FDA Issues Warning on Regadenoson, Adenosine

November 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 at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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