Silver Spring, Md.
— Alpharma, a Pfizer subsidiary, will voluntarily suspend sales of 3-Nitro (Roxarsone), a drug that has been in the company’s portfolio since 1944 and is primarily used in broiler chickens.
3-Nitro is an arsenic feed additive that improves weight gain and feed efficiency in poultry and swine, according to Alpharma. It also has been effective in aiding the treatment of swine dysentery and preventing coccidiosis in poultry when used with certain anticoccidials.
Alpharma’s decision to suspend sales comes on the heels of a recent study of 100 broiler chickens by the U.S. Food and Drug Administration that found inorganic arsenic, a carcinogen, at higher levels in the livers of those chickens treated with 3-Nitro compared to those that were untreated. The levels of inorganic arsenic were very low, notes FDA, adding that chickens already treated with the drug do not pose health risks in regard to human consumption.
“FDA detected increased levels of inorganic arsenic in the livers of chickens treated with 3-Nitro, raising concerns of a very low but completely avoidable exposure to a carcinogen,” says Michael R. Taylor, FDA deputy commissioner for foods. “We are pleased to announce that the company is cooperating with us to protect the public health.”
FDA says “Alpharma decided to voluntarily suspend sale of 3-Nitro and to facilitate an orderly process for suspending use of the product in the United States. Alpharma’s plan provides for continued sales of 3-Nitro for 30 days from today.”
Alpharma also is working with FDA to examine all data about the use of 3-Nitro in animals, the regulator says. FDA says it is working with the U.S. Department of Agriculture and Alpharma to minimize the impact of the move on the animal agriculture industry.
The full FDA study on 3-Nitro (Roxarsone) can be found here.