FDA Acts to Limit an Antibiotic in Livestock

“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.”

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