FDA Public Health Advisory
Suspended Marketing of NeutroSpec (Technetium (99m Tc)
fanolesomab)
This product is not currently available for purchase in the U.S.
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FDA is issuing this public health advisory to inform patients and
health care providers that Palatin Technologies, the manufacturer of
NeutroSpec (Technetium (99m Tc) fanolesomab) is voluntarily
suspending marketing of NeutroSpec effective immediately due to
serious safety concerns. NeutroSpec is indicated for radiologic
imaging of patients with unclear signs and symptoms of appendicitis
who are five years of age and older.
FDA received reports from Palatin Technologies of 2 deaths and 15
additional life-threatening adverse events in patients receiving
NeutroSpec. These events occurred within minutes of administration
of NeutroSpec and included shortness of breath, low blood pressure,
and cardiopulmonary arrest. Affected patients required resuscitation
with intravenous fluids, blood pressure support, and oxygen. Most,
but not all, of the patients who experienced these events had
existing cardiac and/or pulmonary conditions that may have placed
them at higher risk for these adverse events. A review of all
post-marketing reports showed an additional 46 patients who
experienced adverse events that were similar but less severe. 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.
The relationship between NeutroSpec and these events has not been
definitively determined. However, the consistent characteristics and
rapid onset of these events following NeutroSpec injection makes it
likely that they were due to administration of NeutroSpec.
NeutroSpec is an antibody radio-labeled with technetium-99m. There
is no indication that the radiopharmaceutical component of
NeutroSpec, technetium-99m, was related to occurrence of these
events.
The decision to suspend marketing was based on the
life-threatening nature of the events and the availability of other
means to diagnose appendicitis that do not carry these risks. FDA
urges health care providers to discontinue use of existing stocks of
NeutroSpec and to contact Palatin Technologies regarding their
return.
NeutroSpec was approved in June 2004 for imaging of patients with
equivocal signs and symptoms of appendicitis who are five years of
age or older. Market approval was based on a total of 523 subjects;
and adverse events of the severity described above were not observed
pre-marketing. The 17 patients who experienced the serious events
received NeutroSpec to diagnose infections other than appendicitis.
It is not known what, if any, risk factors might increase the
likelihood of such events. The FDA will work closely with Palatin
Technologies to evaluate these adverse events and their potential
relationship to NeutroSpec. The FDA will notify health care
providers and patients in a timely fashion as new information
becomes available.
The FDA urges health care providers and patients to report
adverse event information associated with this or any medical
product to FDA via the MedWatch program by phone (1-800-FDA-1088),
by fax (1-800-FDA-0178), or by the Internet at
http://www.fda.gov/medwatch/index.html.
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Date created: December 19, 2005, updated July, 2007 |