Limited infant exposure to benznidazole through breast milk during maternal treatment for Chagas disease

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...

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Autores principales: García Bournissen, Facundo, Moroni, Samanta, Marson, María Elena, Moscatelli, Guillermo, Mastrantonio Garrido, Guido Enrique, Bisio, Margarita, Cornou, Laura, Ballering, Griselda, Altcheh, Jaime
Formato: Articulo
Lenguaje:Inglés
Publicado: 2014
Materias:
Ciencias Médicas
Acceso en línea:http://sedici.unlp.edu.ar/handle/10915/167266
Aporte de:
SEDICI (UNLP) de Universidad Nacional de La Plata
id I19-R120-10915-167266
record_format dspace
spelling I19-R120-10915-1672662024-06-15T04:08:14Z http://sedici.unlp.edu.ar/handle/10915/167266 Limited infant exposure to benznidazole through breast milk during maternal treatment for Chagas disease García Bournissen, Facundo Moroni, Samanta Marson, María Elena Moscatelli, Guillermo Mastrantonio Garrido, Guido Enrique Bisio, Margarita Cornou, Laura Ballering, Griselda Altcheh, Jaime 2014-09-10 2024-06-14T14:38:01Z en Ciencias Médicas 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. Facultad de Ciencias Médicas Articulo Articulo http://creativecommons.org/licenses/by-nc-sa/4.0/ Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0) application/pdf
institution Universidad Nacional de La Plata
institution_str I-19
repository_str R-120
collection SEDICI (UNLP)
language Inglés
topic Ciencias Médicas
spellingShingle Ciencias Médicas
García Bournissen, Facundo
Moroni, Samanta
Marson, María Elena
Moscatelli, Guillermo
Mastrantonio Garrido, Guido Enrique
Bisio, Margarita
Cornou, Laura
Ballering, Griselda
Altcheh, Jaime
Limited infant exposure to benznidazole through breast milk during maternal treatment for Chagas disease
topic_facet Ciencias Médicas
description 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.
format Articulo
Articulo
author García Bournissen, Facundo
Moroni, Samanta
Marson, María Elena
Moscatelli, Guillermo
Mastrantonio Garrido, Guido Enrique
Bisio, Margarita
Cornou, Laura
Ballering, Griselda
Altcheh, Jaime
author_facet García Bournissen, Facundo
Moroni, Samanta
Marson, María Elena
Moscatelli, Guillermo
Mastrantonio Garrido, Guido Enrique
Bisio, Margarita
Cornou, Laura
Ballering, Griselda
Altcheh, Jaime
author_sort García Bournissen, Facundo
title Limited infant exposure to benznidazole through breast milk during maternal treatment for Chagas disease
title_short Limited infant exposure to benznidazole through breast milk during maternal treatment for Chagas disease
title_full Limited infant exposure to benznidazole through breast milk during maternal treatment for Chagas disease
title_fullStr Limited infant exposure to benznidazole through breast milk during maternal treatment for Chagas disease
title_full_unstemmed Limited infant exposure to benznidazole through breast milk during maternal treatment for Chagas disease
title_sort limited infant exposure to benznidazole through breast milk during maternal treatment for chagas disease
publishDate 2014
url http://sedici.unlp.edu.ar/handle/10915/167266
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