HorsesDaily: Don't Use Knock-Off Versions of Medications Or Your Horse Will Be The Victim

Don't Use Knock-Off Versions of Medications Or Your Horse Will Be The Victim

Compounded Omeprazole To Treat Equine Ulcers Provides Substandard Results

Unsuspecting horse people have had the wool pulled over their eyes in recent months as the victims of pharmacies who are illegally producing compounded omeprazole for horses with ulcers. Compounded products provided substandard results and the horses using it have continued to suffer. So horse lovers, owners, trainers, and veterinarians beware! GASTROGARDO is the only FDA-approved product proven to heal, treat, and prevent the recurrence of ulcers in horses.

HELP FOR ULCERS
When Merial, the makers of GastroGard, realized that ulcers were a problem in horses (studies have shown that as many as 1.8 million horses in the U.S. have ulcers), they decided to go the extra mile and develop a product that would weather the high standards of horsemen. Not only did they come up with this product but they went through the time, effort, and expense of getting it tested and approved by the FDA so that horse people could feel confident that GastroGard did what it was touted to do. In fact, since its introduction, horse people have praised the results and overall improvement of their horses' appearance and overall health.

GASTROGARD AT A CHEAPER PRICE? NOT TRUE!
Focusing only on the bottom line, some horse people have administered compounded omeprazole to their horses, because they heard it was just as good as GastroGard, but available at a cheaper price. In fact, nothing could be further from the truth and it is the horses that have become the victims of these inferior products. Dr. Orsini, Associate Professor of Surgery at New Bolton Center at the University of Pennsylvania, has done a number of studies to test the effectiveness of GastroGard. He has also had the opportunity to use an endoscopic device to look at the stomachs of horses with Equine Gastric Ulcer Syndrome (EGUS) that were being treated with compounded omeprazole and he has seen substandard results. "I've seen enough horses on the compounded omeprazole to know that it is ineffective at treating horses with ulcers." Cynthia Kollias-Baker, DVM, PhD, DACVCP, Assistant Professor of Clinical Equine Pharmacology of the University of California noted, "Product absorption is really crucial for omeprazole in particular. If the product isn't absorbed, it can't be effective. Compounded products may be cheaper, but they are not effective. So you are spending less, but you are not effectively treating the horse for gastric ulcer disease. Therefore, the price savings are irrelevant."

WHAT IS COMPOUNDING?
To compound a medication means to combine a few ingredients together to develop an agent. Consequently, when pharmacists are compounding ulcer medications to mimic the effects of GastroGard, they use omeprazole, the active ingredient in both GastroGard and the human medication PrilosecO. The omeprazole is the active ingredient that effectively eliminates the production of excess acid, allows ulcers to heal, and helps patients return to peak health. Although these products contain some omeprazole, the chemical formulation is different and therefore the healing results are not the same. The omeprazole used in GastroGard is calibrated to work specifically in horses. The chemical composition and paste formulation have been tested and clinically proven to heal, treat, and prevent the recurrence of ulcers in horses. Clinical analyses have shown compounded omeprazole products to contain as little as 6% of their labeled values. This lack of active ingredient renders them virtually useless in the treatment of EGUS. In the end, the horses still continue to suffer the pain and side effects of ulcers, such as mild-to-severe colic; poor appetite; changes in eating habits; weight loss; inconsistent training; decreased or poor performance or unwillingness to perform; irritability; attitude or personality changes; poor body condition; tucked-up appearance; and dull, poor, or rough hair coats.

COMPOUNDED PRODUCTS OFFER NO GUARANTEES
It has been proven that in compounded products the quality, purity, and potency of the bulk ingredients cannot be assured and the measurement of active ingredient may vary from dose to dose. Also, the shelf life of these products is undetermined, the bioavailability of the compound may be inhibited, and the formulations may be unstable. Added to that is the fact that the FDA has determined that there "is a potential of causing harm to . animals when drug products are compounded, distributed, and used in the absence of adequate and well-controlled safety and efficacy data, adherence to the principles of contemporary pharmaceutical chemistry and current good manufacturing practices." Beyond the issue of having enough of the active ingredient in compounded omeprazole is the importance of bioavailability, meaning what quantity of the compound goes from the horse's stomach to its bloodstream. Omeprazole breaks down very rapidly when it comes in contact with stomach acid; consequently, it must be formulated to protect the compound as it moves through the stomach. The sophisticated and patented formulation process is expensive because of the rigorous testing done to ensure its effectiveness. GastroGard was developed using these stringent quality-control standards. Since compounded products don't undergo a rigorous formulation-development program, there is no guarantee of their usefulness or safety in the treatment of equine gastric ulcers. Dr. Baker, who is very concerned about the use of any compounded product, is especially worried about compounded omeprazole. "Absorption is really a problem with omeprazole. It is very acid labile. So it is destroyed quite easily in the stomach." Dr. Baker has been involved in a research project to look at the absorption of omeprazole; the study is comparing GastroGard to compounded omeprazole products. "Merial has developed a sophisticated formulation allowing this product to be absorbed in significant degrees by the horse. It doesn't work by being administered into the stomach like an antacid; it has to be absorbed in the gastrointestinal tract-compounded formulations aren't able to master that patented technology." Dr. Baker went on to explain that the preliminary results from the study have shown that "the compounded product is very poorly absorbed, basically only detectable in 50% of the horses' studied for one hour and the GastroGard was readily detected in 100% of the horses serum for a number of hours."

DON'T COMPROMISE YOUR HORSE'S HEALTH
"Veterinarians are responsible for what we dispense. If the formulation for these compounded products are so variable, there is no quality control and we have no way of knowing how much of the active ingredient that particular horse is actually getting, then we are doing a disservice to the horse, trainer and owner. If you had to pick out one reason why I wouldn't use compounded omeprazole it would be because I know it doesn't work," remarked Dr. Orsini. Dr. Orsini concluded, "I know that many people use compounded omeprazole because they think they are saving money but you must think about the time that is lost because the horse doesn't respond to the ulcer medication; so they are still eating and/or training poorly and they are losing weight. That money that you appear to be saving up front you are really paying for in the end. I understand that there are cost concerns when treating equine gastric ulcers properly, but when a medication goes over all the different hurdles to get FDA approval, you can be certain you are using the best drug available to treat the ulcers. And that's really the bottom line."