NeutroSpec Linked to Cardiopulmonary Events

You could be at risk for serious and life-threatening events if you have any underlying cardiopulmonary conditions and your healthcare provider uses NeutroSpec [Technetium (99m Tc) fanolesomab] when doing bone scans or other imaging procedures.

The manufacturer and the FDA have reported some serious events when a radiodiagnostic agent consisting of a murine IgM monoclonal antibody formulated to be labeled with technetium was used. These events generally occurred within minutes of injection. Two deaths have been attributed to cardiopulmonary failure within 30 minutes of injection. Additional cardiopulmonary events, including cardiac arrest, hypoxia, dyspnea and hypotension, required resuscitation with fluids, vasopressors, and oxygen.

Although this agent is indicated for scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older, some healthcare professionals may be using it for bone scans for people with CRPS.

If you are using NeutroSpec, you should be closely monitored for at least one hour following injection. Resuscitation equipment and appropriately trained personnel must be readily available during this time. If you have any underlying cardiopulmonary conditions you may be at higher risk for serious complication. You should only use NeutroSpec after carefully considering the known and potential risks and benefits.

Access this alert at:
http://www.fda.gov/medwatch/safety/2005/safety05.htm#NeutroSpec