"Until recently, scientific evidence indicated that animals exposed to organic arsenic rapidly excrete the compound in its original form -- as organic arsenic. FDA approved the product at doses and withdrawal times that, based on this available information, allowed for the safe and effective use of the product when used according to the label directions," the agency said.
According to the FDA, Alpharma will continue selling 3-Nitro for the next month, which the company says will allow time for chicken farmers to find alternate ways of protecting their animals from coccidiosis.
With the suspension of 3-Nitro only one approved animal drug containing arsenic remains on the market, called Nitarsone, also made by Alpharma. This drug is also used in chickens and turkeys. The FDA has little information on this drug, but is now looking into it, Dr. Bill Flynn, deputy director for science policy at FDA's Center for Veterinary Medicine, said during the press conference.
More information
For more information on 3-Nitro, visit the U.S. Food and Drug Administration.
SOURCES: June 8, 2011, teleconference with: Bernadette Dunham, D.V.M., Ph.D., director, Center for Veterinary Medicine, Bill Flynn, D.V.M., M.S., deputy director for science policy, Center for Veterinary Medicine, both of the U.S. Food and Drug Administration
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