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Drug & Device News

By ALM Staff | Law Journal Newsletters |

Diagnostic Imaging Agent Pulled from Market

The FDA has issued a Public Health Advisory to inform health care providers 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. NeutroSpec, approved for marketing in July 2004, is a diagnostic imaging agent administered intravenously to help diagnose appendicitis in patients 5 years and older with possible appendicitis who lack its conventional signs and symptoms. News of these adverse events, including severe allergic reactions in certain patients shortly after being administered NeutroSpec, were reported to the FDA as part of the agency's post-market surveillance program. As all of the reactions occurred immediately after Neutro-Spec was administered, there is no indication that patients who already safely received the drug face any long-term risk.

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