FDAnews Drug Daily Bulletin

MEDWATCH ALERT ISSUED ON NEUTROSPEC

Dec. 13, 2005
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The FDA has issued a MedWatch alert for Mallinckrodt and Palatin Technologies' imaging agent NeutroSpec, following reports that patients taking the drug suffered serious and life-threatening cardiopulmonary events.

Mallinckrodt and Palatin disseminated a "Dear Healthcare Provider" letter late last month to inform physicians they had been alerted to two deaths attributed to cardiopulmonary failure within 30 minutes of injection with NeutroSpec (technetium fanolesomab). The imaging agent was also associated with additional cases of serious cardiopulmonary events including cardiac arrest, hypoxia, dyspnea and hypotension.

"Onset of these events generally occurred within minutes of injection and required resuscitation with fluids, vasopressors and oxygen," the letter states. "The majority of these reports described patients with underlying cardiopulmonary disease who received NeutroSpec for unapproved indications."

The companies said they are working with the FDA to review the adverse events and revise the NeutroSpec package insert to provide additional safety data. Approved by the FDA in July 2004, NeutroSpec is a radiolabeled monoclonal antibody imaging agent, for the diagnosis of equivocal appendicitis in patients five years and older.