FDA Issues Warning on Regadenoson, Adenosine
Reporter: Aviva Lev-Ari, PhD, RN
[11-20-2013] The U.S. Food and Drug Administration (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). We have approved changes to the drug labels to reflect these serious events and updated our recommendations for use of these agents. Health care professionals should avoid using these drugs in patients with signs or symptoms of unstable angina or cardiovascular instability, as these patients may be at greater risk for serious cardiovascular adverse reactions.
Lexiscan and Adenoscan are FDA approved for use during cardiac nuclear stress tests in patients who cannot exercise adequately. Lexiscan and Adenoscan help identify coronary artery disease. They do this by dilating the arteries of the heart and increasing blood flow to help identify blocks or obstructions in the heart’s arteries. Lexiscan and Adenoscan cause blood to flow preferentially to the healthier, unblocked or unobstructed arteries, which can reduce blood flow in the obstructed artery. In some cases, this reduced blood flow can lead to a heart attack, which can be fatal.
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 literature1,2 (see Data Summary) prompted us to approve changes to the drug labels to include updated recommendations for use. Some events occurred in patients with signs or symptoms of acute myocardial ischemia, such as unstable angina or cardiovascular instability. Cardiac resuscitation equipment and trained staff should be available before administering Lexiscan or Adenoscan. At this time, data limitations prevent us from determining if there is a difference in risk of heart attack or death between Lexiscan and Adenoscan.
We recommend that health care professionals and their patients discuss any questions or concerns.
DisclosuresNovember 20, 2013
Clinicians should avoid using the imaging agents regadenoson (Lexiscan, Astellas Pharma US) and adenosine (Adenoscan, Astellas Pharma US) for cardiac nuclear stress tests of patients with signs or symptoms of unstable angina or cardiovascular instability because the drugs may increase their risk for a fatal heart attack, the US Food and Drug Administration (FDA) announced today.
The recommendation will appear on updated labels for both drugs.
The agency approved adenosine in 1995 and regadenoson in 2008 for radionuclide myocardial perfusion imaging in patients who cannot undergo exercise stress testing. Both agents dilate coronary arteries and increase blood flow to help spot blockages.
The FDA placed regadenoson on its quarterly list of drugs to monitor in September after it received reports possibly linking the drug to myocardial infarctions (MI) and death during the second quarter of 2013 through its FDA Adverse Event Reporting System (FAERS) database. The labels for both regadenoson and adenosine had previously warned of the risk for MI.
An FDA review of the FAERS database found 26 MI cases and 29 deaths that occurred after the administration of regadenoson since its approval. Six MI cases and 27 deaths turned up for adenosine following that drug’s debut.
The most common adverse events associated in fatal cases of regadenoson use included cardiac arrest, MI, loss of consciousness, and respiratory arrest. For adenosine, common adverse events linked to death were cardiorespiratory arrest, dyspnea, cardiac arrest, respiratory arrest, and ventricular tachycardia.
“At this time, data limitations prevent us from determining if there is a difference in risk of heart attack or death between Lexiscan and Adenoscan,” the FDA stated in a news release.
The agency advised clinicians to do the following:
- Screen all candidates for nuclear stress tests to determine their cardiovascular fitness for the 2 drugs.
- Ensure that cardiac resuscitation equipment and trained staff are available before administering adenosine or regadenoson.
- Consider 2 other nuclear stress test agents — intravenous dipyridamole, which is FDA-approved for this use, and dobutamine, which is not FDA-approved.
More information on today’s announcement is available on the FDA Web site.
To report problems with regadenoson or adenosine, contact MedWatch, the FDA’s safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online athttps://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.