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The U.S. Food and Drug Administration (FDA) is warning that Adenoscan (adenosine), an intravenous medication used during cardiac stress tests, is associated with a risk of heart attacks and death. From 1995 – 2013, the FDA received 6 reports of heart attack and 27 deaths.

What is Adenoscan?

Adenoscan (adenosine) is an injection drug that is administered during cardiac stress tests. Hospitals use these tests to diagnose coronary artery disease. Normally, an image is taken of the heart at rest, and another image is taken while the patient is on a treadmill or exercise bike. For patients who cannot exercise due to a medical condition, Adenoscan simulates exercise by dilating arteries and stressing the heart.

Adenoscan and Cardiac Stress Tests

During a cardiac stress test, Adenoscan causes coronary arteries (blood vessels that supply oxygenated blood to the heart muscle) to increase blood-flow. When Adenoscan is administered to a patient with narrow or obstructed coronary arteries, blood may stop flowing through these arteries and only flow through healthy arteries. This can cut off blood-flow to part of the heart muscle, resulting in a deadly heart attack.

FDA Safety Warning for Adenoscan

November 20, 2013 — The U.S. Food and Drug Administration (FDA) is warning healthcare professionals about the risk of administering Adenoscan and Lexiscan. A review of the FDA database identified 6 heart attacks and 27 deaths between May 18, 1995 and April 10, 2013, usually within 6 hours of administering Adenoscan. In some cases, deaths occurred when Adenoscan was administered concurrently with exercise, which is not approved by the FDA.

Updated Prescribing Information for Adenoscan

The FDA required Astellas, the drug-maker behing Adenoscan, to update the Prescribing Information with stronger warnings about the risk of heart attack and death:

“Fatal and nonfatal cardiac arrest, sustained ventricular tachycardia (requiring resuscitation), and myocardial infarction have occurred following Adenoscan infusion. Avoid use in patients with symptoms or signs of acute myocardial ischemia, for example, unstable angina or cardiovascular instability; these patients may be at greater risk of serious cardiovascular reactions to Adenoscan. Appropriate resuscitative measures should be available.”

Cardiovascular Side Effects of Adenoscan

  • Breathing problems
  • Irregular heart rhythm (pounding heartbeat)
  • Chest pain
  • Low blood pressure
  • Decreased flow of oxygenated blood to heart
  • Heart attack (myocardial infarction)
  • Death

 

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