Sodium stibogluconate cardiotoxicity and safety of generics

Abstract

Between April 9 and May 5 2000, an outbreak of fatal cardiotoxicity occurred in Nepal amongst visceral leishmaniasis 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.