Sodium stibogluconate cardiotoxicity and safety of generics

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 di...

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Bibliographic Details
Published in:Transactions of the Royal Society of Tropical Medicine and Hygiene 2003-09, Vol.97 (5), p.597-598
Main Authors: Rijal, S., Chappuis, F., Singh, R., Boelaert, M., Loutan, L., Koirala, S.
Format: Article
Language:English
Subjects:
Antimony Sodium Gluconate - adverse effects
Antiprotozoal Agents - adverse effects
Biological and medical sciences
cardiotoxicity
chemotherapy
Drugs, Generic - adverse effects
General aspects
generic drugs
Heart Diseases - chemically induced
Human infectious diseases. Experimental studies and models
Humans
Infectious diseases
Leishmaniasis, Visceral - drug therapy
Medical sciences
Nepal
Risk Factors
sodium stibogluconate
visceral leishmaniasis
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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.
ISSN:0035-9203
1878-3503
DOI:10.1016/S0035-9203(03)80043-3