FDA issues warning about risks with cardiac nuclear stress test drugs

The FDA has issued a safety announcement warning health care professionals of rare but serious risk for MI and death with the use of the cardiac nuclear stress test agents regadenoson and adenosine. The agency recommends avoidance of these drugs in patients with signs or symptoms of unstable angina or CV instability due to greater risk for serious CV adverse reactions.

According to a statement, the FDA approved changes to the regadenoson (Lexiscan, Astellas) and adenosine (Adenoscan, Astellas) drug labels to reflect the potential for these serious events. The drug labels previously contained information about the possible risk for MI and death.

Lexiscan and Adenoscan are FDA approved for use during cardiac nuclear stress tests in patients who cannot exercise adequately.

The safety announcement and label update were the result of recent reports of serious adverse events in the FDA Adverse Event Reporting System (FAERS) database and the medical literature. Some events occurred following the administration of Lexiscan injection or Adenoscan infusion in patients with signs or symptoms of acute myocardial ischemia. Due to limitations in the currently available data, the FDA said it is unable to discern a difference in risk for acute MI or death between the two drugs, according to the statement.

The FDA recommends that cardiac resuscitation equipment and trained staff should be available before administration of Lexiscan or Adenoscan. Health care professionals are also encouraged to report related adverse events to the FDA MedWatch program.