FDA Warns of Heart Attack, Death Risk With Stress Test Drugs Lexiscan, Adenoscan

The Food and Drug Administration Nov. 20 warned health-care professionals of a rare but serious risk of heart attack and death with the use of the cardiac nuclear stress test agents Lexiscan (regadenoson injection) and Adenoscan (adenosine injection).

The agency said it approved changes to the drug labels to reflect these serious events and has updated its recommendations for use of these agents. Both products are made by Astellas Pharma US Inc., which is based in Northbrook, Ill.

Lexiscan and Adenoscan are approved for use during cardiac nuclear stress tests in patients who can’t exercise adequately, the agency said. The ...