FDA Warnings On Ulcer Drugs

What does this mean to the consumer?
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What does this mean to the consumer?
UlcerGard is available without a prescription. GastrGard requires a prescription. Both are FDA-approved for the treatment of ulcers.

UlcerGard is available without a prescription. GastrGard requires a prescription. Both are FDA-approved for the treatment of ulcers.

As of today, November 12, 2014, the U.S. Food and Drug Administration (FDA) has sent out letters of warning to a number of companies about unapproved drugs that contain omeprazole and are being marketed for horses. Omeprazole is most commonly used in the treatment of and prevention of gastric ulcers in horses. 

These particular versions of the drug have not gone through safety and efficacy testing that the FDA requires. In addition, the FDA’s own testing showed that some versions did not contain the stated amount of omeprazole. Some were under (as little as 36% of the drug present) and some were over (up to 135 % of the drug found). 

The only FDA-approved versions of omeprazole for horses at this time are GastroGard and UlcerGard, both manufactured by Merial.

Products covered in the warning letter include: AbGard, Abler Omeprazole, Abprazole, Abprazole Plus, Gastro 37 OTC, Gastroade Xtra, GastroMax 3, Gastroted, Lomac Equine, Omaktive Oral Paste, Omeprazole Ranitidine Paste, Omoguard Paste, UlcerCure OTC and Omeprazole Oral Paste. We think these products should be voluntarily removed from the market. If we were consumers who purchased these medications, we would consult with the retailer where they were purchased about possible refunds. 

As always, any complaints about animal medications can be made to the FDA by contacting a consumer complaint coordinator or filing a report using the Veterinary Adverse Drug Reaction form. You do not have to be a veterinarian to do so. 

We all like to complain quite loudly about the FDA – wishing they would approve drugs we want for our horses faster, wishing they would lighten up on requirements for drug approvals, etc. This case demonstrates why our system of drug approval with the FDA works. 

Yes, all the products tested contained a drug that is approved for ulcers – one that we know helps horses with gastric ulcers or a tendency to develop ulcers in certain situations. BUT, the FDA states these companies did not go through the required procedures to market the products as drugs, and the actual amount of medication found in some of these products did not match the label. 

If your horse has liver disease, giving what amounts to an overdose of omeprazole could cause some problems. If your horse is taking omeprazole to help counter side effects of NSAIDs (nonsteroidal anti-inflammatory drugs) and he is not actually getting the full amount prescribed, you could, again, have problems as the lower amount may not be effective. 

The FDA looks at a variety of areas before doing a recall. There may be adulteration problems – something in the medication that does not belong there. This could be a chemical contaminant or a biological one. The formulation may not be correct (and that would include not having the specified amount of medication present in the product). 

Depending on the exact situation, I wouldn't be surprised if an official recall is sent out. However, the most serious recalls are for products that have the potential to cause serious health problems or even death. Less serious are for products that have a low likelihood of causing a health problem or are only going to cause temporary/reversible problems. Least serious are products that aren’t going to cause any adverse health problems but don’t work or are misleading. 

So while we do grump about the FDA at times, we should also thank them for keeping our horses (and our food supply and our own medications) safe.