Health Advisory Issued on Appendicitis Imaging Agent




Health Advisory Issued on Appendicitis Imaging Agent

The FDA has issued a worldwide health advisory to stop using a product called NeutroSpec  (Technetium (99m TC) Fanolesomab), a diagnostic imaging agent.  The product has been linked to several reports of deaths and other serious side effects associated with it.  The agent is used in diagnosing appendicitis.

The company who makes the agent has said that it is complying with the FDA request and will stop making the product and has asked that hospitals and other medical facilities stop using NeutroSpec. 

Reactions to NeutroSpec included allergic reactions that happened in just minutes after the agent was given to the patients.  Other serious side effects included cardiopulmonary failure, central nervous system reactions, and other infusion reactions.

The results of studies given to the FDA before NeutroSpec was on the market suggested that the product was safe and that there were no adverse side effects.  Some side effects were noted but those were only when NeutroSpec was used “off-label.”  The FDA approved NeutroSpec in July of 2004.

NeutroSpec was designed to diagnose appendicitis in people who didn’t have obvious signs of the disease. 

The FDA is urging all persons and institutions involved in the administration of NeutroSpec to discontinue its use immediately until further studies are completed. 


 

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