Japan - The Ministry of Health, Labour and Welfare (MHLW) has called for hepatic dysfunction, jaundice and rhabdomyolysis to be included in the ‘Clinically significant adverse reactions’ section of clarithromycin-containing products Clarith® and Klaricid® for paediatric use. Previously, various liver disorders were included in the ‘Other adverse reactions’ section, while rhabdomyolysis was included in the ‘Drug interactions’ section as an interaction with HMG-CoA reductase inhibitors. This labelling change has been made in response to 23 reported cases of hepatic dysfunction and 6 of rhabdomyolysis received since 1996 and associated with clarithromycin use.
Reference: MHLW Pharmaceuticals and Medical Devices Safety Information. ADR updates from Japan. Media Release, March 2001.