FDA Issues Final Rule on Cephalosporin Drugs
January 6, 2012
The Food and Drug Administration (FDA) plans to restrict a family of antibiotics commonly used to treat livestock, citing concerns that overuse might promote the development of drug-resistant bacteria that can infect people.
In today's Federal Register, the FDA said it would limit the use of cephalosporin in cattle, swine, chicken and turkey. The antibiotics can no longer be used to prevent diseases in livestock starting April 5, though they can still be used to treat illnesses, the FDA said.
A proposed order was published in 2008 prohibiting the extra-label use of cephalosporin drugs in food-producing animals, citing cephalosporin resistance in human medicine as risk to public health.
The American Sheep Industry Association (ASI) registered comments in 2008 on this order stating, "We believe that the extra-label use of the cephalosporin class of products in sheep would have a diminutive effect on any antimicrobial resistance in humans. We also believe that allowing the extra-label use of cephalosporins in sheep will reduce the pain, suffering and mortality in sheep from disease conditions for which there are no other available effective products."
In its Final Rule, the FDA agreed with ASI and several others who commented similarly by stating, "When considering the foodborne pathway, the potential for human exposure to antimicrobial-resistant pathogens is significantly less for food derived from minor species than it is for food derived from the food-producing major species. In addition, cephalosporins are approved for use in sheep and goats, thereby, reducing the potential for extra label use in these species."
As stated in ASI's 2008 comments, "Naxcel (ceftiofur sodium), for example, has a very limited label approval for the treatment of respiratory disease by intramuscular injection only in sheep. A prohibition on this drug would leave the U.S. sheep industry with nearly no tools to treat gram-negative bacterial infections."
According to ASI President Margaret Soulen Hinson, "The U.S. sheep industry believes in and practices the judicious and responsible use of the few anti-microbial drugs available to us for the treatment of sheep diseases and we appreciate FDA's revisions to the final rule on this matter."