The nuclear stress agent Adenoscan (adenosine) has recently been linked to heart attacks, death, and other adverse health consequences. On November 20, 2013, the U.S. Food & Drug Administration (FDA) announced changes to Adenoscan warning labels reflecting these potential side effects, and updated recommendations for use of the medication. Adenoscan is used during cardiac nuclear stress tests to help identify coronary artery disease.
What is Adenoscan?
Adenoscan (generic: adenosine) is a cardiac nuclear stress agent used during cardiac stress tests in patients who cannot exercise adequately. Adenoscan is designed to identify coronary artery disease (CAD) by dilating the arteries of the heart and increasing blood flow to help identify blocks or obstructions in the heart’s arteries, the FDA said. Adenoscan is manufactured by Astellas Pharma US, and was cleared for sale on the U.S. market in 2005.
FDA Warning on Adenoscan
On November 20, 2013, the FDA issued a warning to healthcare professionals about the risk of administering Adenoscan and Lexiscan (regadenoson), another cardiac nuclear stress test agent made by Astellas. A review of the FDA database found at least six heart attacks and 27 deaths reported in Adenoscan users between May 1995 and April 2013. The vast majority of these events occurred within six hours of administering Adenoscan. In some patients, deaths occurred when Adenoscan was administered in conjunction with exercise, which is not recommended or approved by the FDA.
As a result of these problems, the FDA required Astellas to update the Adenoscan prescribing information to include 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.”
Adenoscan Side Effects
In addition to being linked to severe cardiovascular side effects, Adenoscan has also been associated with:
- arm, back, or jaw pain
- chest pain or discomfort
- difficult or labored breathing
- fast or irregular heartbeat
- shortness of breath
- tightness in the chest
Adenoscan overdose symptoms may include:
- feeling of warmth
- increased heart rate
- redness of the face, neck, arms, and occasionally, upper chest