WASHINGTON — The U.S. Food and Drug Administration announced June 8 that Alpharma, a subsidiary of Pfizer Inc., will voluntarily suspend U.S. sales of the animal drug 3-Nitro (Roxarsone), a product used by poultry producers since the 1940s.
The move follows a recent FDA study of 100 broiler chickens that detected inorganic arsenic, a known carcinogen, at higher levels in the livers of chickens treated with 3-Nitro compared with untreated chickens.
No health risk
FDA officials stress that the levels of inorganic arsenic detected were very low and that continuing to eat chicken as 3-Nitro is suspended from the market does not pose a health risk.
“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,” said Michael R. Taylor, FDA deputy commissioner for foods.
Arsenic is in the environment as a naturally occurring substance or as a contaminant and is found in water, air, soil, and food.
Published scientific reports have indicated that organic arsenic, a less toxic form of arsenic and the form present in 3-Nitro could transform into inorganic arsenic.
Scientists from the FDA’s Center for Veterinary Medicine and the Center for Food Safety and Applied Nutrition found that the levels of inorganic arsenic in the livers of chickens treated with 3-Nitro were increased relative to levels in the livers of the untreated control chickens.
Alpharma decided to voluntarily suspend sale of 3-Nitro, although the plan provides for continued sales of 3-Nitro for 30 days from June 8.
About the product
In 1944, 3-Nitro became the first arsenic-containing new animal drug product approved by the FDA. It is used primarily in broiler chickens.
Combined with other animal drugs, 3-Nitro has been used by some in the poultry industry to help control coccidiosis, a parasitic disease that affects the intestinal tracts of animals. It has also been used for weight gain, feed efficiency and improved pigmentation.
Poultry producers with questions should contact Pfizer Veterinary Medical Information Product and Support, 800-366-5288.