Ca/Zn-DTPA Cleared by FDA

[Carol Marcus <csmarcus@ucla.edu>]

Dear Radsafers:



The Food and Drug Administration today published in the Federal Register 

that Ca-DTPA and Zn-DTPA were safe and effective for the decorporation of 

plutonium, americium, and curium if made appropriately by a 

manufacturer.  At present, no manufacturer has been approved to do so in 

the United States.  FDA made this determination in the interest of homeland 

security after reviewing data on 646 patients treated with these drugs over 

40 years, based on the DOE REAC/TS IND.  (No one could accuse FDA of 

jumping to conclusions................!)



The citation is Fed. Reg. vol. 68 no. 178, Sept 13, 2003, pp 

53984-53989.  The url for the Federal Register is 

http://www.access.gpo.gov/su_docs/fedreg/frcont03.html.



The Los Angeles County Department of Health Services, Sacramento County, 

and the State of Israel, among some others, I believe, have purchased these 

drugs from a compounding pharmacy (Customcare) in Florida.  This pharmacy 

has also compiled a kit of various decorporation drugs, composed of 

FDA-approved drugs (but for unapproved decorporation uses), and Prussian 

blue, Ca-DPTA, and Zn-DTPA (declared "safe and effective" for decorporation 

uses but lacking an approved manufacturer), along with plasticized 

administration instruction sheets for doctors and nurses.



E-mail Dr. John Kuperus at <jkuperus@custompharmacy.com> or telephone at 

(813)882-4500/4363 for details if you are doing emergency response planning.



(I have no financial interest in this!)



Ciao, Carol



Carol S. Marcus, Ph.D., M.D.

<csmarcus@ucla.edu>



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