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FDA Issues Safety Alert on Risks Tied to Cardiac Stress-testing Agents

Filed November 21st, 2013 Laurie

The U.S. Food and Drug Administration (FDA) issued a safety warning yesterday about a rare but serious risk of heart attack and death caused by use of the cardiac nuclear stress test agents Lexiscan (regadenoson) and Adenoscan (adenosine).

The agency approved changes to the drug labels to highlight these serious events and updated recommendations for use of these agents. According to the warning, data limitations have prevented the FDA from determining if there is a difference in the risk of heart attack or death between Lexiscan and Adenoscan.

Lexiscan and Adenoscan are approved by the FDA for use during cardiac nuclear stress tests in patients who are unable to adequately exercise to help identify coronary artery disease. The agents dilate the arteries of the heart and increase blood flow preferentially to the healthier, unblocked, or unobstructed arteries, which can reduce blood flow in the obstructed artery, sometimes resulting in a heart attack.

Changes to the drug labels were approved by the FDA amid recent reports of serious adverse events in the FDA Adverse Event Reporting System (FAERS) database, including 26 cases of heart attack and 29 deaths that occurred after the administration of Lexiscan, and six cases of heart attack and 27 deaths that occurred after the administration of Adenoscan, reported.

The FDA recommends that all nuclear stress test candidates be screened for signs and symptoms of unstable angina or cardiovascular instability, as these patients may be at greater risk for serious cardiovascular adverse reactions. Cardiac resuscitation equipment and trained staff should be present before Lexiscan or Adenoscan is administered. The agency recommends the use of two other agents – intravenous dipyridamole, which is FDA-approved for this use, and dobutamine, which is not FDA-approved – for patients who cannot tolerate Lexiscan or Adenoscan, according to

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