FDA Issues Warning About Several Gastric Ulcer Products

As we’ve told you in our initial news story and Dr. Deb Eldredge’s blog, the FDA has warned several companies with products they claim treat ulcers. The products are:

An equine ulcer. Looks painful, doesn’t it?
  • AbGard
  • Abler Omeprazole
  • Abprazole
  • Abprazole Plus
  • Gastro 37 OTC
  • Gastroade Xtra
  • GastroMax 3 (marketed by Horse Gold, Inc. and Horse PreRace)
  • Gastrotec (marketed by Horse Prerace and Tri-Star Equine Marketing, LLC)
  • Lomac Equine
  • Omaktive Oral Paste
  • Omeprazole Oral Paste
  • Omeprazole/Ranitidine Oral Paste
  • Omoguard Paste
  • UlcerCure OTC

So, why am I talking about this again? Because I believe equine health is at stake here and many horse owners do not fully understand the point of the warnings. 

First, as most of us know, the FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. That’s an important job.

In this particular incident, the FDA revealed that several of these products contained higher or lower levels of omeprazole than stated on their labels, ranging from as little as 36.3% to as much as 135% of the level claimed on the label.” The statement goes on to say, “FDA has serious concerns about unapproved animal drugs. They may not be properly manufactured or labeled. Horse owners and caretakers are advised to avoid using unapproved animal drug products, including omeprazole products.”

We’ve heard grumblings from consumers believing the FDA just targeted those particular companies for hidden reasons and/or that Merial, the maker of the only FDA-approved equine gastric ulcer medications, was behind the warning. However, these beliefs are misguided.

The use of medications that are not FDA-approved is risky. Remember our articles about compounding pharmacies? We believe it’s risky and not worth your time or money to use drugs from compounding pharmacies. And, given that some of these products involved in the FDA warning are inconsistent with their dose strength, their use would subject your horse to a roller coaster of medication doses. Usually, horses given non-FDA approved medications wind up receiving subtherapeutic doses, which not only equates to dollars being tossed into the manure pile, but also can confuse owners as to what is actually going on with their horse.

Consider this: if your horse shows signs of gastric ulcers, you would expect that giving the horse an omeprazole anti-ulcer medication would cause a resolution of those signs. But if you use a product that is not true to its label, you may end up mistakenly concluding that the cause of your horse’s problems are not gastric ulcers… when in fact they actually are. This is probably the biggest factor weighing into why use of non-FDA approved products results in harm to horses.

With the problem of equine ulcers becoming increasingly familiar to horse owners and veterinarians, the use of ulcer medication is likely to become more prevalent.

There are two FDA approved anti-ulcer formulations on the market. Both manufactured and marketed by Merial, Gastrogard and Ulcergard may be given at varying doses on a daily basis. They both actually contain the exact same contents: each tube consists of 2.28 grams of omeprazole paste. The difference is that Gastrogard has been approved by the FDA to be marketed as a prescription product to use for the treatment of diagnosed gastric ulcers. Ulcergard, on the other hand, has been approved for marketing as an over-the-counter product for use in preventing gastric ulcers. Other than their labels, there are no differences between the two products.

But what makes these products so special? What they have that the others lack boils down to a few critical elements:

1. They are FDA approved. This means that they have been rigorously tested for safety, efficacy and accuracy of label claims.

2. The chemical make-up of Gastrogard and Ulcergard renders them much more usable by the body. Most folks assume that because gastric ulcers are occurring in the stomach, that the medications work once they are in the stomach. This is inaccurate. The medications must pass through the stomach and into the small intestine where they can then be absorbed into the bloodstream. Once in the blood, they travel to the stomach from the other side of the wall and act to shut off the hydrogen proton pumps that create stomach acid. The key to the product success relies partly on the omeprazole being able to pass through the stomach without being denatured by the acid. To accomplish this, the drug manufacturer enterically coats the medication.

Take home point: The copy-cat medications are not enterically coated in most cases, rendering them susceptible to digestion by stomach acid. End result: your money being wasted and your horse not getting the treatment he needs.

Make life easy on yourself and your horse! Use FDA-approved medications and work with your veterinarian to determine an appropriate dose.  Beware of compounded drugs!

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