Phibro Animal Health Corp. is defending the safety of its swine drug Mecadox (carbadox) after the U.S. Food and Drug Administration moved to rescind approval of the antimicrobial because of the potential risk to people who eat carbadox-treated pigs.
Approved in the 1970s, Mecadox is indicated for the control of salmonella and swine dysentery and for weight gain and feed efficiency. The Mecadox label requires pigs to be off the drug for at least 42 days before slaughter.
The FDA Center for Veterinary Medicine on Friday announced that a safety re-examination found the medication may leave trace amounts of a carcinogenic residue.
“A preliminary risk characterization … indicated there could be potential risk to human health from ingesting pork, especially pork liver, derived from carbadox-treated pigs,” the agency stated.
Phibro, based in Teaneck, N.J., noted that FDA’s action does not prohibit the sale or use of Mecadox.
The company criticized the agency’s action as hasty given that Phibro is close to completing further studies of carbadox.
“Our studies are due to be completed in the next 90 days, and we expect that the remaining evidence will support the continued safe use of Mecadox,” Phibro stated.
“We are disappointed that the FDA would take this action when definitive studies are so close to being completed.”
Given 30 days to request a formal hearing, the company stated that it would do so and that it intends to “refute the allegations.”
Consumers do not need to change their pork eating habits, according to FDA.
“Potential cancer risks are based on an assumed lifetime of consuming pork liver or other pork products containing carbadox residues, and short-term changes in diet are unlikely to affect a person’s lifetime risk,” the agency reported.
Pork liver is used in liverwurst, hot dogs, lunch meat and some sausages, FDA noted.