April 11, 2016

US FDA rejected carbadox animal drug over long term risk of cancer

The US Food and Drug Administration (FDA) has rejected a drug that treats particular conditions in pigs due to suspected cancerous effects it might have on human health.

Previously approved in 1972, the drug, carbadox, is manufactured by Phibro Animal Health and controls swine dysentery and bacteria enteritis as well as supporting weight gain.

The agency warned of possible cancer risks if pork products with carbadox residues are consumed over a lifetime. It is currently working to have the drug withdrawn from sales.

Phibro has also been requested by the FDA for additional information concerning the safety of carbadox. It has yet to submit proof that the drug is safe for use.

Carbadox is found in three Phibro antibiotics, namely, Mecadox Premix 10, Banminth/Mecadox and Mecadox/Terramycin.

The company could request for a hearing on the matter within 30 days. Failing which, approvals of carbadox will be void and the drug will no longer legal in the US.

The latest development came after a preliminary risk assessment from 2012 to 2014 discovered that consuming pork liver with traces of carbadox residue escalates lifetime cancer risk beyond the permitted levels of the FDA's framework for carcinogenic animal drugs.   

- Reuters