FDA Orders NeutroSpec Withdrawn from Market After 2 Deaths

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The FDA has ordered the withdrawal of the diagnostic imaging agent Neutro Spec after two reported deaths were associated with the product. Reports submitted to the FDA suggest NeutroSpec caused allergic reactions within minutes following administration. Those reactions led to the death of two patients and to cardiopulmonary failure, central nervous system problems and infusion reactions in other patients.

FDA officials emphasized all of the reactions occurred immediately after NeutroSpec was administered and there is no evidence that patients who already safely received the drug face any long-term risk.

NeutroSpec, approved for marketing in July 2004, is a diagnostic imaging agent that's administered intravenously to help diagnose appendicitis in patients 5 years and older.