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Article: U.S. FDA OKs drugs to counter radiation attack



Colleagues:



See http://www.alertnet.org/thenews/newsdesk/N11442422.htm 



Jim Hardeman

Jim_Hardeman@dnr.state.ga.us 



=================



U.S. FDA OKs drugs to counter radiation attack

11 Aug 2004 19:59:40 GMT

 

WASHINGTON, Aug 11 (Reuters) - The U.S. Food and Drug Administration on Wednesday approved two drugs to treat people who are exposed to plutonium or two other types of radioactive materials that could be used in a terror attack, opening the way for mass distribution of the drugs.



The FDA's action means the injectable drugs, which also treat americium or curium contamination, would be available by prescription -- presumably for anyone who wanted them even before an attack took place, agency officials said.



"The approval of these two drugs is another example of FDA's readiness and commitment to protecting Americans against all terrorist threats," said Acting FDA Commissioner Lester Crawford.



Both drugs -- penetrate calcium trisodium injection (Ca-DTPA) and penetrate zinc trisodium injection (Zn-DTPA) -- have been available for decades for use in contamination emergencies, the FDA said.



The FDA considered the two drugs, made by Germany's Hameln Pharmaceuticals GmBH, investigational prior to the approval, which limited the amount available.



In September 2003 the agency announced the medicines could safely decontaminate patients with certain kinds of radiation exposure and encouraged companies to step forward to make them.



Wednesday's approval provides for that manufacturer. It could also help make the drug easier to get by allowing the government to stockpile it or for a patient to get it through a prescription -- even before the contamination occurred, FDA officials said.



The FDA said the decision was part of the agency's efforts to encourage the development of treatments in case of an attack.



If absorbed by the body certain radioactive particles can cause cancer, bone tumors and other severe problems, even years after exposure.



Radiation contamination could occur from industrial accidents or terror attacks through so-called "dirty bombs." People could absorb radioactive particles by ingestion, breathing or through open wounds, the agency said.



Plutonium is a by-product of reactors at nuclear power plants. Americium, a man-made radioactive metal, is often used commercially for a number of devices, including medical diagnostics. Curium, another synthetic, also results from nuclear reactors. 







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