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US FDA Issues Update of Ongoing HIV Drug Safety Review WASHINGTON, DC -- March 27, 2008 -- The US Food and Drug Administration has been made aware of recent findings from analyses of data collected from The Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) study. The D:A:D study is a large observational study of 33,347 HIV-1-infected patients living in North America, Europe, and Australia. Patients in this study are being followed to evaluate the short- and long-term adverse effects of treatment with anti-HIV drugs. Analyses of data collected through February 1, 2007, examined the risk of myocardial infarction (MI) in patients taking selected HIV drugs from the class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs): zidovudine, stavudine, abacavir, didanosine, and lamivudine. The analyses, specifically, describe the relative risk of MI among cumulative use, recent use of these drugs (currently using or use within the past 6 months), and past use (last use more than 6 months ago). These analyses showed that recent use of abacavir or didanosine was associated with an increased risk of MI. Patients taking either of these drugs had a greater chance of developing a heart attack compared with patients taking other medications. The risk did not appear to increase over time but remained stable and appeared to be reversible after abacavir or didanosine were stopped. In late 2007, GlaxoSmithKline (GSK), the manufacturer of abacavir, received the preliminary findings from the D:A:D study analyses and conducted a search of their own clinical study databases. The results of the GSK analysis are inconclusive but did not show an increased risk. Bristol Myers Squibb (BMS), the manufacturer of didanosine, conducted an analysis of their clinical databases and, similarly, found no increased risk for MI with didanosine use. The results of the BMS analysis are also inconclusive. Key findings from the D:A:D study are as follows: Ÿ The excess risk of MI in patients taking at least some NRTIs appears to be greater in patients with other risk factors for heart disease. Risk factors include a history of MI, hypercholesterolemia, hypertension, diabetes, smoking, and age. Ÿ Certain analyses found the risk of MI increased by 49% in patients taking didanosine and increased by 90% in patients taking abacavir. Ÿ The increased risk for MI remained stable over the course of treatment, and the effect was not seen 6 months after stopping the drugs. The FDA currently believes analyses conducted with D:A:D study data are incomplete; no analyses were conducted evaluating the risk of MI when patients take tenofovir or emtricitabine, 2 other drugs in the class of NRTIs. However, the FDA continues to evaluate the overall risks and benefits of abacavir and didanosine. This evaluation may result in the need to revise labeling for the products. Until this evaluation is complete, healthcare providers should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking, including abacavir and didanosine. The FDA urges healthcare professionals to promptly report serious and unexpected adverse reactions associated with abacavir to the FDA MedWatch reporting program. SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version