Abacavir does not raise MI risk: FDA

March 01, 2011

Silver Spring, MD - A review of 26 clinical trials shows that the antiretroviral medication abacavir (Ziagen, GlaxoSmithKline) does not increase the risk for MI, despite nagging doubts to the contrary, the US Food and Drug Administration (FDA) announced today [1].

The meta-analysis attempted to resolve conflicting information on the safety of the antiretroviral medication, used in combination with other antiretroviral drugs for the treatment of HIV-1 infection. (The FDA notes that several observational studies and one randomized trial report a link between abacavir and a higher risk of MI, while other studies do not.)

To put the matter to rest, the agency analyzed 26 randomized clinical trials from 1996 to 2010—16 from the drug manufacturer database, five from the A IDS Clin ical Trials Group, and five from academic medical centers. All of the trials involved adults in sample sizes of more than 50; none were pharmacokinetic trials or conducted in Africa.

The FDA looked for MI outcomes in 9868 subjects. Roughly half received an antiretroviral regimen containing abacavir; the other half received a regimen that lacked the agent. The rates of MI in the two groups were roughly equal.

"No statistically significant association between MI and abacavir-containing regimen was detected," the agency said.

The agency is advising clinicians to continue prescribing abacavir according to the professional label.

More information about today's announcement is available on the FDA website.

To report adverse events related to abacavir, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

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