Public health advisory issued on NeutroSpec

December 26, 2005

The FDA has issued a public health advisory to alert healthcare professionals that the agency has requested the market withdrawal of the diagnostic imaging agent NeutroSpec (technetium [99m Tc] fanolesomab) pending review of reported deaths and serious and life-threatening adverse events associated with use of the product. The manufacturer, Palatin Technologies, and marketing partner, Mallinckrodt, have agreed to implement voluntary market suspension, making the product unavailable for approved or investigational uses. NeutroSpec is a diagnostic imaging agent that is administered intravenously to help diagnose appendicitis in patients aged five years and older with possible appendicitis who lack its conventional signs and symptoms.