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Potential long-term toxicity of repeated orally administered doses of artemether in rats.

Abstract
Artemether, an efficacious antimalarial drug, effectively prevents patent schistosome infections and morbidity, as established in laboratory models and in clinical trials. In view of concern about the potential long-term toxicity, rats were treated orally with 80 mg/kg artemether once every 2 weeks for 5 months. After the final treatment, routine blood test results were normal except for reversible reductions of reticulocyte counts and reversible increases in hemoglobin levels. Liver and kidney function and histopathological examination showed no differences between treated and untreated rats. Administration of 400 mg/kg artemether resulted in transient focal vesicle degeneration of the liver or slight damage to the proprius layer lamina of intestinal villi. No damage to the central nervous system tissues, including cerebrum, cerebellum, midbrain, thalamus, pons, medulla oblongata, and spinal cord, was seen at either concentration. There were no alterations in electrocardiograms during the 6-month treatment period. We conclude that 80 mg/kg artemether administered once every 2 weeks is safe, and doses of 400 mg/kg do not result in evidence of neurotoxicology.
AuthorsShuhua Xiao, Yuanqing Yang, Qiqing You, Jürg Utzinger, Huifang Guo, Jiao Peiying, Jinying Mei, Jian Guo, Robert Bergquist, Marcel Tanner
JournalThe American journal of tropical medicine and hygiene (Am J Trop Med Hyg) Vol. 66 Issue 1 Pg. 30-4 (Jan 2002) ISSN: 0002-9637 [Print] United States
PMID12135264 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Antimalarials
  • Artemisinins
  • Hemoglobins
  • Sesquiterpenes
  • Artemether
Topics
  • Administration, Oral
  • Animals
  • Antimalarials (administration & dosage, toxicity)
  • Artemether
  • Artemisinins
  • Blood Cell Count
  • Electrocardiography
  • Female
  • Hematocrit
  • Hemoglobins (metabolism)
  • Histocytochemistry
  • Kidney Function Tests
  • Liver Function Tests
  • Longitudinal Studies
  • Male
  • Rats
  • Rats, Sprague-Dawley
  • Sesquiterpenes (administration & dosage, toxicity)

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