Warning Issued on NeutroSpec

The marketers of NeutroSpec, an intravenous radiodiagnostic solution that labels white blood cells and myeloid precursors and is used to help diagnose appendicitis, have warned healthcare providers of the occurrence of two deaths and other serious events following its use.

The companies said the deaths occurred within 30 minutes of injecting the agent. The majority of incidents involved patients with cardiopulmonary disease who received NeutroSpec for unapproved applications. NetroSpec has been cleared for use in imaging abdomens of patients five and over who exhibit signs of appendicitis. Other problems observed after the use of NeutroSpec include abnormally low blood pressure and shortness of breath.

NeutroSpec is a radiodiagnostic agent consisting of a murine IgM monoclonal antibody, formulated to be labeled with radioactive Technetium (Tc-99m). The labeled antibody binds with high affinity and specificity to circulating and sequestered neutrophils that congregate at the site of the infected appendix

Mallinckrodt (Hazelwood, MO, USA), a unit of Tyco International, and Palatin Technologies (Cranbury, NJ, USA) noted in a letter dated December 30, 2005, that they are working with the U.S. Food and Drug Administration (FDA) to review the cases and revise safety information in the package insert. The letter noted that for one hour after administration of NeutroSpec, resuscitation equipment and trained personnel must be readily available.




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