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| |  Increased Risk of Myocardial Infarction With Fosamprenavir OTTAWA, Ontario -- July 23, 2009 -- GlaxoSmithKline (GSK), in consultation with Health Canada, is informing healthcare professional of important safety information regarding a potential association between myocardial infarction and exposure to fosamprenavir (Telzir) in patients with HIV. A nested case-control study conducted in the French Hospital Database on HIV has reported an association between exposure to fosamprenavir and an increased risk of myocardial infarction (odds Ratio [OR] 1.55 per additional year of exposure; 95% confidence interval [CI], 1.20-1.99). This may be related to the propensity for this drug class to raise blood lipids. Triglyceride and cholesterol levels should therefore be checked prior to initiating therapy with fosamprenavir and at periodic intervals during therapy. Appropriate clinical management of lipid disorders should be initiated as required. Other modifiable risk factors for cardiovascular disease such as hypertension, diabetes, and smoking should also be monitored in patients with HIV and managed as clinically appropriate. Recent data presented at the 16th Conference on Retroviruses and Opportunistic Infections (CROI 2009) suggested a potential association between fosamprenavir and myocardial infarction in HIV-positive adults. The nested case-control study reported an increased risk of myocardial infarction in association with cumulative exposure to fosamprenavir (OR, 1.55 per additional year of exposure; 95% CI, 1.20-1.99). Myocardial infarction has already been identified as being potentially associated with the protease inhibitor (PI) class in the ongoing Data Collection on Adverse Events of Anti-HIV Drugs (DAD) study. Suppression of viral replication in HIV disease with antiretroviral therapy is of the utmost importance. Physicians should monitor a patient's cardiovascular risk as part of the follow-up and seek to adjust modifiable risk factors. Combination antiretroviral therapy is associated with redistribution lipodystrophy in HIV-positive patients. Clinical examination should include evaluation for physical signs of fat distribution. HIV infection itself has been associated with lipid disorders and ischaemic heart disease. GSK will be working with Health Canada on this issue to integrate new safety information in the Canadian Product Monograph. Managing marketed health product-related adverse reactions depends on healthcare professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of myocardial infarction or other serious or unexpected adverse reactions in patients receiving fosamprenavir tablets and oral solution should be reported to GSK or Health Canada at the following addresses: GlaxoSmithKline Inc. Canada Vigilance Program SOURCE: Health Canada
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