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FDA to revoke pig drug carbadox approval over human cancer risk concern (2016-04-21)


The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) took the first step toward rescinding its approval of the use of carbadox to treat swine because the drug may leave trace amounts of a carcinogenic residue.

CVM’s action comes after the center recently reexamined the safety profile of the drug and conducted a preliminary risk characterization that indicated there could be potential risk to human health from ingesting pork, especially pork liver, derived from carbadox-treated pigs.
Pork liver is used to make liverwurst, hot dogs, lunch meat and some types of sausage, the agency said.

“The manufacturer of carbadox has failed to provide sufficient scientific data to demonstrate the safety of this drug given evidence that carbadox may result in carcinogenic residues,” said Michael R. Taylor, FDA deputy commissioner for foods and veterinary medicine. “As a result, FDA’s Center for Veterinary Medicine is taking legal action to remove this product from the marketplace.”

Carbadox was first approved in the early 1970s for use in swine to control swine dysentery and bacterial swine enteritis. It has also been used for weight gain and feed efficiency.

In July 2014, the Codex Alimentarius Commission determined there is no safe level of residues of carbadox or its metabolites in food that represents an acceptable risk to consumers.
This was based on the Food and Agriculture Organization of the United Nations/World Health Organization Codex Committee on Residues of Veterinary Drugs in Foods’ conclusions on the available scientific information.

Pork producers have become more interested in carbadox recently because it does not require a veterinarian's prescription, according to John Goihl, president of Agri-Nutrition Services Inc, a Minnesota-based firm that provides feed formulations and consulting services to manufacturers and livestock producers.

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FDA - U.S. Food and Drug Administration