Cephalosporins in beef production: What are the implications of new rules?

Feb 3, 2012
by WLJ

The Food and Drug Administration’s (FDA) new rules tightening the use of cephalosporins in food animals may end up affecting how cattle veterinarians, cow/calf producers and cattle feeders use these drugs to treat illness in their animals.

Cephalosporins are a family of drugs that are used in both people and animals. The cephalosporins most beef producers are familiar with are the injectable ceftiofur products Naxcel (and its generic equivalents), Excede and Excenel. Cephapirin is a cephalosporin used in mastitis preparations for dairy cattle, but it has been exempted from the new rules.

Because of their close relation to drugs used in people, the FDA has sought to clamp down on the uses of these drugs in animals. In 2008, FDA proposed rules that would mean these drugs could only be used strictly according to their labels, even by veterinarians. The current proposed rules are less restrictive to veterinarians and producers than those proposed back then.

One major effect of the new rules would be to end the use of cephalosporin drugs that are not approved for use in a certain species. For example, veterinarians by law have been able to use human-labeled antibiotics to treat sick animals when no labeled food animal drug is available. This has been more of an issue in swine medicine, but a veterinarian who once was able to treat a calf with a cephalosporin drug approved for dogs, for example, would no longer be able to do this.

Extra-label use of the approved injectable drugs is still allowable, under a valid Veterinary Client Patient Relationship (VCPR), as always, but with certain limits. These drugs may still be used to treat conditions in calves, cows or bulls not listed on the label. For example, under a VCPR, a veterinarian or producer could still use these drugs to treat a salmonella infection in a calf, despite that not being listed on the label.

What will not be allowed anymore, however, is to use a higher or more frequent dose, or to give the drug by a route of administration that is not spelled out on the label (like IV injection of a preparation labeled for intramuscular use). In short, veterinarians and producers with a VCPR can still use these drugs for conditions not listed on the label, but the dose, route, and frequency listed on the label need to be adhered to. These injectable products, as before, are only available through a prescription from a veterinarian.

In addition, the new rules prohibit use of cephalosporin drugs to prevent disease. The question arises about the use of these drugs for metaphylaxis. Metaphylaxis refers to the practice of treating a group of high-risk cattle upon arrival at a feedlot with full doses of an injectable antibiotic as a means of treating animals already showing signs of illness, along with those who are subclinically affected. Whether this practice will still be allowable with cephalosporin drugs is still the subject of some discussion. In general, since these prod- ucts are labeled for “control,” it’s possible that metaphy- lactic use for bovine respira- tory disease will still be al- lowable. Ca Cattle producers should, however, how discuss the ramifications ifi ti of these potential new regulations with their veterinarians.

According to Roger Saltman, Pfizer Animal Health’s group director for veterinary operations, the order:

- allows for continued extra label prescribing of cephalosporin drugs in cattle, swine, chickens and turkeys via approved routes of administration and dose for the treatment and control of disease.

- prohibits the use of cephalosporin drugs at unapproved doses, frequencies, durations, or routes of administration.

- does not affect FDA’s approved indications for ceftiofur. The veterinarian’s ability to prescribe ceftiofur for FDA-approved uses in food animals is unchanged. —WLJ