Imaging Agent for Diagnosis of Appendicitis Recalled

Appendicitis Recalled

Marketing for technetium 99m fanole-somab (NeutroSpec, Palatin Technologies) is being suspended immediately because of safety concerns. NeutroSpec is an antibody radiolabeled with tech-netium-99m, indicated for radiological imaging of patients five years of age or older with unclear signs and symptoms of appendicitis.

The agent carries a radioactive tracer to white blood cells and binds to them. A radioactivity-spotting camera is used to determine whether the white blood cells have clustered in the appendix, a sign of infection.

The FDA received reports from Palatin of two deaths and 15 additional life-threatening adverse events in patients receiving NeutroSpec. These events occurred within minutes of administration and included shortness of breath, low blood pressure, and cardio-pulmonary arrest. An additional 46 patients experienced adverse events that were similar but less severe. Most of the adverse effects occurred when Neutro-Spec was used to diagnose infections other than appendicitis.
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Health care providers should discontinue their use of existing stocks and contact Palatin regarding their return.

The FDA plans to debate whether additional safety measures would allow the agent to return to the market.