Canada. Shire BioChem Inc, following discussions with Health Canada, has issued a 'Dear Health-care Professional' letter and a Public Advisory concerning new safety information on pergolide (Permax) and the risk of cardiac valvulopathy. The letter highlights two recent studies that have shown an increased frequency of cardiac valvulopathy associated with pergolide (Permax), compared with non-ergot dopamine agonists. Given the potentially serious nature of these events, the Warnings, Dosage and Administration, Adverse Events, Post-Marketing and Consumer Information sections of the pergolide (Permax) product monograph are to be revised. The new labelling information notes that pergolide (Permax) is not recommended in patients with a history of serious inflammation, fibrosis or cardiac valvulopathy, and physicians are advised to reassess the risks and benefits of pergolide (Permax) compared with nonergot dopamine agonists. Physicians are also advised to inform patients of the risk of cardiac valvulopathy and other serious fibrotic reactions. Additionally, pretreatment cardiovascular evaluation and periodic monitoring for the development of valvular disease or fibrosis are recommended.
'Dear Health-care Professional' letter from Shire Biochem Inc, 12 October 2004. Available on the Internet at www.hc-sc.gc.ca