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Posted 22 Nov 2013 by Drugs.com
THURSDAY, Nov. 21, 2013 – Doctors are being warned that two drugs used in cardiac nuclear stress tests can cause heart attacks and death in patients, the U.S. Food and Drug Administration says. These rare but serious events have led the agency to approve changes to the labels of Lexiscan (regadenoson) and Adenoscan (adenosine) and to update recommendations for their use. Cardiac nuclear stress tests can diagnose heart problems that other stress tests or an examination at rest might not detect. The drugs are approved for use during cardiac nuclear stress tests in patients who cannot exercise. The drugs dilate the arteries of the heart and increase blood flow to help reveal blockages or obstructions in the heart's arteries, the FDA explained. Lexiscan and Adenoscan cause blood to flow to the healthier, unobstructed arteries, which can reduce blood flow in an obstructed artery. But in ... Read more
FDA Medwatch Alert: Lexiscan (regadenoson) and Adenoscan (adenosine): Drug Safety Communication - Rare but Serious Risk of Heart Attack and Death
Posted 20 Nov 2013 by Drugs.com
[Posted 11/20/2013] ISSUE: The FDA is warning health care professionals of the rare but serious risk of heart attack and death with use of the cardiac nuclear stress test agents Lexiscan (regadenoson) and Adenoscan (adenosine). FDA has approved changes to the drug labels to reflect these serious events and updated recommendations for use of these agents. At this time, data limitations prevent FDA from determining if there is a difference in risk of heart attack or death between Lexiscan and Adenoscan. The Warnings & Precautions section of the Lexiscan and Adenoscan labels previously contained information about the possible risk of heart attack and death with use of these drugs. However, recent reports of serious adverse events in the FDA Adverse Event Reporting System (FAERS) database and the medical literature prompted approval changes to the drug labels to include updated ... Read more