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.

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.

• Authors: Facundo García-Bournissen, Samanta Moroni, Maria Elena Marson, Guillermo Moscatelli, Guido Mastrantonio, Margarita Bisio, Laura Cornou, Griselda Ballering, Jaime Altcheh
• Journal: Archives of disease in childhood (Arch Dis Child) Vol. 100 Issue 1 Pg. 90-4 (Jan 2015) ISSN: 1468-2044 [Electronic] England
• PMID: 25210104 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Chemical References

• Immunosuppressive Agents
• Nitroimidazoles
• benzonidazole

Topics

• Adult
• Breast Feeding
• Chagas Disease (drug therapy, metabolism)
• Chromatography, High Pressure Liquid
• Cohort Studies
• Female
• Humans
• Immunosuppressive Agents (pharmacokinetics)
• Infant
• Infant, Newborn
• Milk, Human (metabolism)
• Nitroimidazoles (pharmacokinetics)
• Prospective Studies
• Young Adult