WHO Pharmaceuticals Newsletter 2003, No. 04
(2003; 13 pages) View the PDF document
Table of Contents
Close this folderREGULATORY MATTERS
View the documentABACAVIR, LAMIVUDINE, TENOFOVIR - Virologic non-response in HIV with combination therapy
View the documentACETYL-SALICYLIC ACID (PAEDIATRIC) - OTC withdrawal
View the documentACETYL-SALICYLIC ACID, PARACETAMOL, IRON - New packaging standards for improving child resistance
View the documentBENZ-BROMARONE - Withdrawn due to reports of liver damage
View the documentEZETIMIBE - Labelling update regarding hypersensitivity reactions
View the documentLEFLUNOMIDE - Explicit liver function monitoring directions added to label
View the documentPAROXETINE - Unfavourable risk benefit ratio in children and adolescents
View the documentSALMETEROL - Risk of life-threatening asthma episodes
View the documentSOMATROPIN (rDNA ORIGIN) - Reports of fatalities in paediatric patients with Prader-Willi syndrome
View the documentTIROFIBAN - Advice against off-label use
View the documentTOPIRAMATE - Risk of oligohidrosis and hyperthermia
Open this folder and view contentsSAFETY OF MEDICINES
Open this folder and view contentsDRUGS IN THE NEWS
 

BENZ-BROMARONE - Withdrawn due to reports of liver damage

France. Sanofi-Synthélabo has withdrawn its hyperuricaemic product benzbromarone (Desuric) in France following reports of serious liver damage associated with the product's use. Benzbromarone (Desuric) has been marketed in France since 1976, but rare reports of serious cytolytic liver damage, including fatal cases and others requiring liver transplants, have led to an unfavourable benefit/risk ratio. The company has therefore decided to stop the marketing of this product in France and to recall all stocks.

Reference:

Chaibriant H. Stop marketing of proprietary medical product DESURIC (Rm) (benzbromarone), 22 Apr 2003. Available from URL: http://agmed.sante.gouv.fr

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Last updated: May 3, 2013