FDA Prohibits Extralabel Use of Cephalosporins

January 4, 2012 09:45 AM

Impact on producers, veterinarians likely to be minor

The U.S. Food and Drug Administration (FDA) issued an order in early January that prohibits the
extra-label use of cephalosporin drugs in livestock, including dairy cattle, at unapproved dose levels, frequencies or routes of administration.

FDA says it is taking the action to preserve the effectiveness of cephalosporin drugs for treating diseases in humans. Prohibiting extra-label use in livestock species reduces the risk of cephalosporin resistance in certain bacterial pathogens, the agency says.

In addition, FDA prohibits using cephalosporin drugs in cattle, swine, chickens or turkeys that are not approved for use in those species.

It also prohibits use of the drug for disease prevention.

"We believe this is an imperative step in preserving the effectiveness of this class of important anti-microbials that takes into account the need to protect the health of both humans and animals," says Michael Taylor, FDA’s deputy commissioner for foods.

Pfizer’s response: "Pfizer Animal Health strongly supports the responsible use of all antibiotics to protect animal and human health and strongly advocates veterinary involvement whenever antibiotics are used."

The move was heralded in consumer media as a way to protect the drugs’ effectiveness in human medicine. But veterinarians say they will still be able to use cephalosporins effectively based on labeled uses.

"The FDA’s proposed order does not affect FDA’s approved indications for ceftiofur [Excede, Excenel RTU, Naxcel, Spectramast LC and Spectramast DC]," says Christina Lood, Pfizer spokesperson. "The veterinarian’s ability to prescribe cefitofur for FDA-approved uses in food animals is unchanged."

The order also does not limit the use of cephapirin, an older cephalosporin drug that FDA believes does not contribute significantly to antimicrobial resistance.

Veterinarians will be allowed to prescribe cephapirin for limited extra-label use in livestock as long as they follow the dose, frequency, duration and route of administration specified on the label.

The new order has a comment period under way that will end on March 6, 2012.

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