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NeutroSpec [Technetium (99m Tc)
fanolesomab] Information
Palatin Technologies and the FDA have agreed on the immediate
suspension of sales and marketing of NeutroSpec [Technetium (99m Tc)
fanolesomab] in the United States, due to reports of serious and
life-threatening cardiopulmonary events following the administration
of the drug. NeutroSpec is used for radionuclide imaging of patients
with equivocal signs and symptoms of appendicitis. NeutroSpec has
also been used for certain unapproved indications, such as the
detection of osteomyelitis and other infections. Onset of these
serious events generally occurred within minutes of administering
the drug and there have been two deaths attributed to
cardiopulmonary failure. Patients have experienced other serious
cardiopulmonary events, including cardiac arrest, hypoxia, dyspnea
and hypotension, and required resuscitation with fluids,
vasopressors, and oxygen. All of the reactions occurred
immediately after NeutroSpec was administered. There is no evidence
that patients who already safely received the drug face any
long-term risk.
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Date created: December 19, 2005 |
