Safety Announcement
[03-01-2011] - The U.S. Food and Drug Administration (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. Available medications that contain
abacavir include Ziagen, Trizivir, and Epzicom.
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. Patients should not stop taking their abacavir without first talking to their
healthcare professional.
Read more... FDA U.S. Food and
Drug Administration
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