FDA recinds approval of Phibro pig drug due to human cancer worry


The FDA is taking steps to rescind its approval of carbadox, an antibiotic used to treat swine, the agency announced April 8. The problem? After re-examining the drug's safety data, the FDA has determined that pork derived from carbadox-treated pigs may have trace amounts of carcinogenic residue.

Phibro has not provided sufficient data to demonstrate that it's safe for people to eat meat from animals treated with carbadox, according to a press release from the FDA. The agency is particularly concerned about pork liver, the main ingredient in liverwurst, hot dogs, lunchmeat and some sausages.

"Pork is a good source of protein," the FDA said in a statement provided to Reuters. "However, protein can also be found in other meat, poultry, seafood, beans and peas, eggs, processed soy products, nuts and seeds." The agency noted in its statement that there are alternatives to carbadox and that it would work with pork producers to minimize the impact of the withdrawal.

Carbadox was approved in the 1970s to control dysentery and bacterial enteritis in pigs, the FDA says, but it has also been used to fatten up animals and improve feed efficiency--uses that are now frowned upon because of concerns about antibiotics resistance. Concerns about a link between the product and cancer were raised in 2014 by a report from the Food and Agriculture Organization of the United Nations and the World Health Organization Codex Committee on Residues of Veterinary Drugs in Foods, according to the FDA.

Phibro, which is based in New Jersey, has 30 days to request a hearing to discuss the FDA's plan to withdraw carbadox from the market. As of midday on April 8, the company had not released a statement regarding the FDA's plan.

But the market shift away from antibiotics had already been a burden for Phibro. Even though the company's sales in its second fiscal quarter rose 2%, its performance missed analysts' expectations. The company acknowledged it was hurt by a $1.8 million year-over-year decline in sales of medicated feed additives, including antibiotics. Phibro has been increasing its efforts in vaccine development to make up for the declining antibiotics business.

- here's the FDA's press release
- read more at Reuters