October 21, 2016

FDA Rescinds Approval of Carbadox to Treat Swine

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is starting the process of rescinding approval of the use of carbadox, an antibiotic, to treat swine because it may leave trace amounts of a carcinogen in the meat. The agency recently reexamined the safety profile of the drug and concluded that there could be “potential risk to human health from ingesting pork, especially pork liver, derived from carbadox-treated pigs.”

Pig in StallMichael R. Taylor, FDA deputy commissioner for foods and veterinary medicine said in a statement, “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. As a result, FDA’s Center for Veterinary Medicine is taking legal action to remove this product from the marketplace.”

The FDA is not recommending that anyone stop eating pork because of this finding. The potential cancer risks are based on an assume lifetime of consuming pork liver or other pork products containing residues of this drug. Short term changes in the diet are “unlikely to affect a person’s lifetime risk,” according to the agency. Pork liver is used to make liverwurst, hot dogs, lunchmeat, and some types of sausage. The FDA states that eating a varied diet may reduce the potential negative effects of eating too much of any one particular food.

Carbadox was approved for use in the early 1970s to control swine dysentery and bacterial swine enteritis. It is also used for weight gain and feed efficiency. The Codex Alimentarius Commission determined in July 2014 that there is no safe level of residues of carbadox or its metabolites in food that represents an acceptable risk to consumers.

CVM filed a Notice of Opportunity for Hearing on April 8, 2016. The company that produces carbadox has 30 days to request a hearing. The manufacturer of all of the drug applications for carbadox is Phibro Animal Health of Teaneck, New Jersey. If the company does not request a hearing, CVM will proceed removing the drug from the market.

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