WHO Pharmaceuticals Newsletter 2003, No. 04
(2003; 13 pages) Voir le document au format PDF
Table des matières
Fermer ce répertoireREGULATORY MATTERS
Afficher le documentABACAVIR, LAMIVUDINE, TENOFOVIR - Virologic non-response in HIV with combination therapy
Afficher le documentACETYL-SALICYLIC ACID (PAEDIATRIC) - OTC withdrawal
Afficher le documentACETYL-SALICYLIC ACID, PARACETAMOL, IRON - New packaging standards for improving child resistance
Afficher le documentBENZ-BROMARONE - Withdrawn due to reports of liver damage
Afficher le documentEZETIMIBE - Labelling update regarding hypersensitivity reactions
Afficher le documentLEFLUNOMIDE - Explicit liver function monitoring directions added to label
Afficher le documentPAROXETINE - Unfavourable risk benefit ratio in children and adolescents
Afficher le documentSALMETEROL - Risk of life-threatening asthma episodes
Afficher le documentSOMATROPIN (rDNA ORIGIN) - Reports of fatalities in paediatric patients with Prader-Willi syndrome
Afficher le documentTIROFIBAN - Advice against off-label use
Afficher le documentTOPIRAMATE - Risk of oligohidrosis and hyperthermia
Ouvrir ce répertoire et afficher son contenuSAFETY OF MEDICINES
Ouvrir ce répertoire et afficher son contenuDRUGS 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BENZ-BROMARONE - Withdrawn due to reports of liver damage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 Sanofi-Synthélabo has withdrawn its hyperuricaemic product benzbromarone (Desuric) in France following reports of serious liver damage associated with the product's use.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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Dernière mise à jour: le 3 mai 2013