FDA Bans "Extra-Label" Uses Of Popular Class Of Antibiotics On Farm Animals

For those of you who are concerned about the amount of antibiotics being given to the cows, chickens, pigs and turkeys that provide (or end up as) the food on your plate, here’s some good news. The Food and Drug Administration has announced a new regulation that prohibits “extra-label” uses of a popular class of antibiotics.

Effective April 5, 2012, the cephalosporin class of antibiotics (which are commonly used to treat pneumonia and urinary tract infections, among other maladies, and includes such family favorites as Cefalexin) can no longer:
*use cephalosporin drugs at unapproved dose levels, frequencies, durations, or routes of administration;
*use 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);
*use cephalosporin drugs for disease prevention.

“FDA is taking this action to preserve the effectiveness of cephalosporin drugs for treating disease in humans,” explains the agency. “Prohibiting these uses is intended to reduce the risk of cephalosporin resistance in certain bacterial pathogens.”

There are some exceptions to the new regulations:
*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, swine, chickens or turkeys as long as they follow the dose, frequency, duration, and route of administration that is 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 R. Taylor, FDA Deputy Commissioner for Foods.

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