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FDA Orders Withdrawal of Diagnostic Imaging Agent

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Diagnostic imaging agent NeutroSpec has been withdrawn from the market by order of the Food and Drug Administration. The drug has been tied to numerous adverse allergic-type responses shortly after injection, including 2 deaths.

The United States Food & Drug Administration has ordered the withdrawal of NeutroSpec, a diagnostic imaging agent used for diagnosis of suspected cases of appendicitis in patients over the age of five years, according to an alert sent Friday from MedWatch, the FDA’s safety information and adverse event reporting program. In an announcement posted on the FDA safety warnings website on December 19, 2005, the FDA advised that NeutroSpec appears to have been the cause of severe allergic-type reactions within minutes following its administration.

The United States Food & Drug Administration has ordered the withdrawal of NeutroSpec, a diagnostic imaging agent used for diagnosis of suspected cases of appendicitis in patients over the age of five years, according to an alert sent Friday from MedWatch, the FDA’s safety information and adverse event reporting program. In an announcement posted on the FDA safety warnings website on December 19, 2005, the FDA advised that NeutroSpec appears to have been the cause of severe allergic-type reactions within minutes following its administration.

According to an alert posted on the Medscape website, onset of these events generally occurred within minutes of injection and included cardiac arrest, hypoxia, dyspnea, and hypotension requiring resuscitation with fluids, vasopressors, and oxygen, according to an alert sent Friday from MedWatch, the FDA’s safety information and adverse event reporting program.

In addition, 2 deaths occurring within 30 minutes of product injection have been attributed to cardiopulmonary failure. NeutroSpec is a product of Mallinckrodt and Palatine Technologies, Inc., and has been approved for marketing since July, 2004.

Diagnostic contrast agents are among the most common causes of severe anaphylactic reactions, but it is unclear whether the adverse events reported as related to the use of NeutroSpec constitute a similar type event or an entirely different type of allergic reaction.

Diagnostic imaging agent Neutrospec linked to cardiopulmonary failure

FDA announces that it has suspended the marketing of NeutroSpec

“Dear Doctor” Letter re: NeutroSpec from Mallinckrodt and Palatine Technologies, Inc:

Article from the Cleveland Clinic regarding anaphylaxis

Table: Most common causes of anaphylaxis