WHO Pharmaceuticals Newsletter 2003, No. 03
(2003; 14 pages) Ver el documento en el formato PDF
Índice de contenido
Cerrar esta carpetaREGULATORY MATTERS
Ver el documentoACETYLSALICYLIC ACID - MHRA confirms labelling change
Ver el documentoACITRETIN - Warnings of depression added to label
Ver el documentoASTEMIZOLE - Withdrawn due to life-threatening ventricular arrhythmias
Ver el documentoCAMELIA SINENSIS - Ethanolic extract products withdrawn due to hepatotoxicity
Ver el documentoDIETARY SUPPLEMENTS - Withdrawal of two products due to presence of sildenafil
Ver el documentoHUA FO - Presence of tadalafil
Ver el documentoIODINE - Some products contain more than the RDA
Ver el documentoLEVODOPA/CARBIDOPA - New warning about somnolence and sudden onset sleep
Ver el documentoLINDANE - Additional warnings and medication guide added to label
Ver el documentoNEFAZODONE - Regulatory status update
Ver el documentoNIMESULIDE - Paediatric preparations banned in Bangladesh
Ver el documentoPERGOLIDE MESYLATE - Risk of cardiac valvulopathy
Ver el documentoREPAGLINIDE - Contraindicated with gemfibrozil
Ver el documentoRISPERIDONE - Prescribing information updated to reflect cardiovascular adverse events
Ver el documentoTELITHROMYCIN - Aggravation of myasthenia gravis
Abrir esta carpeta y ver su contenidoSAFETY OF MEDICINES
Abrir esta carpeta y ver su contenidoCURRENT CONCERNS
Abrir esta carpeta y ver su contenidoDRUGS OF INTEREST
Abrir esta carpeta y ver su contenidoFEATURE
 

PERGOLIDE MESYLATE - Risk of cardiac valvulopathy

Canada. A ‘Dear Healthcare Professional’ letter regarding pergolide mesylate (Permax) and the risk of cardiac valvulopathy has been issued by Eli Lilly Canada Inc and Draxis Health Inc. During post-marketing surveillance, a small number of individuals have been identified as developing cardiac valvulopathy involving one or more valves during pergolide therapy. In some cases, symptoms of valvulopathy resolved on discontinuation of pergolide therapy; two patients required valve replacement. Although a causal relationship has not been established, the ‘Warnings’ section of the product monograph is to be updated accordingly. The company has sent out a similar letter to healthcare professionals in the USA earlier in the year, in February 2003 (WHO Pharmaceuticals Newsletter No.2, 2003).

Reports in WHO-file: Cardiomyopathy 4

Reference:
‘Dear Healthcare Professional’ letter from Draxis Health Inc and Eli Lilly Canada Inc, 14 Apr 2003. Available from URL: http://www.hc-sc.gc.ca

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