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Re: Ca/Zn-DTPA Cleared by FDA
At 05:40 PM 9/15/2003 -0700, Carol Marcus wrote:
>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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Dear Radsafers:
Sorry for the typo. The correct Federal Register date is Sept. 15th, not 13th.
Ciao, Carol
Carol S. Marcus, Ph.D., M.D.
<csmarcus@ucla.edu>
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