Drugs

FDA Drug Safety Podcast: FDA warns of rare but serious risk of heart attack and death with cardiac nuclear stress test drugs Lexiscan (regadenoson) and Adenoscan (adenosine)

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Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today’s topic: FDA warns of rare but serious risk of heart attack and death with cardiac nuclear stress test drugs Lexiscan (active ingredient regadenoson) and Adenoscan (active ingredient adenosine).

Lesley Navin, RN, MSN, Consumer Safety Officer in the Division, will provide you with additional information about this communication.

Lesley Navin: On November 20th, 2013 the U.S. Food and Drug Administration (or 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 (active ingredient regadenoson) and Adenoscan (active ingredient 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 (or FAERS) database and the medical literatureprompted 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 prevents the Agency 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.

At this time, FDA recommends health care professionals to be aware of the following:

  • Cases of myocardial infarction and death have occurred following the administration of Lexiscan injection or Adenoscan infusion.
  • Both drugs present a risk to patients, especially to those with ongoing cardiac ischemia. Some cases of myocardial infarction and death have occurred in patients with pre-existing unstable angina or cardiovascular instability.
  • Screen all nuclear stress test candidates for their suitability to receive Lexiscan or Adenoscan.
  • Avoid using these drugs in patients with symptoms or signs of acute myocardial ischemia such as unstable angina or cardiovascular instability; these patients may be at greater risk of serious cardiovascular reactions to Lexiscan or Adenoscan.
  • Cardiac resuscitation equipment and trained staff should be readily available before administering Lexiscan or Adenoscan.
  • Due to limitations in the currently available data, FDA is unable to discern a difference in risk for acute myocardial infarction or death between Lexiscan and Adenoscan.
  • Review the updated Lexiscan and Adenoscan labels for the latest recommendations.
  • Other cardiac nuclear stress test agents include:
    • intravenous dipyridamole (which is FDA-approved for use during cardiac stress test) and
    • dobutamine (which is not FDA-approved for use during cardiac stress test)
  • And report adverse events involving Lexiscan or Adenoscan to the FDA MedWatch program at www.fda.gov/medwatch.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication as well as the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

And follow us on Twitter @FDA_Drug_Info for up to the minute important drug information. Know the moment it happens

 

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Page Last Updated: 12/12/2014
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