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Title: Potential Risk of Cardiac Events in Patients Treated With Abacavir-Containing Products

"Potential Risk of Cardiac Events in Patients Treated With Abacavir-Containing Products"

OTTAWA, Ontario -- June 25, 2008 -- New safety information regarding a potential increased risk of myocardial infarction in HIV-infected patients treated with abacavir-containing medicinal products (Ziagen, Kivexa, and Trizivir) has been released by Health Canada. These recent findings were published in [The Lancet. The new safety information is based on an ongoing prospective observational study, The Data Collection of Adverse Effects of Anti-HIV Drugs (D:A:D) study that was designed to quantify the incidence of myocardial infarction in HIV-infected patients receiving combination antiretroviral therapy. The D:A:D study, initiated in 1999, includes to date more than 33,000 HIV patients within 11 cohorts in Europe, United States, and Australia. Analyses of data collected up to February 1, 2007, suggest that there is a potential increased risk of myocardial infarction in HIV-infected patients treated with abacavir-containing medicinal products. This elevated risk does not appear to increase further over time, and no excess risk was present in patients who had stopped taking abacavir more than 6 months previously.

Health Canada has undertaken the review of these safety data and will advise Canadians if further risk measures are deemed necessary.

SOURCE: Health Canada

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