The U.S. Food and Drug Administration’s (FDA) action to prohibit the “extralabel” use of cephalosporin drugs in food-animal production is now in effect. FDA specifically cites cattle, swine, chickens and turkeys, as the “major species of food-producing animals.”
The order was announced on Jan. 6, and followed with a 60-day comment period, which closed on March 6. FDA officials reviewed the submitted comments and determined that the order of prohibition should go into effect on April 5, “without further revision or delay.”
FDA officials say they are taking this action to “reduce the risk of cephalosporin resistance in certain bacterial pathogens” and to preserve the drug’s effectiveness in treating disease in humans.
Extralabel use is when a drug is used in a manner other than what is designated on a specific product’s label. FDA offers these guidelines as prohibited uses:
- Using cephalosporin drugs at unapproved dose levels, frequencies, durations or routes of administration;
- Using cephalosporin drugs in cattle, swine, chickens or turkeys that are not approved for use in that species (for example, cephalosporin drugs intended for humans or companion animals);
- Using cephalosporin drugs for disease prevention.
Cephalosporin drugs may still be used as designated on a product’s label for the treatment of a specific disease within a species.
What this means for swine veterinarians and pork producers is that, “effective immediately, cephalosporins cannot be prescribed for use in an extralabel manner except for indications not included on the label and then only at the dose, frequency, duration and route of administration described on the label,” points out the American Association of Swine Veterinarians. “Also, cephalosporins intended for use in humans or companion animals are prohibited for use in swine as is any use for disease prevention.”