April Knudson, DVM, is an equine specialist with Merial Veterinary Services. She has a special interest in equine gastrointestinal health, infectious disease and lameness. She holds a doctor of veterinary medicine from the University of California-Davis. Below, she answers a question about how to evaluate the products available to horse owners.
Question: There are so many different versions of drugs available to purchase for my horse. How do I know which ones really work and are safe to use?
Answer: As with any other area of equine health care, it is always best to consult with your veterinarian about providing the best possible medicine, including the risks and benefits of any product before giving it to your horse. There are many companies out there making claims that their products are “just like” others you may have used, but this is often just not the case.
When you decide to buy a product—specifically a drug—for your horse, it’s important to make sure you really know what you are getting. Having a better understanding of a few definitions may help as you and your veterinarian evaluate and make decisions about your horse’s health care.
Approved by the Food and Drug Administration (FDA), brand-name drugs must comply with the agency’s strict testing, manufacturing and labeling guidelines. FDA approval of a drug means:
The product meets quality, purity and potency specifications.1
Each unit is consistently manufactured under what are called “Good Manufacturing Practices” (GMP).1
The safety and efficacy of the product is based on thorough scientific review prior to approval.1
The drug is continually monitored by the FDA after it is on the market to ensure product performance, as well as identify any concerns or questions.1
Even if these drugs are not manufactured in the United States, the facilities they are made at are still subject to FDA approval and inspection.2
These drugs are given a New Animal Drug Application (NADA) number and they can be found by searching the database accessed through AnimalDrugs@FDA.1
Brand-name drugs may require a prescription or be available over-the-counter (OTC) – but both types still require FDA approval. In the U.S., horse owners are encouraged to go to the FDA site and search a drug’s name to make sure it has been manufactured to the standards they expect.
Generic is frequently a misused and misunderstood term. A generic drug, for which FDA approval is still required, must contain the same active ingredients as the original formulation.3 The generic must also be comparable to the brand-name drug in dosage form, safety, strength, route of administration, quality and intended use.3
A generic is NOT the same as a compounded drug nor does it simply mean an OTC version of a prescription drug. Upon FDA approval, generic drugs are given an Abbreviated New Animal Drug Application (ANADA) number.1 Sadly, some horse owners are led to believe that drugs they find online or from alternative sources are true generics, but often these products have not been reviewed by the FDA and are from unapproved foreign or U.S. sources that have not gone through safety or efficacy testing.
For example, despite what has been claimed in some product promotions,4-6 there are NO generic versions of ULCERGARD® (omeprazole) or GASTROGARD®(omeprazole). In the U.S., ULCERGARD is the only FDA-approved product for the prevention of equine stomach ulcers,7 and GASTROGARD is the only FDA-approved product for the treatment of equine stomach ulcers.8
If you have been told an omeprazole-containing product you are using is a “generic” of these products, you can be assured that is false. Just ask for the ANADA number. A quick visit to AnimalDrugs@FDA would confirm if this drug has been approved by the FDA. If the drug has not been FDA-approved, you have no guarantees of what may or may not be in that product – or in what type of conditions it has been manufactured.
Compounding can be a confusing topic. Contributing to that confusion is the fact that some product compounding is legal, while other compounding practices may not be.
Legal compounding is the manipulation of an FDA-approved drug for the purpose of meeting the needs of a specific patient.1 For a drug to be legally compounded and made available to a horse owner, many rules apply, including, but not limited to: a valid veterinarian-client-patient relationship exists, a licensed veterinarian or pharmacist must compound the product and there must not be an FDA-approved drug available.1Examples of legal compounding include crushing a pill to create an oral suspension, adding a flavor to a commercially accessible drug or mixing two different injectable drugs together.1
Unfortunately, many equine drugs, including ULCERGARD and GASTROGARD, ADEQUAN®, BANAMINE®, Phenylbutazone, PROTAZIL® and REGU-MATE® are illegally manufactured under the guise of compounding and marketed to horse owners. It is important for horse owners to know compounded products are not approved by the FDA. Nor are compounders required to comply with the FDA’s safety, efficacy and manufacturing guidelines, which help ensure the quality, purity and potency of FDA-approved products.1 For example, there have been multiple studies showing that compounded omeprazole products are not as effective and often have great variations in the amount of active ingredient versus what the label claims.9,10
Horse owners also have access to many nutritional and dietary supplements. While the FDA does not “object to the marketing of nutritional supplements for oral administration to companion animals,”11 those supplements are not held to the safety and efficacy testing that FDA-approved drugs are. Their manufacturers cannot legally make any claims of disease prevention or treatment.12 However, a significant number of these products do make claims that cannot be substantiated by scientific data. 13 Horse owners should be wary of using these products as a replacement for drugs that have undergone more extensive and critical scientific review. It’s never a bad idea to ask the manufacturer for peer-reviewed, published data that supports the product claims. It’s another step in the purchase process, but it’s an important one.
With all of this information, it’s no wonder owners often feel confused about what products to buy for their horses. Tips that will help you navigate this maze include consulting with your veterinarian, doing your homework and asking questions if you’re unsure or product claims seem too good to be true. What you learn could make a difference in your horse’s health, and, in the long run, your pocketbook.
For more information about ULCERGARD and GASTROGARD, visit www.ulcergard.com and www.gastrogard.com.
IMPORTANT SAFETY INFORMATION: CAUTION: Safety of GASTROGARD in pregnant or lactating mares has not been determined. ULCERGARD can be used in horses that weigh at least 600 pounds. Safety in pregnant mares has not been determined.
®GASTROGARD and ULCERGARD are registered trademarks of Merial Limited. All other marks are the property of their respective owners. ©2012 Merial Limited, Duluth, GA. All rights reserved. EQUIUGD1204-r (05/12)
1Animal Health Institute and American Veterinary Medical Association and American Veterinary Distributors Association. Veterinary Compounding. Available at: http://www.aaep.org/siteadmin/modules/page_editor/images/files/AHI%20 Compounding.pdf. Accessed February 9, 2012.
2 U.S. Department of Health and Human Services. Food and Drug Administration. FDA Basics. How does FDA oversee domestic and foreign drug manufacturing? Available at: http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194989.htm. Accessed February 29, 2012.
3 U.S. Department of Health and Human Services. Food and Drug Administration. What are generic drugs? Available at: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicine
Safely/UnderstandingGenericDrugs/ucm144456.htm. Accessed February 29, 2012.
4 Omeprazole Direct Website. http://equine.omeprazoledirect.com/. Accessed February 9, 2012.
5 Canada Generic Website. http://www.canadageneric.com/index/cfm./fuseaction/product.display/pn/
ulcergard/product.display/pn/ulcergard/product.id/9697.htm. Accessed February 9, 2012.
6 OTCVetMeds Website. http://www.otcvetmeds.com/equine-stomach-ulcers/gastrogard.html. Accessed February 9, 2012.
7 ULCERGARD product label.
8 GASTROGARD product label.
9 Stanley SD, Knych HK. Comparison of Pharmaceutical Equivalence for Commercially Available Preparations of Omeprazole. AAEP Proceedings. 2011;57:63.
10 Nieto JE, et al. Comparison of paste and suspension formulations of omeprazole in the healing of gastric ulcers in racehorses in active training. JAVMA. 2002;8:1-5.
11Compliance Policy Guides. Nutritional Supplements for Companion Animals. Available at: http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074708.htm?utm_source=fdaSearch&utm_medium=website&utm_term=nutritional%20supplement%20animal&utm_content=1. Accessed May 1, 20112.
12Pharmaceutical Market Research. Nutraceuticals for The Animal Health Industry. Market Research Report. January 2007. Available at: http://www.pharmaceutical-marketresearch.com/publications/animal_veterinary/nutraceuticals_animal_health_industry.html. Accessed February 9, 2012.
13 Crandell K, Duren S. Nutraceuticals: what are they and do they work? Kentucky Equine Research, Inc. Available at: http://www.ker.com/library/advances/203.pdf. Accessed February 1, 2012.