(2003; 14 pages)
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
‘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