Ulcer Prevention Drug Approved By FDA

Horse owners will be able to prevent painful gastric ulcers in their horses with a new omeprazole product that has just been approved for equine use by the Food and Drug Administration (FDA). The product will be available through veterinarians without a prescription, and it has been shown to effectively prevent ulcers in horses when given for 28 days during the time of stressful activities.

Merial pharmaceutical company sought approval for the new drug, UlcerGard, after studies last year showed that one-fourth of a treatment dose (1 mg/kg) of its ulcer treatment drug GastroGard (omeprazole) effectively prevented ulcer formation in horses. It had already been shown that half the treatment dose could prevent recurrence of ulcers, but with this new discovery, the company decided it could make ulcer prevention more easily available and the dosing of the compound more user-friendly.

According to Merial, studies have shown that more than 90% of racehorses and more than 60% of non-racing competitive horses have experienced equine gastric ulcer syndrome (EGUS). Changes in routine, diet, and exercise regimen that come with confinement, training, travel, and performance might contribute to the development of gastric ulcers. Clinical signs include weight loss, altered eating behavior, recurrent colic, change in attitude or disposition, sub-optimal performance, diarrhea, and/or a dull coat.

Stephanie Thompson, DVM, manager of Merial Veterinary Technical Services, said, "GastroGard was designed for the treatment of ulcers. UlcerGard was developed for the prevention of ulcer occurrence. Both products are easy to use, well-accepted by horses, and have been proven to work."

She explained that in order to get the label claim for prevention of ulcers, the company had to go back and perform the aforementioned studies to prove its efficacy for that purpose (for more information, see www.TheHorse.com/ViewArticle.aspx?id=5001).

It's important to determine that the horse doesn't have ulcers (via veterinary endoscope) before beginning the 28-day UlcerGard regimen. "If you have a horse that you know has ulcers or suspect has ulcers, consult with your veterinarian," said Thompson. "A horse might be diagnosed with ulcers and need to be treated with GastroGard first to ensure that the ulcers have healed. A lot of those horses will be in stressful situations, and we know there's a chance the ulcers could come back again. Many of these horses will be very good candidates to put on UlcerGard."

During the UlcerGard regimen, the horse will receive one 1 mg/kg dose of omeprazole per day in an oral paste. Each syringe of UlcerGard contains four preventive doses with a total of 2.28 g of omeprazole for horses weighing 600 pounds or more. Two doses are recommended for horses that weigh more than 1,200 pounds. Thompson said that the dosing of UlcerGard is more user-friendly than giving partial doses of GastroGard as a preventive treatment, and that anyone at the barn should be able to give an accurate dose. The medication is cinnamon-flavored and reportedly is well-accepted by horses. UlcerGard should cost the horse owner less than $10 a day (private practitioners have said that treatment doses of GastroGard vary from $60 to 80 a day).

"Both products are available through the veterinarian, but the big thing is that the UlcerGard doesn't require a diagnosis," said Thompson. "Veterinarians play a crucial role in any preventive maintenance program for horses and are the ones that give you the best advice on how to use this type of product," which explains why Merial is requiring that the product be distributed through veterinarians.

If your horse is under year-round stress and you are concerned about taking him off UlcerGard after a 28-day course, you should consult your veterinarian. Historically, omeprazole has been shown to be very safe at ulcer treatment levels.

Thompson said, "Treating ulcers is going to cost you a whole lot more than preventing them. Gastric ulcers are a very painful condition, and you find a lot of times that the horses aren't performing up to the level that you would expect them to. With UlcerGard, we will be able to prevent those painful ulcers from occurring."

About the Author

Stephanie L. Church, Editor-in-Chief

Stephanie L. Church, Editor-in-Chief, received a B.A. in Journalism and Equestrian Studies from Averett College in Danville, Virginia. A Pony Club and 4-H graduate, her background is in eventing, and she is schooling her recently retired Thoroughbred racehorse, Happy, toward a career in that discipline. She also enjoys traveling, photography, cycling, and cooking in her free time.

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