FDA Sounds Alarm on NeutroSpec

An innovative new way of rapidly imaging sites of infection — specifically, appendicitis — has sustained a major setback. The FDA has issued a warning on the NeutroSpec system:

NeutroSpec, approved for marketing in July 2004, 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…
…The adverse event reports submitted to FDA as part of the agency’s routine postmarket surveillance of all medical products revealed cases where NeutroSpec caused allergic type reactions that occurred within minutes following NeutroSpec administration.
These reactions led to the death of two patients, and to cardiopulmonary failure, central nervous system reactions, and infusion reactions in other patients.

Before this, NeutroSpec sounded pretty cool:

NeutroSpec consists of a technetium-99-labeled anti-CD 15 monoclonal antibody which selectively binds to neutrophils. It allows physicians can rapidly image and detect infection with the gamma camera. NeutroSpec offers in-vivo labeling of white blood cells, leading to a rapid and highly specific functional image of an infection in less than an hour, while the current standard of care provides images only after a 12 to 24-hour incubation.

In response to these catastrophic reactions, Mallinckrodt Imaging, the distributor, has withdrawn NeutroSpec from the market.
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