FDA Issues Drug Safety Communication Over Serious Health Risks Tied to Cardiac Nuclear Stress Test Agents

cardiac-nuclear-stress-test-health-risksThe risk of rare, but serious, heart attack and death have been tied to Lexiscan (regadenoson) and Adenoscan (adenosine), according to a U.S. Food and Drug Administration (FDA) Drug Safety Communication. The drugs are cardiac nuclear stress test agents.

The agency approved changes to the drugs’ labels to reflect these serious events and also updated recommendations for use of these agents. At this time, data limitations prevent the agency from determining if a difference exists in heart attack and death risks between Lexiscan and Adenoscan, it indicated.

The “Warnings & Precautions” section of the cardiac nuclear stress test agents’ labels previously contained information concerning the potential heart attack and death risk tied to use of Lexiscan and Adenoscan. Recent reports of serious adverse events in the FDA Adverse Event Reporting System (FAERS) database and the medical literature prompted approval changes to the two drugs’ labels to include updated usage recommendations.

Both Lexiscan and Adenoscan are approved by the FDA for use during cardiac nuclear stress tests in those patients who are unable to adequately exercise. Both drugs help identify coronary artery disease 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 cause a heart attack. This can be fatal.

The recommendations include screening all nuclear stress test candidates for their suitability to receive Lexiscan or Adenoscan. Also, these drugs should not be used in patients who have signs or symptoms of unstable angina or cardiovascular instability—these patients may be at increased risk for serious cardiovascular adverse reactions.

Cardiac resuscitation equipment and trained staff should always be available before the administration of Lexiscan or Adenoscan.

Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of either Lexiscan or Adenoscan to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by completing and submitting the report online at www.fda.gov/MedWatch/report.htm; downloading the form at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm; or calling, toll-free at 1.800.332.1088, to request a reporting form. The form should be completed and returned to the address on the pre-addressed form or submitted, by fax, to 1.800.FDA-0178.

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