Company Recalls NeutroSpec Imaging Agent After Deaths
Two deaths and many adverse events linked to imaging agent used in appendicitis diagnosis
MONDAY, Dec. 19 (HealthDay News) -- Acting at the request of the U.S. Food and Drug Administration, the makers of NeutroSpec (Technetium 99m Tc fanolesomab), an imaging agent approved to diagnose appendicitis, are voluntarily withdrawing the product from the market.
The action came after reports of two deaths and at least 15 "serious and life-threatening" adverse events linked to use of NeutroSpec, the agency said.
The serious adverse events included cardiopulmonary failure, central nervous system reactions and infusion reactions. In addition, there were 46 other patients who had similar but less severe reactions. Most of the patients ranged in age from 45 to 80 and older, although one was a teenager.
The reactions occurred within minutes of the drug's administration by injection. NeutroSpec is a murine monoclonal antibody tagged with Technetium. The product is made by Palatin Technologies Inc. and marketed by Mallinckrodt.
The FDA approved NeutroSpec in July 2004 to help diagnose appendicitis in patients aged 5 years and older who do not have the typical signs of appendicitis.
The FDA is urging all health-care providers to stop using NeutroSpec and to contact either the company or their distributor about returning existing stocks.