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Sodium stibogluconate cardiotoxicity and safety of generics

Rijal, S. ; Chappuis, F. ; Singh, R. ; Boelaert, M. ; Loutan, L. ; Koirala, S.

In: Transactions of The Royal Society of Tropical Medicine and Hygiene, 2003, vol. 97, no. 5, p. 597-598

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    Titel
    • Sodium stibogluconate cardiotoxicity and safety of generics
    Autor
    • Rijal, S.. B. P. Koirala Institute of Health Sciences, Dharan, Nepal
    • Chappuis, F.. Travel and Migration Medicine Unit, Geneva University Hospital, 1211 Geneva 14, Switzerland
    • Singh, R.. B. P. Koirala Institute of Health Sciences, Dharan, Nepal
    • Boelaert, M.. Department of Public Health, Prince Leopold Institute of Tropical Medicine, Antwerp, Belgium
    • Loutan, L.. Travel and Migration Medicine Unit, Geneva University Hospital, 1211 Geneva 14, Switzerland
    • Koirala, S.. B. P. Koirala Institute of Health Sciences, Dharan, Nepal
    Dokumententyp
    • Postprint
    Sprache
    • Englisch
    Veröffentlicht in
    • Transactions of The Royal Society of Tropical Medicine and Hygiene, 2003, vol. 97, no. 5, p. 597-598. Royal Society of Tropical Medicine and Hygiene
    Andere elektronische Ausgabe
    OAI-PMH-ID
    • oai:doc.rero.ch:294097
    Summary
    Between April 9 and May 5 2000, an outbreak of fatal cardiotoxicity occurred in Nepal amongst visceralleishmaniasis patients treated with a recently introduced batch of generic sodium stibogluconate (SSG) from GL Pharmaceuticals, Calcutta, India. Eight (36%) of 23 patients treated with this batch died, and in 5 (23%) death was attributed to the cardiotoxicity of the drug. This contrasts with the low total death rate (3.2%) and death rate due to cardiotoxicity (0.8%) observed among 252 patients treated between August 1999 and December 2001 with generic SSG from Albert David Ltd, Calcutta, India. These data show that every batch of generic SSG should be subject to rigorous quality control prior to use