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FDA: Prussian Blue for Internal Contamination with Thallium or Cesium
Susan and all,
In consideration of a possibility that this topic may become a tread, I would suggest a change in its title from "FDA: Prussian Blue as Tmt for Exposure to Radioactive Exposures". FDA issued a guidance on the topic just a few days following the cited release (Federal Register, Vol.68, Number 23, February 4, 2003). It contains a curious statement "...Cesium-137 is a product of fusion..." - (pasted below) - interesting.
Jodi Strzelczyk, Ph.D.
University of Colorado HSC
Asst. Professor, Radiological Sciences
...Date: Wed, 02 Apr 2003 15:52:15 -0500
From: Susan L Gawarecki <loc@icx.net>
Subject: FDA: Prussian Blue as Tmt for Exposure to Radioactive Exposures
FOR IMMEDIATE RELEASE
PO3-06
January 31, 2003
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
FDA ENCOURAGES NEW DRUG APPLICATION SUBMISSIONS FOR PRUSSIAN BLUE AS A
TREATMENT FOR THALLIUM OR RADIOACTIVE CESIUM CONTAMINATION...
Susan L. Gawarecki, Ph.D., Executive Director
Oak Ridge Reservation Local Oversight Committee
102 Robertsville Road, Suite B, Oak Ridge, TN 37830
Toll free 888-770-3073 ~ www.local-oversight.org
------------------------------------------------from: Federal Register 68 (23), Feb 4, 2003
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 03D-0023]
Guidance for Industry on Prussian Blue for Treatment of Internal
Contamination With Thallium or Radioactive Cesium; Availability
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that we
have concluded that prussian blue, when produced under conditions
specified in approved new drug applications (NDAs), can be found to be
safe and effective for the treatment of internal contamination with
radioactive thallium, nonradioactive thallium, or radioactive cesium.
We encourage the submission of NDAs for prussian blue drug products. We
are also announcing the availability of a guidance for industry
entitled ``Prussian Blue Drug Products--Submitting a New Drug
Application.'' This guidance is intended to assist manufacturers who
plan to submit NDAs for prussian blue.
ADDRESSES: Submit NDAs to the Food and Drug Administration, Center for
Drug Evaluation and Research, Central Document Room, 12229 Wilkins
Ave., Rockville, MD 20852. Submit requests for copies of draft labeling
to the Division of Medical Imaging and Radiopharmaceutical Drug
Products, (HFD-160), Center for Drug Evaluation and Research, Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
7510. Copies of the reports referred to in this document will be on
display at the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the guidance to the
Division of Drug Information (HFD-240), Center for Drug Evaluation and
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville,
MD 20857. Send one self-addressed adhesive label to assist that office
in processing your requests. Submit written comments on the guidance to
the Dockets Management Branch (address provided in third sentence of
this paragraph). Submit electronic comments to
http://www.fda.gov/dockets/ecomments
FOR FURTHER INFORMATION CONTACT: Kyong Kang, Center for Drug Evaluation
and Research (HFD-160), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-827-7510.
SUPPLEMENTARY INFORMATION:
I. Background
A. Cesium
Cesium-137, a radioactive isotope of cesium, was discovered in 1941
by Glenn T. Seaborg and Margaret Melhase. Cesium-137 is a product of
fusion and is found in the fallout from the detonation of nuclear
weapons and the waste from nuclear power plants. Cesium-137 is one of
the most common radioisotopes used in industry. It is used in various
measuring devices, such as moisture-density gauges. Cesium-137 is also
widely used as a source of gamma radiation for treatment of various
forms of cancer. Cesium-137 has a half-life of 30.07 years.
Contamination with cesium-137 can cause serious illness or death,
depending upon the dose, and has been associated with the development
of cancer long after exposure. In addition to concerns about exposure
to cesium-137 in industrial and medical environments, cesium-137
contamination is of particular concern because it has been mentioned as
a potential component of a radiological dispersal device (RDD),
commonly called a ``dirty bomb.'' An RDD is a conventional explosive or
bomb containing radioactive material. The conventional bomb is used as
a means to spread radioactive material, such as cesium-137. An RDD is
not a nuclear bomb and does not involve a nuclear explosion.
B. Thallium
Thallium occurs naturally in several minerals and ores. It was
discovered independently by both William Crookes and Claude Auguste
Lamy in the early 1860s. Thallium is very toxic, and thallium sulfate
has been used as a rat and ant poison in the past. Other thallium
compounds are used in the manufacture of semiconductors, photocells,
optical glass, and other items. Thallium-201, a radioactive isotope of
thallium, is widely used in very small doses as an approved
radioimaging drug. Thallium-201 has a half-life of 72.912 hours.
Acute exposure to high dose radioactive or nonradioactive thallium
is generally characterized by severe gastrointestinal symptoms followed
by neurological symptoms, which may lead to death. The toxicity
resulting from chronic exposure to thallium is characterized by various
neurological symptoms. Thallium-201 has also been mentioned as a
potential component of a dirty bomb.
There are no approved treatments for internal contamination with
thallium or radioactive cesium.
C. Prussian Blue
Prussian blue was first synthesized in 1704 by a Berlin color maker
named Diesbach. It has been used as an industrial and artists' pigment
ever since. The chemical name for prussian blue is ferric
hexacyanoferrate(II).
The rest can be found at
<http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-2597.htm>
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