[ RadSafe ] Contrast Agent for Appendicitis Confirmation Linked to Cardiopulmonary Deaths
loc at icx.net
Mon Dec 5 14:23:33 CST 2005
Contrast Agent for Appendicitis Confirmation Linked to Cardiopulmonary
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
NeutroSpec is marketed by Mallinckrodt, Palatin Technologies.
More information about the RadSafe