Help ensure safety, product performance by demanding FDA-approved products
DULUTH, GA — March 10, 2010 — When your horse’s health — and your dollar — are on the line, using products that carry the stamp of the Food and Drug Administration (FDA) approval is a surefire way to ensure it has been tested for safety and effectiveness.
“Taking chances with products that aren’t FDA-approved means you may have to go back to the drawing board for a real solution. Or worse, you could even be putting your horse’s health at risk,” says Hoyt Cheramie, DVM, MS, manager, Veterinary Services, Merial. “Some horse owners may even believe that they are receiving FDA-approved products when, in fact, they may be paying for an illegally compounded product.”
This includes products claiming to treat or prevent equine stomach ulcers, Dr. Cheramie says. Because there are FDA-approved products, compounding pharmacies that offer stomach ulcer treatment or prevention may be producing an illegal product.1
In a recent open letter to veterinarians regarding another equine medication, the FDA noted the presence of FDA-approved products greatly reduces the need for compounding, which may be reserved for specific patients requiring a strength or dosage form not available.2
In prescribing an FDA-approved product, “you are providing your clients and their horses with a drug that has demonstrated safety and effectiveness in horses and whose manufacturing process met the FDA’s standards for quality, purity, and potency,” the FDA letter stated.2
This letter was an excellent reminder of the exacting standards the FDA and manufacturers take to ensure a product’s safety and effectiveness, Dr. Cheramie says. Owners may not be aware of the standards in place to help protect them, and their horses.
Compounded omeprazoles may lack the consistency and effectiveness of FDA-approved products,3,4 and, therefore, owners using compounded omeprazole may not be addressing their horse’s health concern, Dr. Cheramie says.
In a study, administration of compounded omeprazole suspension was ineffective in healing stomach ulcers in horses.3 However, the FDA-approved product, GASTROGARD® (omeprazole), was effective in the same study.
Compounded omeprazole products may not even contain the labeled value of active ingredient. In a comparison of 10 compounded omeprazole products, the value of omeprazole ranged from 6 percent to 76 percent of their labeled values.4
“Stomach ulcers can develop in a range of situations — from competition,5 to changes in routine6 — but the heart of the problem is acid production, and there are only two FDA-approved products proven to consistently and effectively suppress acid production at the acid pump for either prevention or treatment of stomach ulcers,” Dr. Cheramie says.
ULCERGARD® (omeprazole) is the only FDA-approved product to prevent stomach ulcers*, and GASTROGARD is the only FDA-approved product to heal stomach ulcers. The unique, patented formulation of the products helps ensure the omeprazole is stabilized to work effectively. While the products are dosed differently to either provide prevention or healing, both offer convenient once-daily administration that is well accepted by horses.5,7
“Choosing products that are FDA-approved helps ensure that you’re not only providing the best medicine for your horses, but that you’re also making the most of every equine healthcare dollar,” Dr. Cheramie says. “Don’t take chances with horses’ health. Look for FDA-approved products that are proven safe and effective.”
Merial is a world-leading, innovation-driven animal health company, providing a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals. Merial employs approximately 5,700 people and operates in more than 150 countries worldwide. Its 2008 sales were over $2.6 billion. Merial is the Animal Health subsidiary of sanofi-aventis. For more information, please see www.merial.com.
IMPORTANT SAFETY INFORMATION: The 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.