Food and Drug Administration Q&A
FDA-approved products provide peace of mind for horse owners.
By Dr. April Knudson of AQHA Corporate Partner Merial | July 18, 2012
Question: I've heard that I should only use drugs that have been approved by the U.S. Food and Drug Administration. Why is that?
Answer: That’s a great question, because with all the drugs and products available to horse owners, sorting through them can be a challenge. Should you choose based on price, your trainer’s suggestion or maybe what worked for a friend’s horse?
While these might be used as secondary considerations, none of them should drive your decision when selecting a drug to give to your horse. Instead, that decision should be made based upon your veterinarian’s recommendation and whether or not the product has been approved by the FDA.
Drugs approved by the FDA provide horse owners with the peace of mind that they have been thoroughly tested for both safety and effectiveness.1 So what does that mean to the health of your horse?
We know you love and care for your horses, spend hours grooming them to a glimmering shine, drive countless hours to the best trainers money can buy, and give them all your love and attention. But how much do you really know about keeping your horse healthy? Purchase the three-disk "Your Horse's Health" DVD collection and learn the basics of keeping your horse healthy.
During a new drug’s development phase, the company bringing it to market conducts tests to demonstrate the safety of the proposed product in the target animal.2 Tests are also conducted to confirm the efficacy of a product.2 When the labeling and subsequent advertising are developed, the FDA regulates what claims can and can’t be included.3 The FDA’s stringent labeling guidelines help ensure that product claims are fair and accurate and that horse owners will be aware of any possible risks associated with the product.3
After a drug is approved by the FDA and available on the market, the agency continues to monitor it, including any adverse events that may occur.1 This helps identify any problems that may arise and enables companies to address them quickly.
Unfortunately, some drugs are produced and marketed to horse owners that are not FDA-approved and therefore have not undergone safety and efficacy testing. In many instances, these products make claims that have not been proven.4-6 Examples of products being falsely marketed are any that advertise themselves to be the equivalent of Ulcergard® (omeprazole) or Gastrogard® (omeprazole),4-6 which are the only FDA-approved products for the prevention7 and treatment8 of equine stomach ulcers.
Other products all horse owners should be wary of are those claiming to be the equivalent of
Adequan® (polysulfated glycosaminoglycan), Banamine® (flunixin meglumine), phenylbutazone, Protazil® (diclazuril), and Regu-Mate®. Non FDA-approved counterfeit versions of these drugs are also widely available. Taking chances with any product that has not been FDA-approved and therefore does not meet safety and efficacy standards means your horse may continue to suffer and you may be wasting money.
So how can you tell if a product has FDA approval and adheres to its stringent guidelines? Look for the six-digit New Animal Drug Application (NADA) number, or in the case of generics, the Abbreviated New Animal Drug Application (ANADA) number, on the label. Or, look up the drug in the searchable database at AnimalDrugs@FDA.
Remember, if you have any doubts, consult your veterinarian.
For more information about Ulcergard and Gastrogard, visit www.ulcergard.com and www.gastrogard.com.
Dr. April Knudson 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 degree from the University of California-Davis.
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. ©2012 Merial Limited, Duluth, GA. All rights reserved. EQUIUGD1222 (04/12)
1 Animal Health Institute, American Veterinary Medical Association, American Veterinary Distributors Association. Veterinary Compounding. Available at: http://www.aaep.org/siteadmin/modules/page_editor/images/files/AHI%20Compounding.pdf. Accessed April 4, 2012.
2 Medical Portal. Animal Drug Approval Process. Available at: http://www.dawnbreaker.com/portals/medicalportal/veterinary/drugapproval.
Php. Accessed April 4, 2012.
3 U.S. Department of Health & Human Services. FDA’s role in animal health. Available at: http://www.fda.gov/AnimalVeterinary/NewsEvents/FDAVeterinarianNewsletter/
ucm235765.htm. Accessed April 5, 2012.
4 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.
5 Omeprazole Direct Website. http://equine.omeprazoledirect.com/. 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.