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Richard R. Schlueter
Richard R. Schlueter
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NeutroSpec Warning Leads to Recall

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On December 19th the FDA identified that serious safety concerns exist with a drug administered to patients for diagnostic imaging. This drug has been approved for marketing only since June 2004 and is administered intravenously. The drug is used to detect appendicitis in patients five years of age and older. The drug Neutrospec is manufactured by Palatin Technologies. The FDA received reports of at least 2 deaths and 15 other life threatening events within minutes of administration of neutrospec. The adverse events included shortness of breath, low blood pressure and cardiac arrest.

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. The FDA acknowledges that many cases may go unreported and urges health care providers and patients to report adverse events to via the medwatch program. Reports can be made by phone at 1800 FDA 1088 or fax at 1 800 FDA 0178. You can see the official bulletin of the FDA concerning Neutrospec at the following link.

Neutrospec Recall