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Parker & Waichman, LLP Attorneys at Law
NeutroSpec Information Guide
The Case Against NeutroSpec:
NeutroSpec is a radiopharmaceutical imaging agent approved in
the United States for the diagnosis of equivocal appendicitis has
been removed from the market. The manufacturer, Palatin
Technologies Inc. and marketing partner, Mallinckrodt, removed
NeutroSpec after the FDA said the drug can cause severe, lifethreatening reactions in some people. NeutroSpec is injected into
a patient's bloodstream to help doctors diagnose ailments,
Manufacturer:
Palatin Technologies
Date Approved:
September 2004
Status:
Removed 12/19/05
Approved Uses:
Diagnose appendicitis
Serious Side Effects:
Heart failure
Death
Central nervous system
reactions
Infusion reactions
Related Topics:
Defective Drugs
The companies said that two deaths attributed to cardiopulmonary
failure, and additional cases of serious cardiopulmonary events,
occurred to patients within 30 minutes of their injection with
NeutroSpec. The serious cardiopulmonary events included
cardiac arrest, hypoxia, dyspnea, and hypotension. The majority
of the reactions occurred in patients with underlying
cardiopulmonary disease who received NeutroSpec for
unapproved indications. Physicans often prescribe approved
medications for "off-label” use.
NeutroSpec, approved for marketing in July 2004, is a diagnostic
imaging agent that is administered intravenously to help diagnose
appendicitis in patients five years and older with possible
appendicitis who lack its conventional signs and symptoms. The
FDA said the decision to suspend marketing was based on the
life-threatening nature of the associated adverse events, the
unpredictability of the reaction, and availability of other means of
diagnosing appendicitis that do not carry these risks.
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