The FDA “protects” us one more time

This statement was issued by The FDA’s Center for Veterinary Medicine recently. It may not seem that important until you look closer at what antibiotics are involved and the message being telegraphed between the lines.

For years veterinarians have had the privilege of prescribing extra-labeled drug use (ELDU) of most antibiotics, with a few exceptions. They had to follow some guidelines: Practitioners must have a veterinarian-client-patient relationship with the farm or in the case of small animals with the owner. They must also have determined that other drugs, or the one under consideration at a lower dose or frequency of administration, haven’t proven effective. The old standby – penicillin - is the most common example of ELDU. It’s invariably used in much higher doses than the label recommends because lower dosing is just ineffective.

What makes this proposed rule so ominous? The cephalosporin group contains one of the most widely used and effective family of food animal antibiotics that we have – ceftiofur. These are marketed under the trade names Naxcel®, Excenel® and Excede®. The cephalosporins are rapidly metabolized, hence the short withholding times, and are not persistent in the environment. These factors reduce the risk of human exposure to resistant strains and helped win the original approval process.

As a relatively broad spectrum antibiotic, cetiofur has been effectively and safely used beyond its labeled claims for mastitis, metritis, foot rot and pneumonia. Septicemia, peritonitis and joint ill are examples of conditions routinely treated with cetiofur in an off-label fashion. Often times the dose is increased and the length of treatment is drawn out to facilitate a cure.

The new FDA rule will eliminate the ability to legally treat these conditions with any cephalosporin. The alternative antibiotics have longer residues, more resistance and less ease of administration. The potential detrimental effect to humans would actually increase.

The food animal veterinary profession appears to be mounting a spirited response during the FDA comment period prior to a final decision this fall. Their small animal counterparts won’t be hindered by the proposed rule despite the fact that more humans have closer contact with pets that might harbor antibiotic resistant bacteria.

The awkward position veterinarians are in regarding antibiotic use will enter into the conversations with FDA. Practicioners control the script writing side of the prescription- labeled drug. Over-the-counter products, however, can be purchased and used extra-label without an attending veterinarian’s knowledge. Technically, an ELDU label must be applied by the veterinarian to be legally used in this manner.

The federal government wants more control of antibiotic use and seeks to get it through veterinarians. It knows who we are and where we work. And it can take our licenses away if we don’t follow the rules.

The catalogs and route trucks only sell products with as-approved FDA uses and dosage whether over the counter or by prescription. If ELDU occurs on a farm, it’s not their concern. But it does put the attending vet on the spot if an inspector finds their label on some products and not on others. The source of supply isn’t apparent at a glance.

Talk to your veterinarian about this issue. See what you can do to pressure your politicians to craft a rule that is rational and wise.

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