FDA Confirms Serious Risk of Heart Attack and Death with Cardiac Nuclear Stress Test Agents
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
By Amy O'Callaghan
As a litigation firm representing people for injuries caused by defective medical devices and drugs, we wanted to share the following reports of serious risk of heart attacks and death arising from the use of Lexiscan (regadenoson) and Adenoscan (adenosine). This was announced through an urgent FDA Safety Communication.
Both drugs are cardiac nuclear stress agents. These agents reduce blood flow to obstructed arteries and divert blood flow into healthier arteries. It is this reduced blood flow, however, that can lead to heart attacks or even death.
The shocking results which have emerged have brought about usage recommendation changes for both drugs. It is now recommended that patients undergo prior screening to access suitability for the drugs. Patients showing signs or symptoms of unstable angina or cardiovascular instability should be deemed not suitable for the drug. These recommendations also state that the drugs should not be administered without the presence of cardiac resuscitation equipment and trained staff. This is reminiscent of our firm's General Electric Healthcare Omniscan gadolinium litigation where the MRI agent caused deaths and serious injuries in patients with kidney problems. Settlements and trial verdicts were well over a million dollars in the more serious cases.