by Richard L. Lobb on Jan. 4, 2012

from www.meatingplace.com — reprinted by permission

The Food and Drug Administration is moving to ban many extra-label uses of cephalosporin drugs in cattle, swine, chickens, and turkeys, saying the drugs may cause failure of antibiotic treatment of life-threatening infections in humans.  The industry says 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.  “We question any substantive link or scientific basis between veterinary use of cephalosporins and antibiotic resistance in humans.”

FDA announced Wednesday that it will publish a notice in Friday’s Federal Register prohibiting the use of cephalosporin drugs in food animals for disease prevention purposes.  The agency said it would also restrict other uses of the drugs to the doses, frequencies, duration, or routes of administration that are already approved, and also to the species and production classes already approved.

The news release and a link to the Federal Register notice can be found at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm285704.htm?source=govdelivery

“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, FDA deputy commissioner for foods.

Cephalosporins are used to treat bacterial pneumonia in pigs and cattle and to control early mortality in chicks and turkey poults.  Ceftiofur is a widely used cephalosporin sold under the brand named Naxcel.

FDA singled out the use of ceftiofur in dairy cattle as a concern, saying dairy farmers often fail to keep required records.  The agency also noted that ceftiofur is supposed to be given to chicks and poults after they hatch, but in fact is usually administered while the animal is still in the egg with the Inovoject system.  Injection is not an approved “route of administration,” the agency said.

The agency said the new restrictions would, among other things, ban “Biobullets.”  The agency said this is a pellet of ceftiofur sodium encased in a biodegradable bullet that is fired by an air rifle into the muscle of cattle.

The new restrictions do not apply to a drug cephapirin, the agency said, because it has a limited market.

The notice signed by Bernadette Dunham, director of FDA’s Center for Veterinary Medicine, said the agency would accept comments on its final rule until March 6 and consider them before the rule goes into effect on April 5.  FDA first proposed the restrictions in 2008 but withdrew them after a storm of criticism from veterinarians and members of the industry.  The new rule is more limited than the one proposed in 2008, the notice said.

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 extralabel use of cephalosporins in certain food-producing animal species is contributing to the emergence of cephalosporin-resistant zoonotic foodborne bacteria,” FDA said.

FDA said it was particularly worried because resistance to ceftiofur compromises the effectiveness of a related drug called ceftriaxone, which is said is a “first-line therapy for treating salmonellosis in humans.”  Drugs in cephalosporin class are also used to treat pneumonia and staph infections of the skin in humans, the agency said.

“The Agency considers the most significant risk to the public health associated with antimicrobial resistance to be human exposure to food containing antimicrobial-resistant bacteria resulting from the exposure of food-producing animals to antimicrobials, including cephalosporins,” FDA said.

Ron Phillips, vice president for public and legislative affairs at Animal Health Institute, said NARMS data are 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.