What You Don't Know Could Hurt

As a horse owner, you are regularly bombarded with advertisements for various products that will supposedly cure your horse's arthritis. On the other hand, you might have noticed that your veterinarian uses pharmaceutical products that are approved by the Food and Drug Administration (FDA) and you only have access to them through a veterinarian's administration or prescription. It is important to realize that FDA approval brings assurance that your veterinarian is using a product that has met stringent standards for quality, consistency, and safety. Veterinarians know that unapproved pharmaceuticals that are not subjected to rigorous approval and monitoring processes of the FDA can present unnecessary risks to their patients and practice. Many horse owners and trainers are unaware of the facts and ramifications associated with the pharmaceutical products not approved by the FDA, particularly if an unexpected, adverse reaction occurs.

"Science is the cornerstone of good regulatory decisions," according to former FDA Commissioner Jane E. Henney, MD. "While statutes such as the Federal Food, Drug and Cosmetic Act give the FDA the authority to regulate various industries and products, it is the science that provides the knowledge needed to develop and apply the regulations in the right way." The Federal Food, Drug and Cosmetic Act of 1938 (known as FDCA) provides clear-cut definitions for an FDA-approved animal drug. It must be:

  • Safe for the animal by FDA acceptance of the required Target Animal Safety Studies;
  • Effective by FDA acceptance of the required Clinical Efficacy and Safety Studies;
  • Manufactured at an FDA-approved facility under stringent quality controls, including Good Manufacturing Practices, to assure strength, identity, purity, and potency; and
  • Continually monitored for safety, efficacy, and side effects through rigorous post-approval reporting requirements.

FDA approval is a long, costly process; however, it exists to assure the availability of quality-controlled, safe, and effective products for veterinarians and their patients. Ethical pharmaceutical manufacturers have made the decision to invest in this process with all of the associated risks and expense. These same quality control measures cannot be assumed if a veterinarian chooses an unapproved pharmaceutical product or the owner or trainer buys non-approved products without consulting a veterinarian.

There are several unapproved pharmaceutical products in the marketplace that are often presented to the veterinarian, owner, or trainer as "just like...only cheaper" or "the same as," but these comparisons are unproven. Horse owners and veterinarians should not be misled by this type of promotion.

An important question for equine veterinarians comes down to what is effective, as well as safest, for the patient, client, and practice. If an FDA-approved pharmaceutical product is available, use of an unapproved product might conflict with FDA regulations. "Without a clear understanding of the guidelines, veterinarians may believe off-label use of some products is simply a less expensive option for their clients based on per treatment comparison costs," according to Richard Mitchell, DVM, Fairfield Equine Associates in Newtown, Conn. "In reality, the risks of off-label use could cost a lot more than dollars."

Another very important factor to consider is that an approved pharmaceutical product ensures the use of appropriate medications based on accurate diagnosis by a licensed veterinarian. All too commonly, the veterinarian becomes involved in the case after other treatments have been tried.

I am not saying that various nutraceuticals available to the horseman do not work. However, there is a lack of controlled proof of effectiveness, whereas the licensed medications have that controlled support. We need to encourage producers of these other products to really prove their worth (much of the advertised proof is extremely shaky). At the same time, participation of a veterinarian making an accurate diagnosis before treatment commences is critical for successful management of your horse.

About the Author

C. Wayne Mcllwraith, BVSc, FRCVS, PhD, Dipl. ACVS, Dipl. ECVS

C. Wayne McIlwraith, BVSc, FRCVS, PhD, Dipl. ACVS, Dipl. ECVS, is Director of the Orthopaedic Research Center, Veterinary Teaching Hospital at Colorado State University, and a past president of the American Association of Equine Practitioners.

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