Lexiscan (regadenoson) was associated with 26 heart attacks and 29 deaths from June 2008 to April 2013. The FDA warns that patients may be at risk of death during cardiac stress tests, which are used to measure blood flow to the heart muscle. In November 2013, the FDA strengthened warnings about the risk of heart attack and death from Lexiscan.
What is Lexiscan?
Lexiscan (regadenoson) is a prescription medication that increases blood-flow to coronary arteries in the heart. It is administered intravenously (IV) in a hospital setting during a cardiac stress test, which is used to measure blood-flow to the heart muscle at rest and during exercise.
About 50% of people who undergo a cardiac stress test are unable to use a treadmill or stationary bicycle due to underlying conditions. Lexiscan is administered to these patients to simulate stress on the heart and provide images that can help diagnose heart disease. Lexiscan dilates coronary arteries, which increases blood-flow so obstructions can be identified.
What is the problem with Lexiscan?
The problem with Lexiscan is that it may cause blood to flow preferentially to healthy, unblocked, or unobstructed arteries. This can reduce blood-flow in the obstructed artery, which can potentially cause a deadly heart attack.
FDA Safety Warning for Lexiscan Heart Attacks and Death
November 20, 2013 — The FDA has issued a Safety Announcement to warn about the risk of heart attack and death from Lexiscan and Adenoscan. The FDA recommends that Lexiscan should not be used in patients with unstable angina (chest pain caused by reduced blood-flow and oxygen to the heart) or cardiovascular instability.
Prescribing Information Warning for Heart Attacks
The new FDA warnings strengthen pre-existing warnings on the label for Lexiscan. According to the Prescribing Information:
“Myocardial Ischemia: Fatal cardiac events have occurred. Avoid use in patients with symptoms or signs of acute myocardial ischemia, for example unstable angina or cardiovascular instability, who may be at greater risk. Cardiac resuscitation equipment and trained staff should be available before administration.”