Feature | November 22, 2013

Lexiscan, Adenoscan May Put Patients at Risk for Heart Attack, Death

radiopharmaceuticals and tracers nuclear molecular imaging FDA lexiscan
November 22, 2013 — The U.S. Food and Drug Administration (FDA) is warning healthcare 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). The FDA has approved changes to the drug labels to reflect these serious events and updated recommendations for use of these agents. At this time, data limitations prevent FDA from determining if there is a difference in risk of heart attack or death between Lexiscan and Adenoscan.
 
The Warnings and 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 literature prompted approval changes to the drug labels to include updated recommendations for use.
 
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 (CAD). 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.?
 
Doctors should screen all nuclear stress test candidates for their suitability to receive Lexiscan or Adenoscan, as well as 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. Cardiac resuscitation equipment and trained staff should be available before administering Lexiscan or Adenoscan.
 
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
 
For more information: www.fda.gov

Related Content

ScImage and Invia Partnership Announced
News | Cardiac PACS| September 19, 2017
ScImage Inc. and Invia Imaging Solutions recently announced formation of a joint partnership at the American Society of...
CZT SPECT camera detectors offered by GE.

A display of CZT SPECT gamma camera detectors at RSNA 2016. These detectors are more sensitive than those used in older cameras, allowing for faster scans or lower radiation dose. 

Feature | Nuclear Imaging| September 19, 2017 | Dave Fornell
Cardiac nuclear myocardial perfusion imaging (MPI) has been a mature area of imaging for years, but has recently star
Philips Launches CardioMD IV Cardiac SPECT Solution at ASNC 2017
Technology | SPECT Imaging| September 15, 2017
September 15, 2017 — Philips highlighted its newest solution for...
ARTMS Products Inc. and GE Healthcare Team Up to Expand Cyclotron-Produced Radioisotopes
News | Radiopharmaceuticals and Tracers| August 30, 2017
ARTMS Products Inc. signed a strategic partnership with GE Healthcare around ARTMS’ proprietary QUANTM99 Irradiation...
Sponsored Content | Videos | Nuclear Imaging| August 24, 2017
Prem Soman, M.D., director of nuclear cardiology at the Heart and Vascular Institute, University of Pittsburgh, and p
Sponsored Content | Videos | Nuclear Imaging| August 24, 2017
Randy Thompson, M.D., attending cardiologist, St.
ASNC and SNMMI Release Joint Document on Diagnosis, Treatment of Cardiac Sarcoidosis
News | Cardiac Imaging| August 18, 2017
August 18, 2017 — The American Society of...
Houston Methodist Hospital Enters Multi-Year Technology and Research Agreement With Siemens Healthineers
News | Cardiac Imaging| August 17, 2017
Houston Methodist Hospital and Siemens Healthineers have entered into a multi-year agreement to bring cutting-edge...
New PET-CT Scan Improves Detection in Rare Cardiac Condition
News | PET-CT| July 25, 2017
Using a new imaging technique that can diagnose cardiac sarcoidosis much more accurately than traditional tests,...
Overlay Init