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NeutroSpec (Technetium [99m Tc] fanolesomab)

December 2, 2005

Audience: Medical imaging specialists, hospital administrators and risk managers

[UPDATE Posted 12/19/2005] FDA issued a Public Health Advisory to alert patients and health care providers that Palatin Technologies Inc. and Mallinckrodt have agreed to implement an immediate voluntary market suspension due to serious safety concerns, making NeutroSpec unavailable for approved or investigational uses. FDA urges health care providers to discontinue use of existing stocks of NeutroSpec and to contact Palatin Technologies regarding their return. FDA is conducting further investigation into the deaths and adverse events associated with NeutroSpec and is working closely with the manufacturers of the product to evaluate the risks and benefits associated with its use.

[Posted 12/02/2005] Mallinckrodt, Palatin Technologies and 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 IgM 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 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 one 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.

[November 30, 2005 - Letter - Mallinckrodt/Palatin]

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