The United States Food and Drug Administration says it will restrict the use of the Cephalosporin class of antimicrobial drugs in cattle, pigs, chickens and turkeys from April 5 this year, saying it believes extralbel use of the antibiotic could cause failure of antibiotic treatment of life-threatening infections in humans. 

Cephalosporins are commonly used in humans to treat pneumonia as well as to treat skin and soft tissue infections, the FDA said. In addition, they were used in the treatment of pelvic inflammatory disease, diabetic foot infections, and urinary tract infections.

“If cephalosporins are not effective in treating these diseases, doctors may have to use drugs that are not as effective or that have greater side effects,” the FDA said.

In its order, FDA is prohibiting what are called “extra-label” or unapproved uses of cephalosporins in cattle, pigs, chickens and turkeys, the so-called major species of food-producing animals.

Specifically, the prohibited uses include:

• using cephalosporin drugs at unapproved dose levels, frequencies, durations, or routes of administration;
• using cephalosporin drugs in cattle, swine, chickens or turkeys that are not approved for use in that species (e.g., cephalosporin drugs intended for humans or companion animals);
• using cephalosporin drugs for disease prevention.

The order does not limit the use of Cephapirin, an older cephalosporin drug that is not believed by FDA to contribute significantly to antimicrobial resistance.

Veterinarians will still be able to use or prescribe cephalosporins for limited extra-label use in cattle, pigs, chickens or turkeys as long as they follow the dose, frequency, duration, and route of administration that is on the label.

"We believe this is an imperative step in preserving the effectiveness of this class of important antimicrobials that takes into account the need to protect the health of both humans and animals," said Michael R. Taylor, Deputy Commissioner for Foods.

The new order of prohibition has a comment period that will begin on Jan. 6, 2012 and close on March 6, 2012.

In response US meat industry representatives say the FDA has little evidence that a problem actually exists.

“Antibiotics are a valuable tool in ensuring animal health and in producing wholesome food for the consuming public,” said Tom Super, vice president communications of the National Chicken Council, told Meatingplace.com

“We question any substantive link or scientific basis between veterinary use of cephalosporins and antibiotic resistance in humans.”

Meatingplace.com said cephalosporins were used to treat bacterial pneumonia in pigs and cattle and to control early mortality in chicks and turkey poults.

FDA said it acted because of an upsurge of bacterial resistance to cephalosporins in samples taken from food animals in the National Antimicrobial Resistance Monitoring System (NARMS).

“In 1997, no Salmonella isolates from cattle or swine were resistant to ceftiofur, while ceftiofur resistance among isolates from chickens and turkeys was 0.5 percent and 3.7 percent, respectively,” the notice said.  “By 2009, the prevalence of ceftiofur resistance among Salmonella slaughter isolates increased to 14.5 percent for cattle, 4.2 percent for swine, 12.7 percent for chickens, and 12.4 percent for turkeys,” it added.

“It is likely that the extra label use of cephalosporins in certain food-producing animal species is contributing to the emergence of cephalosporin-resistant zoonotic foodborne bacteria,” FDA said.
Ron Phillips, vice president for public and legislative affairs at Animal Health Institute, told Meatingplace.com the NARMS data were not representative of all food-producing animals.

“The evidence is thin,” he said. “The rule on cephalosporins is the latest in a series of steps by FDA that have greatly tightened the use of antibiotics in animals,” he added.

A maker of antibiotic-free meat products, however, praised the move.

“The Food and Drug Administration did the right thing in limiting the use of cephalosporins in food animal production, and I urge them to keep moving forward so that we can save antibiotics and avert a public health crisis,” said Stephen McDonnell, founder and CEO of Applegate, which makes natural and organic meats and cheeses.

“Applegate is committed to educating the public about the dangers of antibiotic overuse in animal agriculture and its effects on the environment and human health,” added McDonnell, who in partnership with STOP Foodborne Illness launched Citizens Against Superbugs in December 2011.