Document Detail

Is use of nifurtimox for the treatment of Chagas disease compatible with breast feeding? A population pharmacokinetics analysis.
MedLine Citation:
PMID:  19948512     Owner:  NLM     Status:  MEDLINE    
INTRODUCTION: Women with Chagas disease receiving treatment with nifurtimox are discouraged from breast feeding. Many patients who would receive treatment with nifurtimox live in extreme poverty, have limited access to resources such as clean water and baby formula and may not have safe alternatives to breast milk.
AIM: We aimed to estimate, using limited available pharmacokinetics data, potential infant exposure to nifurtimox through breast milk.
METHODS: Original nifurtimox plasma concentrations were obtained from published studies. Pharmacokinetic parameters were estimated using non-linear mixed-effect modelling with NONMEM V.VI. A total of 1000 nifurtimox plasma-concentration profiles were simulated and used to calculate the amount of drug that an infant would be exposed to, if breast fed 150 ml/kg/day.
RESULTS: Breast milk concentrations on the basis of peak plasma levels (1361 ng/ml) and milk-plasma ratio were estimated. We calculated infant nifurtimox exposure of a breastfed infant of a mother treated with this drug to be below 10% of the maternal weight-adjusted dose, even if milk-plasma ratio were overestimated. Simulation led to similar estimates.
DISCUSSION: Risk for significant infant exposure to nifurtimox through breast milk seems small and below the level of exposure of infants with Chagas disease receiving nifurtimox treatment. This potential degree of exposure may not justify discontinuation of breast feeding.
Facundo Garcia-Bournissen; Jaime Altcheh; Alice Panchaud; Shinya Ito
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2009-11-29
Journal Detail:
Title:  Archives of disease in childhood     Volume:  95     ISSN:  1468-2044     ISO Abbreviation:  Arch. Dis. Child.     Publication Date:  2010 Mar 
Date Detail:
Created Date:  2010-03-23     Completed Date:  2010-12-22     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372434     Medline TA:  Arch Dis Child     Country:  England    
Other Details:
Languages:  eng     Pagination:  224-8     Citation Subset:  AIM; IM    
Division of Clinical Pharmacology and Toxicology, Hospital for Sick Children, University of Toronto, 555 University Avenue, 8th Floor, Black Wing, Room 8232, Toronto, ON M5G 1X8, Canada.
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MeSH Terms
Breast Feeding*
Chagas Disease / blood,  drug therapy*
Infant, Newborn
Milk, Human / metabolism*
Nifurtimox / blood,  pharmacokinetics*
Risk Assessment / methods
Trypanocidal Agents / blood,  pharmacokinetics*
Reg. No./Substance:
0/Trypanocidal Agents; 23256-30-6/Nifurtimox

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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