FDA Drug Safety Communication

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FDA Date: 2/28/11

FDA Drug Safety Communication for Abacavir

Safety Review Update of Abacavir and Possible Increased Risk of Heart Attack

FDA is updating the public about its ongoing safety review of abacavir and a possible increased risk of heart attack. Abacavir is an antiviral medication used in combination with other antiretroviral drugs for the treatment of HIV-1 infection.

There has been conflicting information on the potential increased risk of heart attack with abacavir treatment. An increased risk of heart attack (myocardial infarction, or MI) has been seen in several observational studies and one randomized controlled trial (RCT) with abacavir. However, an increased risk of heart attack has not been seen in other RCTs and the safety database maintained by the drug manufacturer.

FDA conducted a meta-analysis of 26 randomized clinical trials that evaluated abacavir. This meta-analysis did not show an increased risk of MI associated with the use of abacavir. Healthcare professionals should continue to prescribe abacavir according to the professional label.

FDA will continue to communicate any new safety information to the public as it becomes available.

View the full FDA Drug Safety Communication on FDA.gov