Neutrospec

NeutroSpec (Technetium fanolesomab) is a monoclonal antibody manufactured by Palatin Technologies and used in radiological imaging.

History and Use

NeutroSpec was approved by the FDA in June 2004 for imaging of patients with symptoms of appendicitis. It consisted of a monoclonal antibody against CD15. The antibody was labeled with technetium-99 so as to be visible on a gamma camera. Since anti-CD15 antibodies bind selectively to Neutrophils it could be used to localize the site of an infection.

Deaths and Associated Recall

The FDA received reports from Palatin Technologies of 2 deaths and 15 additional life-threatening adverse events in patients receiving NeutroSpec. These events occurred within minutes of administration of NeutroSpec and included shortness of breath, low blood pressure, and cardiopulmonary arrest. Affected patients required resuscitation with intravenous fluids, blood pressure support, and oxygen. Most, but not all, of the patients who experienced these events had existing cardiac and/or pulmonary conditions that may have placed them at higher risk for these adverse events. A review of all post-marketing reports showed an additional 46 patients who experienced adverse events that were similar but less severe. All of the reactions occurred immediately after NeutroSpec was administered.

Marketing of the product was suspended in December of 2005.