FDA Acts to Limit an Antibiotic in Livestock
05 Jan, 2012
The Food and Drug Administration announced Wednesday [January 5, 2012] that it will be restricting the use of cephalosporin—a type of antibiotic—in food animals in order to prevent the growth of antibiotic-resistant strains of human diseases.
The cephalosporin class of drugs is used to treat a variety of serious conditions, including skin infections, urinary tract infections, pneumonia, abdominal infections, bone infections, pelvic inflammatory disease and meningitis.
Of all drugs prescribed to outpatients, 14 percent are from the cephalosporin class.
“Newer cephalosporins are used in the hospital setting to treat seriously ill patients with life-threatening disease,” according to FDA.
Mounting scientific evidence has shown that the overuse of cephalosporin in food animals is contributing to the development of drug-resistant strains of these bacteria.
“If cephalosporins are not effective in treating these diseases,” said FDA in a statement Wednesday, “doctors may have to use drugs that are not as effective or that have greater side effects.”
Two foodborne illnesses – Salmonella and Shigella infections – are commonly treated with these drugs. It is via these bacteria that cephalosporin resistance is thought to be transmitted from animals to humans.
“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,” reads the FDA rule.
Properties of resistance can then transmitted from one bacteria to another.
“What the science is telling us is that these bacteria all communicate and share information with each other and they pass along these resistance genes, and that’s a really troubling thing,” said Laura Rogers of Pew Charitable trusts, a public policy watchdog. Rogers is project director for the organization’s Campaign on Human Health and Industrial Farming.
And once bacteria develop resistant to one type of cephalosporin, it can become resistant to others.
“Resistance to certain cephalosporins is of particular public health concern in light of the evidence of cross-resistance among drugs in the cephalosporin class,” FDA explains in its rule.
The agency is not forbidding the use of these drugs in animals outright, but is eliminating “extra-label” or “off-label” use, unapproved uses that may contribute to antibiotic resistance.
The newly prohibited uses include:
- Using cephalosporins 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. ones intended for human or companion animals)
- Using cephalosporins for disease prevention
However, cephalosporins will still be permitted for use in the following scenarios:
- Cephaprin, an older drug of this class not believed to contribute significantly to antiobiotic resistance
- Veterinarians can still prescribe cephalosporins for limited extra-label use in cattle, swine, chickens and turkeys
- Cephalosporins may still be prescribed for minor species of food-producing animals such as ducks or rabbits
These exceptions to the prohibition of extra-label uses are new to FDA’s proposed rule on cephalosporins. The agency issued an earlier version of this rule in June of 2008, but withdrew it after it met with criticism because it outlawed uses of the drug that did not lead to antimicrobial resistance.
FA’s new order, scheduled to go into effect in April, follows a notice published in the Federal Register just before the holidays that indicated the agency was backing away from a 1977 announcement that it had decided not to withdraw penicillin and tetracyclines in animal feed.
The agency said it was planning to ‘focus its efforts for now on the potential for voluntary reform and the promotion of the judicious use of antimicrobials in the interest of public health.”
In November, to the dismay of consumer and sustainable agriculture advocates, the FDA rejected two petitions to ban certain antibiotics from being used in food animal production. It said it was “currently pursuing other alternatives to address the issue of antimicrobial resistance related to the production use of antimicrobials in animal agriculture.”
But in announcing the new order Wednesday, Dr. Michael Taylor, the FDA’s commissioner of foods, said, “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.”