The Food and Drug Administration’s (FDA’s) new rules tightening the use of cephalosporins in food animals may end up affecting how swine veterinarians and producers 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 swine producers are familiar with are the injectable ceftiofur products Naxcel ®, Excede ®, and Excenel® and the human drug cephalexin, of which water soluble preparations have sometimes been used to treat swine respiratory problems.

Because of their close relation to drugs used in people, the FDA has sought to clamp down on the uses of cephalosporin antibiotics in animals.  In 2008, the FDA proposed rules that would mean these drugs could only be used strictly according to their labels, even by veterinarians.  The rules currently proposed 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, cephalexin, a drug that has not been specifically approved for use in swine (only labeled for humans), would no longer be allowed in food animals.  Veterinarians by law have been able to use human-labeled antibiotics to treat sick animals when no labeled food animal drug is available.  This would no longer be the case for cephalosporin drugs under this latest proposed rule. 

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 pigs that are not listed on the label.  For example, under a VCPR, a veterinarian or producer could still use these drugs to treat a joint infection in a sow, despite that not being a listed use on the label.  What will not be allowed, 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 injecting IV a preparation labeled for intramuscular use).  In short, producers and veterinarians can use these drugs for conditions not listed on the label.  These injectable ceftiofur 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.  Questions arise about the use of these antibiotics in medicated weaning programs: is this use “prevention” (which would not be allowed) or is it “control” (which is allowed on current labels)?  Swine producers should discuss the ramifications of these new regulations with their veterinarians.