FDA Approves Anti-Ulcer Medication For Use In Horses

Merial, a Merck and Rhone-Poulenc company, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Gastroguard (omeprazole) Paste, the first and only prescription medication approved by the FDA to heal and prevent the recurrence of stomach ulcers in horses. Omeprazole is the same active ingredient found in Prilosec the world's leading anti-ulcer medication for humans.

"Only recently, with advances in diagnostic testing, has the seriousness of Equine Gastric Ulcer Syndrome (EGUS) been understood and until now, there was no approved medicine specifically designed for treating ulcers in horses," said Dr. Frank Andrews, associate professor and section chief, Large Animal Medicine, University of Tennessee College of Veterinary Medicine, Knoxville, Tenn. "Gastroguard is an important new drug because it is the first medication that has been proven to heal stomach ulcers and, just as significantly, can prevent them from recurring even while the horse is still in training. This drug will have a significant impact on the equine industry."

Gastroguard was granted accelerated review by the FDA because the molecule was new to veterinary medicine and had potential therapeutic value for an important, often serious condition. EGUS may affect as many as 1.8 million U.S. performance horses. Recent studies have shown that EGUS affects up to 93 percent of racehorses, almost 60 percent of other performance horses and up to 57 percent of foals (horses under the age of one year). Gastroguard will be available from veterinarians in two weeks.

Like People, Horses Get Ulcers, Too
As with human ulcers, stomach acid appears to be the main cause of horse ulcers. Excess acid can eat through the protective lining and damage the stomach. Among the most noticeable signs of ulcers are decreased appetite, colic, poor hair coat, poor body condition and poor performance. In foals, clinical signs may include grinding of teeth, colic, intermittent nursing, decreased appetite and weakness.

Feeding practices, training and trailering, competing, and even hospitalization can contribute to ulcer formation in horses. Intensity of training may also contribute to ulcer formation. "Helicobacter pylori," bacteria that are a factor in the development of human ulcers, have not been isolated from horse stomachs and are not currently considered to be a cause of horse ulcers.

"Gastric ulcers are very common in adult horses as well as foals. Symptoms of ulcers are often not apparent because our patients can't talk to tell us they are uncomfortable," said Dr. Michael J. Murray, associate professor and Adelaide C. Riggs Chair in Equine Medicine, Marion duPont Scott Equine Medical Center, Virginia-Maryland Regional College of Veterinary Medicine, Leesburg, Va. "In most cases, foals and horses exhibit signs of ulcers in ways that can be missed or misunderstood, and an owner or trainer may not recognize that there is a problem unless the horse shows overt signs of colic."

Gastroguard Contains Same Ingredient as Prilosec, an Anti-Ulcer Drug for Humans
The active ingredient in Gastroguard is omeprazole—the same compound as in Prilosec—the world's No. 1 anti-ulcer medication for humans and the No. 1 selling prescription drug in the world.

"In the past, many different medications used to treat heartburn and stomach ulcers in humans have been used by veterinarians to treat horses," said Dr. Nicholas Vatistas, department of veterinary surgical and radiological sciences, University of California, Davis, Calif. "This is a common and accepted practice. Unfortunately, many of these medications had variable results, even at high doses, and had no recommended dose or administration schedule proven through controlled research studies. Often, treatment required that the horse be removed from training."

None of these medications have been evaluated or approved for use in horses by the FDA, and their safety in horses has not been assessed.

For more information on Gastroguard and Equine Gastric Ulcer Syndrome, visit the www.gastrogard.com and www.egus.org, or call toll-free, 877-GASTROGARD or 877/427-8764.

Full prescribing information available at www.gastrogard.com.

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