Two Heart Stress Test Drugs Restricted by the FDA

The FDA recently informed healthcare providers throughout the U.S. to avoid using heart stress test drugs manufactured by Astellas Pharma due to reports of heart attacks and deaths in patients. The drugs, Adenoscan and Lexiscan, are injected to determine whether patients have blocked heart arteries. Dangerous drug attorneys at Pintas & Mullins Law Firm warn cardiac patients about this recent restriction and urge them to make sure they are not administered Adenoscan or Lexiscan.

The drugs are meant to increase blood flow to the heart so that, during cardiac stress tests, physicians can more easily identify weaknesses in the arteries. Unfortunately, this also causes blood to flow more to the healthier cardiac arteries and away from the blocked or diseased ones, potentially causing severe, sometimes fatal heart attacks.

As a result, the FDA notes that Adenoscan and Lexiscan are most dangerous in patients with symptoms of acute myocardial ischemia, which is the medical term for blocked and oxygen-starved heart arteries. Symptoms of this condition include pain or pressure in the chest, clammy skin, nausea, neck or jaw pain, shortness of breath, and pain in the shoulder or arm.

According to the Mayo Clinic, causes of myocardial ischemia include blood clots, coronary artery disease or spasm, and severe illnesses or infections. Risk factors for developing these ailments include tobacco use, diabetes, having high blood pressure, cholesterol or triglyceride levels, being obese, lack of exercise, and having a family history of cardiac problems.

The FDA also recommends that healthcare professionals keep cardiac resuscitation equipment on-hand and staff nearby before either drug is administered to any patient. The agency plans to update the labels on both drugs to indicate the increased cardiac risks.

In September 2013, the FDA placed Adenoscan and Lexiscan on its list of drugs to closely monitor. This was done after a surge in negative health events were reported by patients using the drugs. The FDA reviewed its adverse event reporting system data and found nearly 30 patient fatalities and over 25 reports of myocardial infarction from Lexiscan alone. Adenoscan was associated with 27 deaths. These numbers are also underreported, as the FDA reporting system is entirely voluntary.

On average, the cardiac events occurred within six hours after stress tests, and a few occurred after exercise stress testing, which the drugs are not approved for. Along with cardiac arrests, Lexiscan patients suffered from loss of consciousness, respiratory arrest and heart attacks; Adenoscan patients experienced cardiorespiratory arrests, ventricular tachycardia (faster than normal heart rate), and shortness of breath.

Three years ago, in 2010, Astellas was accused of violating federal antitrust laws by creating a stress test process which required healthcare professionals to purchase Adenoscan despite the availability of generics. The lawsuit was brought by Lakeland Regional Medical Center in Florida.

Our team of dangerous drug lawyers urges patients about to undergo cardiac stress tests to make sure that they will not be administered Adenoscan or Lexiscan manufactured by Astellas Pharma. If you or a loved one suffered a serious cardiac event after being injected with these drugs, contact our firm today for a free legal consultation to see if you are eligible for financial compensation.


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