Antibiotic issues are back in the spotlight as the New Year gets underway. .The U.S. Food and Drug Administration has issued an order that will prohibit certain uses of the cephalosporin class of antimicrobial drugs in cattle, swine, chickens and turkeys. The order will go into effect April 5, 2012.
According to agency officials, FDA is taking this action to preserve the effectiveness of cephalosporin drugs for human use. Cephalosporins are commonly used in humans to treat pneumonia as well as to treat skin and soft tissue infections. In addition, they are used in the treatment of pelvic inflammatory disease, diabetic foot infections and urinary tract infections.
"What happened yesterday is that FDA said cephalosporins are an importnat drug and we want to regulate some of those uses," says Liz Wagstrom, DVM, the National Pork Producers Council's chief veterinarian.
FDA’s order focuses on “extra-label” or uses that are not designated on the label specific to cattle, swine, chickens and turkeys."What that means for pork producers is they can use cephalosporins, but they have to use it at the dosage and in the manner that's designated on the label," Wagstrom notes. For example, if a specific drug product is designated to be administered as an injectable, it cannot be given in the water.
"They (producers) are allowed to use these (cephalosporin) drugs to treat sick animals and for sick animals with diseases that may not be on the label," she adds.
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 (for example, cephalosporin drugs intended for humans or companion animals);
- Using cephalosporin drugs for disease prevention.
In 2008, FDA issued and then revoked an order that prohibited, with no exceptions, extra-label uses of cephalosporins. FDA officials say that this latest action responds to public comment and includes the following exceptions, which protect public health while considering animal health needs:
- The order does not limit the use of cephapirin, an older cephalosporin drug that FDA does not believe contributes significantly to antimicrobial resistance.
- Veterinarians will still be able to use or prescribe cephalosporins for limited extra-label use in cattle, swine, chickens or turkeys as long as they follow the dose, frequency, duration and administration route cited on the label.
- Veterinarians may also use or prescribe cephalosporins for extra-label uses in minor species of food-producing animals such as ducks or rabbits.
"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 Taylor, FDA deputy commissioner for foods.
A public comment period on the new order will run from Jan. 6 to Mar. 6, 2012. A link to comment on the new order is available here. Once there, enter FDA-2008-N-0326 in the keyword box.
Following that period, FDA will review and consider the comments received prior to implementing the order on April 5.