title: Limited infant exposure to benznidazole through breast milk during maternal treatment for Chagas disease.
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.
  
  
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01547533.
authors.affiliation: Parasitology and Chagas Service, Buenos Aires Children's Hospital "Dr Ricardo Gutierrez", Buenos Aires, Argentina.
authors.forename: Facundo
authors.initials: F
authors.lastname: García-Bournissen
authors.affiliation: Parasitology and Chagas Service, Buenos Aires Children's Hospital "Dr Ricardo Gutierrez", Buenos Aires, Argentina.
authors.forename: Samanta
authors.initials: S
authors.lastname: Moroni
authors.affiliation: Toxicology Area, Biological Sciences Department/PlaPiMu-LaSeISiC, Faculty of Exact Sciences, National University of La Plata, La Plata, Buenos Aires, Argentina PlaPiMu-LaSeISiC, Buenos Aires Committee for Scientific Research, La Plata, Buenos Aires, Argentina.
authors.forename: Maria Elena
authors.initials: ME
authors.lastname: Marson
authors.affiliation: Parasitology and Chagas Service, Buenos Aires Children's Hospital "Dr Ricardo Gutierrez", Buenos Aires, Argentina.
authors.forename: Guillermo
authors.initials: G
authors.lastname: Moscatelli
authors.affiliation: Toxicology Area, Biological Sciences Department/PlaPiMu-LaSeISiC, Faculty of Exact Sciences, National University of La Plata, La Plata, Buenos Aires, Argentina PlaPiMu-LaSeISiC, Buenos Aires Committee for Scientific Research, La Plata, Buenos Aires, Argentina.
authors.forename: Guido
authors.initials: G
authors.lastname: Mastrantonio
authors.affiliation: Parasitology and Chagas Service, Buenos Aires Children's Hospital "Dr Ricardo Gutierrez", Buenos Aires, Argentina.
authors.forename: Margarita
authors.initials: M
authors.lastname: Bisio
authors.affiliation: Parasitology and Chagas Service, Buenos Aires Children's Hospital "Dr Ricardo Gutierrez", Buenos Aires, Argentina.
authors.forename: Laura
authors.initials: L
authors.lastname: Cornou
authors.affiliation: Parasitology and Chagas Service, Buenos Aires Children's Hospital "Dr Ricardo Gutierrez", Buenos Aires, Argentina.
authors.forename: Griselda
authors.initials: G
authors.lastname: Ballering
authors.affiliation: Parasitology and Chagas Service, Buenos Aires Children's Hospital "Dr Ricardo Gutierrez", Buenos Aires, Argentina.
authors.forename: Jaime
authors.initials: J
authors.lastname: Altcheh
mesh_terms: D000328:Adult; D001942:Breast Feeding; D014355:Chagas Disease / Q000188:drug therapy / Q000378:metabolism*; D002851:Chromatography, High Pressure Liquid; D015331:Cohort Studies; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000493:pharmacokinetics*; D007223:Infant; D007231:Infant, Newborn; D008895:Milk, Human / Q000378:metabolism*; D009593:Nitroimidazoles / Q000493:pharmacokinetics*; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D009593:Nitroimidazoles; C009999:benzonidazole
keywords: Chagas disease; benznidazole; breastfeeding; pediatric clinical pharmacology