FDA Studies Still Investigating Abacavir for Heart Attack Potential

March 28, 2011 – The antiviral medication Abacavir is the focus of a current Food and Drug Administration (FDA) study reviewing its potential to increase the risk of heart attack in some patients.  The FDA is continuing its evaluation of Abacavir and its other related drugs, Ziagen, Trizivir, and Epzicom. These drugs have been used for the treatment of HIV-1 infection and currently have FDA warnings regarding increased hypersensitivity reactions.  New observational studies and a randomized controlled trial have shown evidence of an increased risk of heart attack in patients prescribed Abacavir. A meta-analysis of 26 randomized clinical trials evaluating the drug did not show an increased risk of heart attack, but further evaluations are being conducted.  Until a confirmed warning has been issued by the FDA linking heart attack susceptibility to Abacavir use, patients are encouraged to continue their normal use of the drugs as prescribed by their doctors. Healthcare officials are also not to be discouraged from prescribing Abacavir as directed by the professional label.  As the FDA continues to evaluate Abacavir they ask that patients on the drug and doctors that prescribe it to keep watch on adverse events, side effects and problems related to their use. In doing so, the FDA can continue to provide adequate regulation and control of potentially dangerous drugs.  Whenever you begin taking a new medication you should keep your doctor informed of any side effects or changes you notice. This information not only helps prevent the risk of serious damages or fatal events due to drug complications, but can also help the FDA detect potentially dangerous drugs and remove them from common use.

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