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Title: Reports of Serious and Life-threatening Cardiopulmonary Events with Imaging Agent NeutroSpec (Technetium [99m Tc] fanolesomab)

"Reports of Serious and Life-threatening Cardiopulmonary Events with Imaging Agent NeutroSpec (Technetium [99m Tc] fanolesomab)"

BETHESDA, MD -- December 5, 2005 -- Mallinckrodt, Palatin Technologies and U.S. Food and Drug Administration (FDA) notified healthcare professionals of postmarketing reports of serious and life-threatening cardiopulmonary events following the administration of NeutroSpec (Technetium [99m Tc] fanolesomab), a radiodiagnostic agent consisting of a murine Immunoglobulin M monoclonal antibody formulated to be labeled with technetium, indicated for scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older. Onset of these cardiopulmonary events generally occurred within minutes of injection and included two deaths attributed to cardiopulmonary failure within 30 minutes of injection. Additional cases of serious cardiopulmonary events including cardiac arrest, hypoxia, dyspnea and hypotension required resuscitation with fluids, vasopressors, and oxygen. Any patient who receives NeutroSpec should be closely monitored for at least 1 hour following product administration. Resuscitation equipment and appropriately trained personnel must be readily available during this time. Patients with underlying cardiopulmonary conditions may be at higher risk for serious complication. NeutroSpec administration to these patients should only follow careful consideration of the known and potential risks and benefits, including the possibly higher risks. Read the complete MedWatch 2005 Safety summary, including links to the Dear Healthcare Professional letter and current prescribing information, at: http://www.fda.gov/medwatch/safety/2005/safety05.htm#NeutroSpec SOURCE: U.S. Food and Drug Administration

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