FDA Moves To Prohibit Extra-label Uses Of Cephalosporin

FDA Moves To Prohibit Extra-label Uses Of Cephalosporin

Ruling may impact certain antimicrobial drug use in cattle, swine and poultry effective April 5. Comment period still open.

The U.S. Food and Drug administration is clamping down on use of the cephalosporin class of antimicrobial drugs in food-producing animals. Effective April 5 of this year, extra-label use of the products will be prohibited in cattle, swine, chickens and turkeys effective April 5, 2012.

Antimicrobial drugs are important for treating disease in both humans and animals. This new order takes into consideration the substantial public comment FDA received on a similar order that it issued in 2008, but revoked prior to implementation.

FDA is taking this action to preserve the effectiveness of cephalosporin drugs for treating disease in humans. They are commonly used to treat pneumonia plus skin and soft tissue infections. In addition, they are used in the treatment of pelvic inflammatory disease, diabetic foot infections, and urinary tract infections.

Extra-label or unapproved uses prohibited include:

Unapproved dose levels, frequencies, durations, or routes of administration;

Uses for non-approved treatments in cattle, swine, or poultry; and

Uses for disease prevention.

The order doesn't limit use of cephapirin, an older cephalosporin drug not believed by FDA to contribute significantly to antimicrobial resistance. Veterinarians will still be able to use or prescribe cephalosporin for limited extra-label use as long as they follow the labeled dose, frequency, duration and route of administration. 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," says Michael Taylor, Deputy FDA Commissioner for Foods.

The new order of prohibition has a comment period that closes on March 6. To comment on the order, visit www.regulations.gov  and enter FDA-2008-N-0326 in the keyword box. FDA will again consider the comments before the prohibition takes effect.
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