FDA: Heart Attack Risk In Two AIDS Drugs

This must be safety day at the FDA. Yet another alert, and this one is about recent findings from analyses of data collected from a study known as D:A:D, or “The Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Study.” This is a large observational study of 33,347 HIV-1 infected patients living in North America, Europe and Australia, who are being followed to evaluate short- and long-term adverse effects of HIV drugs.

Data examined through Feb. 1, 2007, showed that the recent use of Glaxo’s Ziagen and Bristol-Myers Squibb’s Videx were associated with an increased risk of heart attack. Patients taking either med had a greater chance of developing a heart attack than those taking other drugs. The risk didn’t appear to increase over time, but remained stable and appeared to be reversible after the meds were stopped, according to the FDA. These drugs, by the way, are nucleoside reverse transcriptase inhibitors, or NRTIs. The analysis looked at relative risk among cumulative use, current use and past use.

Last last year, both Bristol-Myers and Glaxo received the preliminary findings from the D:A:D Study and searched their clinical study databases, and reported that the results are inconclusive, but didn’t show an increased risk. Here are the key findings from the D:A:D Study…

The excess risk of heart attack in patients taking at least some NRTIs appears to be greater in patients with other risk factors for heart disease, such as a history of heart disease, high cholesterol, high blood pressure, diabetes, smoking, and age. Certain analyses found the risk of heart attack increased by 49 percent in patients taking Videx and increased by 90% in patients taking Ziagen. The increased risk for heart attack remained stable over the course of treatment and the effect was not seen 6 months after stopping the drugs.

The FDA believes the analysis is incomplete; no analyses were conducted evaluating the risk of heart attack when patients take Viread and Emtriva, which are made Gilead Sciences, two other NRTIs. However, the agency is continuing to evaluate the risks and may revise labeling.