Abacavir Does Not Raise MI Risk, FDA Analysis Shows

March 01, 2011

March 1, 2011 — A review of 26 clinical trials shows that the antiretroviral medication abacavir does not increase the risk for myocardial infarction (MI), despite nagging doubts to the contrary, the US Food and Drug Administration (FDA) announced today.

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 (Ziagen, Epzicom, Trizivir, GlaxoSmithKline). The FDA notes that several observational studies and 1 randomized controlled trial (RCT) report a link between abacavir and a higher risk of MI, whereas other studies do not.

To put the matter to rest, the agency analyzed 26 RCTs from 1996 to 2010 — 16 from the drug manufacturer database, 5 from the AIDS Clinical Trials Group, and 5 from academic medical centers. All of the RCTs involved adults in sample sizes of more than 50; none were pharmacokinetic trials or were conducted in Africa.

The FDA looked for MI outcomes in 9868 participants. Roughly half received an antiretroviral regimen containing abacavir; the other half received a regimen that lacked the agent. The rates of MI in the 2 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 Web site.

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 at https://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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