EXTRA-LABEL/OFF-LABEL USAGE and WITHDRAWAL TIMES OF MEDICATIONS

What do the terms "extra label" and "off label" mean? Can extra label or off label drugs (antibiotics and anthelmintics) be lawfully used with goats?

Administration of products which are not labeled as approved for use in a specific species is known as extra label or off label usage. All but a very few of the medications that are used with goats have been developed for other species of animals. Drug manufacturers have not spent the time or money to complete and submit expensive detailed research studies to obtain government approval to label them for use with goats. The US goat population has droped from 12 million head in 1990 to less than two million goat in 2013. the goat population is even lower now.

Drug manufacturers haven't invested money to obtain label approval because the total number of goats in the USA is too small for them to recoup their costs and earn a profit. A good example is the development and conditional approval of a CL vaccine for goats by Texas Vet Lab in San Angelo, Texas in 2012 and the company's decision not to renew the license in 2021 due to insufficient sales.

There are many reasons for this drop in numbers, despite increased demand, which I address in another article.

Goat raisers have to learn what works and doesn't work from knowledgeable and experienced goat raisers or from the few vets knowledgeable about goats. Dosage amounts and frequency of administration have to be adjusted to fit the goat's fast metabolism. Some cattle medications are toxic to goats; the antibiotic Micotil will kill a goat instantly.

Goat raisers often have more knowledge of what drugs work than many veterinarians. The reason that I maintain goat discussion groups on www.groups.io and elsewhere on the internet is to share information that is not readily available and to correct the vast amount of bad information being published about medicating goats.

Using drugs extra label/off label is not illegal as long as the goat raiser has a good working relationship with a veterinarian and the vet has advised him on the proper use and dosage of the drugs. Develop a good relationship with your vet so that he knows about, supervises, and approves of your drug management practices.

WHAT DOES 'WITHDRAWAL TIME" OF MEDICATIONS MEAN?

Drugs remain in the meat and/or milk of food animals for different lengths of time. The US Government is concerned that drug residues in meat or milk destined for human consumption will result in developing resistance when those drugs are used on humans. AMR is the term given this situation: ANTI-MICROBIAL RESISTANCE. There is concern that "super bugs" may develop resistance to all known forms of antibiotics. The result might be detrimental to human health. Goat raisers should carefully evaluate the appropriateness of every medication; antibiotics, for example, should not be used unless symptoms indicate the need for them. Antibiotics are generally needed when fever exists, for example.

Veterinarians tend to recommend drugs with shorter withdrawal times. Unfortunately, some drugs having shorter withdrawal times are also not effective with goats. For example, Panacur (the veterinarian brand name for Safeguard) has a very short withdrawal time in milk and meat. Even though it almost never kills stomach worms in goats, many vets will recommend its use instead of other dewormers such as 1% Ivermectin, which has a longer (approximately 35 day) withdrawal time.

A better approach would be for the vet to be aware of what each client's goats are being raised for. If they are breeding stock animals or pets, then withdrawal time is less critical. If the goats are being raised to produce milk or meat for human consumption, then withdrawal times should be of more concern. To my knowledge there is no real reason human-health-wise to be concerned about anthelmintic (dewormer) withdrawal time in humans, but this remains a big issue in some goat venues. In some countries, humans regularly take oral dewormers, but not in the USA.

Vets and other licensed professionals are held to a much higher standard than unlicensed people. Even if they know that a product works, veterinarians may believe that they are risking their licenses by recommending off label/extra label usage. Using Formalin to control CL abscesses is a good example. It isn't illegal, but it also has never been reviewed for effectiveness or safety by drug companies or government agencies, so vets and other people with professional designations may react with horror if you broach this subject with them. That reaction does not mean that it doesn't work or is unsafe. It simply means that they are taking a very conservative CYA ("cover your a--"). This is understandable.

Some of you may say, "let's just get the government to look into it and give the OK to such usage." Be careful what you wish for. Bureaucrats and politicians have never seen an area that they would not wish to take over and regulate forever. Raising goats is difficult enough without giving mandatory rule-making power to people with very limited knowledge of agriculture in general and goat health in particular.

DRUGS THAT ARE ILLEGAL TO USE WITH GOATS

There are medications which are illegal for use in certain species of food animals in some states. Baytril 100 is one of those drugs. Baytril 100 is legal to use with cattle but illegal to administer to goats. You may ask why, with both of these species being food animals, Baytril 100 is legal in one species (cattle) yet illegal in the other (goats). The answer: money and politics. The cattle industry is highly organized with lots of money available for lobbying for favorable research, testing , and Federal approval to allow use of drugs. The goat industry is fragmented and without significant national representation. If you are looking for logic, the regulatory arena is not where you'll find it.

Vet consultation is advisable before using drugs on animals whose meat or milk is destined for human consumption. In June 2023, many more "anti-microbials" become available only through vet prescription. Establish a relationship with a vet if you want to be able to buy them for use with your goats.

I am not a veterinarian and I make no specific recommendations either pro or con for off label/extra label usage of drugs. Consult your veterinarian. This article is intended to educate and inform only.

Suzanne W. Gasparotto, ONION CREEK RANCH, Texas 3.1.23

The author, Suzanne Gasparotto, hereby grants to local goat publications and club newsletters, permission to reprint articles published on the Onion Creek Ranch website under these conditions: THE ARTICLE MUST BE REPRODUCED IN ITS ENTIRETY AND THE AUTHOR'S NAME, ADDRESS, AND CONTACT INFORMATION MUST BE INCLUDED AT THE BEGINNING OF THE REPRINT. We would appreciate notification from any clubs or publications when the articles are used. (A copy of the newsletter or publication would also be a welcome addition to our growing library of goat related information!)

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