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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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