FDA warns of rare but serious risk of heart attack and death with cardiac nuclear stress test drugs Lexiscan (regadenoson) and Adenoscan (adenosine)

Data Summary
 

FDA reviewed the FDA Adverse Event Reporting System (FAERS) database and the medical literature for cases of myocardial infarction (MI) and death from all causes associated with Lexiscan (regadenoson) and Adenoscan (adenosine).  We analyzed FAERS data for Lexiscan from June 24, 2008, to April 10, 2013, and for Adenoscan, from May 18, 1995, to April 10, 2013.  The beginning dates correlated with the start of marketing for each drug.

We identified cases of MI and deaths from all causes for both Lexiscan and Adenoscan. The FAERS database contained 26 MI cases and 29 cases of death occurring after Lexiscan administration, and six cases of MI and 27 cases of death following Adenoscan administration. Reports did not always specify when deaths or MIs occurred.  When reported, these adverse events tended to occur within 6 hours following Lexican or Adenoscan administration.  A few deaths occurred when Lexiscan or Adenoscan was administered with exercise stress testing, which is not an FDA approved use of the drugs.

With Lexiscan, the most common adverse events associated with death were cardiac arrest, MI, loss of consciousness, respiratory arrest, electrocardiogram ST segment depression, pulmonary edema, and ventricular fibrillation.  With Adenoscan, the most common adverse events associated with death were cardiorespiratory arrest, dyspnea, cardiac arrest, respiratory arrest, and ventricular tachycardia. 

The number of postmarketing reports is subject to change over time, and may not reflect the true proportion of cases associated with either Lexiscan or Adenoscan.  Many factors can influence whether adverse effects are reported, particularly the length of time a drug has been marketed, whether or not the adverse effect is described in the drug label, and the amount of publicity about an event or safety concern.  Specifically for Lexiscan and Adenoscan, the analysis is complicated by differences in the number of patient exposures and in underlying cardiac risk factors that can influence choice of drug, and for Adenoscan, by its longer time on the market.

Medical Literature Review

A review of the medical literature also identified two case reports of MI associated with Lexiscan.^1,2  However, published studies from the medical literature have not documented an increased incidence of cardiovascular adverse events with Lexiscan compared to Adenoscan.^3-7