CVM Moves to Rescind Phibro Animal’s Carbadox

CVM has begun an approval rescission action against Phibro Animal Health’s carbadox and its use in treating swine because the drug may leave trace amounts of a carcinogenic residue. The Center’s move comes after it recently reexamined the drug’s safety profile 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. FDA-approved alternative antibiotics are available to treat swine, the agency says.

“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,” an agency release says. “As a result, FDA’s Center for Veterinary Medicine is taking legal action to remove this product from the marketplace.”