WEDNESDAY, June 8 (HealthDay News) -- A drug maker has agreed to
suspend the sale of its animal drug 3-Nitro from the market because
it contains organic arsenic that can be transformed into inorganic
arsenic, a known carcinogen, the U.S. Food and Drug Administration
(FDA) said Wednesday.
The drug, also known as Roxarsone, was approved by the FDA in
1944 and has been used in broiler chickens to control coccidiosis
-- a disease that affects the intestinal tracts of animals -- and
to speed weight gain, feed efficiency and improve color of the
"The levels of inorganic arsenic found in chicken livers are very low and represent a very low health risk to people who eat chicken," Dr. Bernadette Dunham, director of FDA's Center for Veterinary Medicine, said during an afternoon press conference.
"Consumers can continue to eat chicken as 3-Nitro is suspended from the market," she said. "Furthermore, FDA does not believe there is a need to recall chicken already in commerce."
The Alpharma division of Pfizer Inc. voluntarily suspended
3-Nitro after testing of 100 chickens found higher levels of
arsenic in chickens given 3-Nitro than in birds that did not
receive the drug.
The FDA pointed out that organic arsenic occurs naturally in the
environment and is commonly found in water, air, soil and food.
However, over the last eight years, studies have found that the
less toxic form of arsenic -- organic arsenic, which is commonly
found in 3-Nitro -- can become the more toxic inorganic arsenic,
the FDA said. And it is this form of arsenic that researchers found
in the livers of chickens treated with 3-Nitro.
Although 3-Nitro was approved in 1944, over the years there have
been several other FDA reviews and approvals of the drug. The
latest was in 2009, according to the agency.
At the time 3-Nitro was approved it was assumed that the organic
arsenic in 3-Nitro would be excreted as organic arsenic, which is
not known to cause cancer.
"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
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
For more information on 3-Nitro, visit the
U.S. Food and Drug Administration.
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