FDA Issues Warning for Cardiac Nuclear Stress Test Agents

The FDA warned health care professionals of a “rare but serious risk of heart attack and death” associated with use of regadenoson (Lexiscan) and adenosine (Adenoscan). The drugs’ labels are being updated to reflect the risk and revised recommendations for use. According to the warning, these drugs should not be used in patients who show signs of unstable angina or cardiovascular instability since they could be at an increased risk for serious cardiovascular adverse reactions. "[D]ata limitations prevent FDA from determining if there is a difference in risk of heart attack or death between Lexiscan and Adenoscan,” the FDA clarified. Read the full FDA Alert.

Keywords: Adenosine, Angina, Unstable, Drug Labeling, Exercise Test, Purines, Pyrazoles

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