WHO Pharmaceuticals Newsletter 2003, No. 03
(2003; 14 pages) Voir le document au format PDF
Table des matières
Fermer ce répertoireREGULATORY MATTERS
Afficher le documentACETYLSALICYLIC ACID - MHRA confirms labelling change
Afficher le documentACITRETIN - Warnings of depression added to label
Afficher le documentASTEMIZOLE - Withdrawn due to life-threatening ventricular arrhythmias
Afficher le documentCAMELIA SINENSIS - Ethanolic extract products withdrawn due to hepatotoxicity
Afficher le documentDIETARY SUPPLEMENTS - Withdrawal of two products due to presence of sildenafil
Afficher le documentHUA FO - Presence of tadalafil
Afficher le documentIODINE - Some products contain more than the RDA
Afficher le documentLEVODOPA/CARBIDOPA - New warning about somnolence and sudden onset sleep
Afficher le documentLINDANE - Additional warnings and medication guide added to label
Afficher le documentNEFAZODONE - Regulatory status update
Afficher le documentNIMESULIDE - Paediatric preparations banned in Bangladesh
Afficher le documentPERGOLIDE MESYLATE - Risk of cardiac valvulopathy
Afficher le documentREPAGLINIDE - Contraindicated with gemfibrozil
Afficher le documentRISPERIDONE - Prescribing information updated to reflect cardiovascular adverse events
Afficher le documentTELITHROMYCIN - Aggravation of myasthenia gravis
Ouvrir ce répertoire et afficher son contenuSAFETY OF MEDICINES
Ouvrir ce répertoire et afficher son contenuCURRENT CONCERNS
Ouvrir ce répertoire et afficher son contenuDRUGS OF INTEREST
Ouvrir ce répertoire et afficher son contenuFEATURE
 

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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