FDA Restricts Use Of 2 Astellas Heart Test Drugs

Law360, New York (November 20, 2013, 4:54 PM EST) -- The U.S. Food and Drug Administration on Wednesday advised health care providers to avoid two Astellas Pharma Inc. cardiac stress test drugs in patients with weaker hearts and strengthened the drugs' warning labels in response to reported instances of heart attack and death.

Based on adverse event reports, the FDA said it had linked the cardiac nuclear stress test agents Adenoscan and Lexiscan to a rare but serious risk of myocardial infarction in patients with preexisting cardiac instability. Introduced in 1995 and 2008, respectively, the injectable...
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