The U.S. Food and Drug Administration (FDA) is warning the public that the nuclear stress test agent regadenoson—sold under the brand name Lexiscan—might cause heart attacks or death.
What Is Lexiscan and What Is It Prescribed For?
Lexiscan is the brand name for the drug regadenoson. Made and sold by Astellas Pharma US, Inc., the U.S. arm of the Japanese company Astellas Pharma Inc., this prescription medication is used for cardiac nuclear stress tests. The FDA approved it as an intravenous injection in April 2008.
Doctors order cardiac stress tests for their patients to detect heart problems. Normally this is done by comparing the patient’s coronary circulation (circulation in the heart) at rest and then after exercising. The better the blood flow within the heart, the healthier the patient is overall.
Some patients who are incapable of exercise cannot undergo traditional stress tests. To test their coronary circulation, doctors must inject them with a compound like Lexiscan that dilates their blood vessels to help cardiologists detect obstructions with special imaging equipment.
Lexiscan Might Cause Heart-Attack Side Effects and Death
On November 20, 2013, the FDA issued a drug safety communication warning the public that it had received a substantial number of adverse event reports from patients who had been injected with Lexiscan and subsequently suffered heart attacks or death. From June 24, 2008, until April 10, 2013, the agency received 26 reports of myocardial infarction concerning patients injected with Lexiscan. Another 29 patients died under similar circumstances.
Not all the reports specified how long after the injection the adverse events occurred, but when it did appear the time was often within six hours of the injection. Another cardiac nuclear stress test agent, Adenoscan (adenosine), also appeared in the report as causing injuries to patients. The FDA listed the following symptoms as common in patients who died after a Lexiscan injection:
- Cardiac arrest
- Myocardial infarction
- Loss of consciousness
- Respiratory arrest
- Electrocardiogram ST segment depression
- Pulmonary edema
- Ventricular fibrillation
As a result of the drug safety communication, the FDA updated Lexiscan’s drug label.
The agency believes that Lexiscan’s tendency to dilate blood vessels causes blood to flow to more open arteries. Arteries that are obstructed receive less blood, which can lead to fatal heart problems.
RLG’s Lexiscan Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Lexiscan lawsuit on your behalf if necessary. RLG will also keep you up to date on any Lexiscan class action lawsuits, additional FDA Lexiscan warnings, and Lexiscan FDA recall announcements. If you or a loved one received a Lexiscan injection, and you believe it caused an injury, contact RLG today.