“Dear Doctor” Letter Cautions About Cardiopulmonary Events With NeutroSpec
This article was originally published in The Pink Sheet Daily
Executive Summary
Letter from Mallinckrodt and Palatin alerts healthcare providers to serious cardiopulmonary events that may occur within minutes of injection with the imaging agent.
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Mallinckrodt and Palatin Technologies have issued a "Dear Healthcare Provider" letter for the injectable imaging agent NeutroSpec , warning physicians of the potential for serious cardiopulmonary events. The letter, issued Nov. 30, cites two deaths that occurred due to cardiopulmonary failure and other "serious cardiopulmonary events including cardiac arrest, hypoxia, dyspnea, and hypotension." These events generally occurred within minutes of the injection and in patients with "underlying cardiopulmonary disease who receive NeutroSpec for unapproved indications," the letter said. The firms also warn that those patients with underlying cardiopulmonary conditions "may be at a higher risk for serious complication." NeutroSpec was approved in July 2004 for scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older (1 (Also see "Palatin/Mallinckrodt Neutrospec Clears FDA; Imaging Agent Available In Mid-August" - Pink Sheet, 6 Jul, 2004.)). Mallinckrodt and Palatin said they will work with FDA to review the adverse event reports and "revise the NeutroSpec U.S. package insert to provide additional Warnings and safety information." -Kathryn Phelps |