Cardio Imaging Agent Placed on FDA Watch List


October 15, 2013

The US Food and Drug Administration (FDA) has placed regadenoson (Lexiscan, Astellas Pharma US), a cardiovascular imaging agent, on its latest quarterly list of products to monitor because of potential signals of myocardial infarction (MI) and death, the agency announced last month.

Regadenoson, a selective adenosine-receptor agonist, produces vasodilation in coronary arteries. It is indicated for radionuclide myocardial perfusion imaging in patients who can't undergo exercise stress testing. Clinicians also use it for CT imaging on an off-label basis.

The FDA received reports possibly linking regadenoson to MI and death during the second quarter of 2013 through its FDA Adverse Event Reporting System (FAERS) database. Ever since the drug received FDA approval in 2008, its label has warned about the risk for MI.

Just because the FDA has added a drug to its watch list does not mean that the agency has determined that it poses the reported health risk, the agency cautions. Rather, the FDA will investigate whether there is indeed a causal connection. If the answer is yes, the agency would consider a response such as collecting more data to better characterize the risk, revising the drug's label, or requiring a risk-evaluation and mitigation strategy.

The FDA always notes that by adding a drug to the list, it is not suggesting that clinicians should cease prescribing it or that patients should stop taking it.

Regadenoson also made the watch list in 2011 based on possible signals of QT prolongation. The drug's label always has warned about the risk for life-threatening ventricular arrhythmias.

More information on FAERS and its quarterly watch list is available on the FDA Web site.


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