FDAnews Device Daily Bulletin


Dec. 20, 2005

Palatin Technologies has suspended sales, marketing and distribution of its appendicitis diagnostic imaging agent NeutroSpec until the FDA undertakes a review of reported deaths and serious adverse events associated with the product.

The FDA requested the market withdrawal and issued a public health advisory urging healthcare providers to discontinue the use of NeutroSpec (technetium (99m TC fanolesomab). Reported adverse events have revealed cases in which NeutroSpec caused allergic type reactions that occurred within minutes following administration of the product, the FDA said. "These reactions lead to the deaths of two patients, and to cardiopulmonary failure, central nervous system reactions, and infusion reactions in other patients," the agency said.

Palatin and its marketing partner Mallinckrodt said they had reported several serious adverse events involving patients with severe underlying cardiopulmonary compromise who received NeutroSpec for off-label use. Approved in July 2004, NeutroSpec is a diagnostic imaging agent that is administered intravenously to help diagnose appendicitis in patients five years and older with possible appendicitis who lack its conventional signs and symptoms, according to the FDA.

At a recent meeting, the FDA informed Palatin and Mallinckrodt that it had reconsidered the risk/benefit assessment of NeutroSpec and determined the product should not be administered to patients until a further understanding and review of the relationship between NeutroSpec and reported serious adverse events is complete, Palatin said. "Although the companies believe that these safety concerns could potentially be addressed in other ways, they have agreed to voluntarily take the actions requested by the FDA," said Palatin.

The FDA plans to hold an advisory panel meeting early next year to discuss the use of NeutroSpec with additional safeguards, and evidence needed to continue use of the product for equivocal appendicitis, as well as plans for other indications, most notably being osteomyelitis.

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