WASHINGTON, April 8, 2016 – The Food and Drug Administration is moving to withdraw approval for the swine drug carbodox, citing the potential cancer risk to consumers.
The drug, manufactured by Phibro, is used to treat bacterial illness. The company “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 Taylor, FDA’s deputy commissioner for foods and veterinary medicine.
Phibro, which markets the drug as Mecadox, said it is confident in the safety of the product.“Mecadox is not used in human medicine and the class of drug is not considered a medically important antimicrobial,” the company said. “The approved Mecadox label requires a 42-day withdrawal period pre-harvesting, and to date we have not seen any hazardous residues of carbadox being detected from pig meat treated in accordance with the approved label.”
The company said it is using new technologies to test for residues in tissue longer than previously possible, and it expects the results of those studies to be available within 90 days. “We expect that the remaining evidence will support the continued safe use of Mecadox,” the company said.
Carbadox was originally approved in the early 1970s for treatment of swine dysentery and bacterial swine enteritis, but the FDA said it has also been used for weight gain and feed efficiency.
According to a 2012 report from the Department of Agriculture’s Animal and Plant Health Inspection Service, more than 40 percent of nurseries used carbadox in feed for 23 days, on average.
Under the approval withdrawal process, FDA must file a Notice of Opportunity Hearing, which it did Friday. The company then has 30 days to request a hearing over the drug’s withdrawal. Phibro has announced intentions to pursue a hearing and says it will continue to market and sell Mecadox for the time being.
A consumer advocacy group, Food Animal Concerns Trust, urged Phibro to accept the FDA’s decision. “Carbadox is a known carcinogen, so removing this drug from the food supply is a victory for public health,” the group said.
FDA said the cancer risk was based on an “assumed lifetime of consuming pork liver or other pork products containing carbadox residues.” Pork liver is used to make liverwurst, hot dogs, lunchmeat and some types of sausage.
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