Benefits of FDA Approved Products
FDA Approved Drugs vs. Medical Devices, Compounded Drugs and Supplements/Nutraceuticals There are many products marketed for treatment of equine degenerative joint disease. The different products available include FDA approved pharmaceuticals, veterinary medical devices, compounded drugs, and supplements/nutraceuticals. So, how can you evaluate these options? Here is some important information that should help you form your own opinion.
FACTS about FDA approved drugs Arrow Up
FDA Pioneer Drug:
  • A drug that has been rigorously tested by undergoing blinded and controlled clinical studies to investigate its safety and efficacy and in accordance with FDA mandated standards and regulations such as Good Clinical Practices (GCPs)
  • The active ingredient and product were manufactured under FDA mandated Good Manufacturing Practices (GMPs) in regularly inspected plants
  • Therapeutic consistency, product quality, accurate drug shelf life, and scientifically substantiated labeling are all FDA mandated for these products
  • Stringent testing standards for drug potency and purity must be established and stability data generated in order to determine expiration dating
  • Detailed records of each batch of drug produced must be maintained and representative samples of each batch of drug retained for future testing
  • Continual monitoring for adverse events, safety, and efficacy is conducted by the manufacturer and must be regularly reported to the FDA
FDA Approved Generic Drug: A generic drug is bioequivalent to a brand-name drug in dosage form, efficacy, safety, strength, route of administration, quality and intended use. True generic drugs are chemical copies of brand-name drugs that are no longer patent protected. Generic drug labels display an ANADA number or ANDA number signifying FDA approval of the generic animal drug or human drug, respectively. Generic drugs and their active ingredients also must be manufactured under GMP in federally inspected plants.1 FDA Approved Drugs Are Subject to the Following Standards:
  • Drug Efficacy in at least two well-controlled trials one of which must be in clinical cases
  • Drug Safety in one or more studies in the target species
  • All active ingredients for drug manufacture must be obtained from an FDA registered and inspected source
  • A manufacturing procedure that meets the rigorous standards of the Good Manufacturing Practices (GMP) overseen by FDA
  • Stringent testing for drug potency and purity must be established
  • Stability data generated in order to establish the expiration dating
  • Detailed records of each batch of drug produced must be maintained
  • FDA regularly inspects manufacturing facilities
  • Continual monitoring for adverse events, safety and efficacy
How can YOU tell if a product is FDA Approved? Many veterinary products may appear to be similar to pharmaceuticals. However, ONLY FDA approved pharmaceuticals are given a 6 digit New Animal Drug Application (NADA) or Abbreviated New Animal Drug Application (ANADA for generics) number. Look on the products label or outer box to ensure that the product is FDA approved. The location of the NADA number for BetaVet® is located toward the bottom of the outer box; for Adequan® the NADA number is located on the bottom of the vial label.1 You can also visit www.fda.gov for more information on approved drugs.

Adequan® (polysulfated glycosaminoglycan) is the ONLY product in its class approved by the FDA for the intramuscular treatment of non-infectious degenerative and/or traumatic joint dysfunction of the carpal and hock joints in horses.

BetaVet® (betamethasone sodium phosphate & betamethasone acetate) is the only dual ingredient injectable corticosteroid approved by the FDA for use in horses.
FACTS about veterinary medical devices: Arrow Up
A medical device as defined by the Food and Drug Administration in the Food Drug and Cosmetic Act, Section 210(h): “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component part, or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or animals and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and is not dependent upon being metabolized for the achievement of any of its principal intended purposes.”2 Examples include: Needles, syringes, prosthetic devices, x-ray equipment, MRI unit, pacemakers, stents, surgical lasers, shock-wave unit, and barriers in the form of sheets or solutions, etc. It should always be preferable to use FDA-approved products over options which are not required to demonstrate safety or efficacy, are not routinely monitored and are not regulated with the same level of scrutiny.
FACTS about compounded drugs: Arrow Up
A Compounded Drug is any drug manipulated to produce a new dosage form drug. Compounded products are:
  • NOT FDA APPROVED
  • NOT GENERIC DRUGS
Legal compounding requires a valid veterinarian-client-patient relationship (VCPR). Use of compounded drugs should be limited to unique needs in specific animals and to those uses for which a response to therapy can be monitored, or those for which no other method or route of drug delivery is practical or available. It is illegal to compound a specific product when there is an approved drug form of that product except to make a different dosing form. However, the approved product must be used to make the compounded new dose form. Bulk compounding and sales is illegal. The prescribing veterinarian and owner should remember that compounded drugs are not subject to the FDA approval process for testing for safety, efficacy, stability, potency and consistency of manufacturing. Consistency from one batch to another, amount of the stated drug substance, and safety and efficacy for the intended use cannot be ensured.1 Compounded Drug Considerations:
  • No regulations on raw material sources
  • No quality standards batch to batch
  • No requisite stability data
  • Illegal to put expiration dating beyond 180 days
  • Compounding pharmacies are not required to carry liability insurance
  • No required monitoring for safety, efficacy, ADEs
  • The prescribing veterinarian is responsible for safety and efficacy monitoring1
FACTS about supplements/nutraceuticals: Arrow Up
Oral joint supplements are loosely classified as nutraceuticals. The term “nutraceutical” combines the word “nutrient” (nourishing food or food component) with “pharmaceutical” (a medical drug) and describes a broad list of products sold under the premise of being a dietary supplement (i.e., a food) but for the expressed intent of treatment or prevention of disease. The variety of claims to aid in equine joint health are often unsupported. The potential difference between a feed and a nutraceutical is that a nutraceutical is unlikely to have an established nutritive value. Feeds are required to have nutritive value and are accountable, by labeling, for these values. Joint supplements fall in between food and drug and have marketing advantages over both because they are not required to list ingredients or nutrient profiles as required by feeds, and in many cases are intended to treat or prevent disease without first undergoing proper drug approval.3
  • Supplements/nutraceuticals are not regulated by the FDA to the same extent
  • No direct oversight regarding disease treatment or prevention claims
  • No pre-market approval process
  • No requirement for monitoring of safety or efficacy
Available product comparison summary Arrow Up
As always, when you encounter different products in the marketplace, we encourage you to seek the advice of your veterinarian and discuss the importance of FDA approved treatment options. It should always be preferable to use FDA-approved products over other products available in the equine marketplace which are not required to demonstrate safety or efficacy, are not routinely monitored, and are not regulated with the same level of scrutiny.

*There have not been any published head to head comparisons with regard to superiority/efficacy.
Product Comparison Chart4, 5, 6



References:
1. Equine Veterinary Compounding Guidelines. American Association of http://www.aaep.org/custdocs/drug_compounding_guidelines.pdf. Accessed August 4th, 2016. 2. Stanley SD. Legal and Ethical Veterinary Compounding. AAEP. 2009. 3. The Biological and Therapeutic Agents Committee. Medical Devices: A White Paper on Medical Devices in Equine Medicine. American Association of Equine Practitioners. Approved by the AAEP Board of Directors July 2010. Accessed June 21, 2016. 4. McIlwraith CW. Management of joint disease in the sport horse. Proc of 2010 KY Equine Res Nutrition Conf. 2010; 61. 5. Product Comparison Chart. American Association of Equine Professionals. http://www.aaep.org/custdocs/Product Comparison Chart.pdf. Accessed September 21, 2016. 6.Safety of Dietary Supplements for Horses, Dogs, and Cats. Report in Brief. The National Academy of Sciences. http://dels.nas.edu/resources/static-assets/materials-based-on-reports/reports-in-brief/satety_of_dietary_supplements_final.pdf . Accessed September 21, 2016. 7. Companion Animals: Dietary Supplements in Companion & Exotic Animal Nutrition – Use, Regulations & Safety. J. Anim. Sci. Vol. 87, E-Suppl. 2/J. Dairy Sci. Vol. 92, E-Suppl. 1. 2009.


Adequan® i.m. INDICATIONS For the intramuscular treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses. IMPORTANT SAFETY INFORMATION Studies have not been conducted to establish safety in breeding horses. WARNING: Do not use in horses intended for human consumption. Not for use in humans. Keep this and all medications out of the reach of children. CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Adequan® I.A. INDICATIONS For the intra-articular treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal joint in horses. IMPORTANT SAFETY INFORMATION Inflammatory joint reactions and septic arthritis have been reported following administration of Adequan® I.A. Joint sepsis, a rare but potentially life threatening complication, can occur after intra-articular injection. Use only in the carpal joint of horses. WARNING: Do not use in horses intended for human consumption. Keep this and all medications out of the reach of children. CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
BetaVet® INDICATIONS BetaVet® is indicated for the control of pain and inflammation associated with osteoarthritis in horses. IMPORTANT SAFETY INFORMATION For Intra-articular (I.A.) use in Horses. CONTRAINDICATIONS: BetaVet® is contraindicated in horses with hypersensitivity to betamethasone. Intra-articular injection of corticosteroids for local effect is contraindicated in the presence of septic arthritis. WARNINGS: Do not use in horses intended for human consumption. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Additionally, corticosteroids administered to dogs, rabbits and rodents during pregnancy have resulted in cleft palate in offspring and in other congenital anomalies including deformed forelegs, phocomelia and anasarca. Therefore, before use of corticosteroids in pregnant animals, the possible benefits to the pregnant animal should be weighed against potential hazards to its developing embryo or fetus. Human Warnings: Not for use in humans. For use in animals only. Keep this and all medications out of the reach of children. Consult a physician in the case of accidental human exposure. PRECAUTIONS: Corticosteroids, including BetaVet®, administered intra-articularly are systemically absorbed. Do not use in horses with acute infections. Acute moderate to severe exacerbation of pain, further loss of joint motion, fever, or malaise within several days following intra-articular injection may indicate a septic process. Because of the anti-inflammatory action of corticosteroids, signs of infection in the treated joint may be masked. Due to the potential for exacerbation of clinical signs of laminitis, glucocorticoids should be used with caution in horses with a history of laminitis, or horses otherwise at a higher risk for laminitis. Use with caution in horses with chronic nephritis, equine pituitary pars intermedia dysfunction (PPID), and congestive heart failure. Concurrent use of other anti-inflammatory drugs, such as NSAIDs or other corticosteroids, should be approached with caution. Due to the potential for systemic exposure, concomitant use of NSAIDs and corticosteroids may increase the risk of gastrointestinal, renal, and other toxicity. Consider appropriate wash out times prior to administering additional NSAIDs or corticosteroids. ADVERSE REACTIONS: Adverse reactions reported during a field study of 239 horses of various breeds which had been administered either BetaVet® (n=119) or a saline control (n=120) at five percent (5%) and above were: acute joint effusion and/or local injection site swelling (within 2 days of injection), 15% BetaVet® and 13% saline control; increased lameness (within the first 5 days), 6.7% BetaVet® and 8.3% saline control; loose stool, 5.9% BetaVet® and 8.3% saline control; increased heat in joint, 2.5% BetaVet® and 5% saline control; and depression, 5.9% BetaVet® and 1.6% saline control. DOSAGE AND ADMINISTRATION: Shake well immediately before use. Use immediately after opening, then discard any remaining contents. Use immediately after opening, then discard any remaining contents. RX ONLY


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Or Call Customer Service Today! (800) 458-0163


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