October 21, 2013
As you may know, the U.S. Food and Drug Administration (FDA) has placed regadenoson—a commonly used cardiac imaging agent—on its quarterly list of drugs to monitor. Regadenoson is a coronary vasodilator that produces maximal hyperemia quickly and maintains it for an optimal duration that is practical for radionuclide myocardial perfusion imaging. The drug was placed on this list due to potential signs of myocardial infarction and death.
Placing it on the watch list does not mean that FDA has concluded that the drug has the listed risk. According to the FDA, “The listing of a drug and a potential safety issue on [our] Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication.”
The Society of Nuclear Medicine and Molecular Imaging is monitoring the situation and will advise members when there is further information. For additional details, click here.