If you’re told that some of our drug and animal health regulations don’t need to be followed, you’re getting bad advice. If you take that advice, you’re breaking the law.
If you’re putting a fluoroquinolone antibiotic into cattle for anything other than respiratory disease, you’re breaking the law. This class of antibiotics includes enrofloxacin (Baytril 100®) and danofloxacin (Advocin™). Illegal uses would include treatment of diarrhea (scours) or ear infections.
These drugs were approved with a prohibition of extralabel (EL) use because of their importance in human medicine, and the intent to limit their uses to only those diseases where microbial safety has been demonstrated. The fluoroquinolone antibiotics are only labeled to treat and control respiratory disease in cattle (only enrofloxacin for control, which means metaphylaxis, or mass medication on arrival), for which this use has been proven safe and effective. Any other use in cattle is illegal.
There is another recent rule regarding EL use in food animals. The antibiotic ceftiofur is in the third-generation cephalosporin class. You know this drug by the trade names Naxcel®, Excenel® and Excede®, all of which contain ceftiofur in different formulations. This antibiotic has been proven safe and effective for multiple label indications.
Recently, FDA’s Center for Veterinary Medicine prohibited certain EL uses of this antibiotic because of the importance of this class of antibiotics in human medicine. Ceftiofur may be used for diseases other than specified on the label under the supervision of a veterinarian, but in no cases may the label directions for administration be altered (dose, route, duration, frequency).
Therefore, injecting Excede subcutaneously in the neck is illegal; it is labeled only for injection in the middle third or at the base of the ear. If Excede is injected anywhere else, the withdrawal time is so long that there’s a chance the carcass could be pulled and tanked — with the client receiving zero for a $1,500 steer.
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There’s been lively debate about the scientific justification for the EL prohibitions for both of these drug classes. Regardless of your thoughts on this issue, these are the regulations, and the ability to limit uses of these antibiotics through label specifications and EL prohibitions is the reason our industry still has some of our antibiotics. Just as important, it’s the reason we may get new ones in the future.
Through my observations of food animal veterinarians and producers over the years, there are some characteristics I’ve noted among those striving to do things right. These people understand that:
- Their success, and that of their colleagues and neighbors, depends on the success of the industry as a whole.
- This success is understood to encompass a long-term horizon, including future generations.
- This success is completely dependent on the willingness of a consumer to purchase the end product, which is based not only on price, but also on perceptions related to animal welfare and product safety.
Anyone who suggests picking and choosing the regulations to observe doesn’t understand these relationships. If you see an industry demonstrate it will pick and choose which regulations it follows, are you comfortable doing business with that industry? What about an industry that tolerates some of its members ignoring some of the rules?
Our willingness as an industry to adhere to regulations will determine if label directions, EL use regulations and veterinary oversight will continue to serve as sufficient assurances to allow approval of new tools for animal health and to keep the ones we have. Our responsibility includes both being involved in the regulatory process through our veterinary and producer organizations, and being very vocal about not tolerating lack of adherence to the regulations once they are in place.
If you’re told that some of these regulations don’t need to be followed, you’re getting bad advice. If you take that advice, you’re breaking the law.
Mike Apley, DVM, Ph.D., is a professor in clinical sciences at Kansas State University in Manhattan.
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