study of lactating women with Chagas disease treated with BNZ administered for 30 days. Patients and their breastfed infants were evaluated at admission, the 7th and 30th day of treatment (and monthly thereafter, for 6 months). BNZ was measured in plasma and milk by high performance liquid chromatography. The protocol was registered in ClinicalTrials.gov (#NCT01547533).

Results 12 lactating women with chronic Chagas disease were enrolled (median age 28.5 years, range 20–34). Median BNZ dose was 5.65 mg/kg/day twice daily. Five mothers had adverse drug events (45%), but no adverse drug reactions or any untoward outcomes were observed in the breastfed infants. Median milk BNZ concentration was 3.8 mg/L (range 0.3–5.9) and 6.26 mg/L (range 0.3–12.6) in plasma. Median BNZ milk to plasma ratio was 0.52 (range 0.3–2.79). Median relative BNZ dose received by the infant (assuming a daily breast milk intake of 150 mL/kg/day) was 12.3% of the maternal dose per kg (range 5.5%–17%).

Conclusions The limited transference of BNZ into breast milk and the reassuring normal clinical evaluation of the breastfed babies suggest that maternal BNZ treatment for Chagas disease during breast feeding is unlikely to present a risk for the breastfed infant.

Trial registration number ClinicalTrials.gov NCT01547533.

  • Chagas disease
  • breastfeeding
  • benznidazole
  • pediatric clinical pharmacology

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