FDA warns of MI with cardiac nuclear stress test agents

November 22, 2013

FDA is warning healthcare professionals of the rare but serious risk of heart attack and death with use of cardiac nuclear stress test agents regadenoson (Lexiscan) and adenosine (Adenoscan).

FDA is warning healthcare professionals of the rare but serious risk of heart attack and death with use of cardiac nuclear stress test agents regadenoson (Lexiscan) and adenosine (Adenoscan). 

Regadenoson and adenosine are used in the diagnosis of coronary artery disease in patients who cannot exercise adequately. The drugs are used during cardiac nuclear stress tests to dilate the arteries of the heart and increase blood flow to help identify blockage within the heart. These stress test agents cause blood to flow preferentially to the healthier, 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 recent FDA reports of myocardial infarction and death related to the use of Lexiscan and Adenoscan in cardiac stress tests are a cause for concern, so it is important for prescribers to be mindful of these risks and carefully assess the risk versus benefit of use particularly as it relates to their use for cardiac stress tests/exercise stress testing,” said Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala. “Prescribers may also want to consider alternative agents as indicated by FDA when these tests must be performed in certain patients.”

Recent reports of serious adverse events in the FDA Adverse Event Reporting System (FAERS) database and the medical literature prompted FDA to approve changes to the drug labels to include updated recommendations for use.  FDA has approved changes to the drug labels to reflect these serious events and updated its recommendations for use of these agents. Healthcare 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.   

The Warnings & Precautions section of the regadenoson and adenosine labels previously contained information about the possible risk of heart attack and death with use of these drugs. Cardiac resuscitation equipment and trained staff should be available before administering these drugs.  At this time, data limitations prevent FDA from determining if there is a difference in risk of heart attack or death between regadenoson and adenosine.