[ RadSafe ] Contrast Agent for Appendicitis Confirmation Linked to Cardiopulmonary Deaths

[Susan Gawarecki]

Contrast Agent for Appendicitis Confirmation Linked to Cardiopulmonary 
Deaths
 
ROCKVILLE, Md., Dec. 2 - The FDA warned today that NeutroSpec, a 
contrast agent used to aid the diagnosis of appendicitis, has been 
linked two deaths from cardiopulmonary failure.

The FDA warning noted that cardiopulmonary reactions occur within 30 
minutes of injection with the agent, which is a murine IgM monoclonal 
antibody to be labeled with Technetium.

In addition to the two deaths, there have been reports of serious 
cardiopulmonary events including "cardiac arrest, hypoxia, dyspnea, and 
hyptension requiring resuscitation with fluids, vassopressors and 
oxygen," the FDA said.

The FDA advised close monitoring of all NeutroSpec patients for at least 
an hour after injection. In addition, clinicians using this agent are 
advised to have resuscitation equipment and appropriately trained 
resuscitation personnel available.

Patients with underlying cardiopulmonary conditions may be at higher 
risk, so use of NeutroSpec in these patients requires careful 
consideration of "known and potential risks and benefits."

NeutroSpec [Technetium (99m Tc) fanolesomab] is used for scintigraphic 
imaging of patients with equivocal signs and symptoms of appendicitis. 
The agent is approved for use in patients age five and older.

Technetium binds with high affinity to polymophonuclear leucocytes which 
migrate to the site of an infected appendix. Technetium emits gamma 
rays, which are detected with a gamma camera, thereby pinpointing the 
infection.

NeutroSpec is marketed by Mallinckrodt, Palatin Technologies.