FDA Issues Warning Letters Concerning Unapproved Omeprazole

The U.S. Food and Drug Administration has issued nine warning letters to companies marketing unapproved animal drugs containing omeprazole.
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FDA testing revealed that several of these products contained higher or lower levels of omeprazole than stated on their labels.

The U.S. Food and Drug Administration has issued nine warning letters to companies marketing unapproved animal drugs containing omeprazole. These products have not been reviewed by the FDA for safety and effectiveness. FDA testing also 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 only FDA-approved animal drugs containing omeprazole are GastroGard (NADA 141-123) and UlcerGard (NADA 141-227). These products are approved for the treatment and/or prevention of gastric ulcers in horses.

FDA has serious concerns about unapproved animal drugs. Unapproved animal drugs have not been reviewed by FDA and may not meet FDA's strict standards for safety and effectiveness. They also may not be properly manufactured or labeled. FDA advises horse owners and caretakers to avoid using unapproved animal health drug products, including omeprazole products. Horse owners or caretakers should consult with their veterinarians about safe and effective therapies for the prevention and/or treatment of gastric ulcers.

FDA issues warning letters to companies marketing the following unapproved omeprazole products:

If the companies that were issued the warning letters continue to market violative products, they may be subject to enforcement action, including seizure of violative products and/or an injunction.

Horse owners, caretakers and veterinarians should report to the FDA any adverse events, including ineffectiveness, in horses that received unapproved omeprazole products. Information on reporting adverse events for approved or unapproved animal drugs can be found at the UDSA website.

Complaints about approved and unapproved animal drug products can be reported by calling a consumer complaint coordinator within your FDA district office or by filing a Veterinary Adverse Drug Reaction report.

Horse owners, caretakers and veterinarians who purchased these unapproved omeprazole products should work directly with the retailer regarding refunds or other compensation.

Additional Information

Follow this link for more information on FDA's concerns regarding unapproved drugs. 

Information on how to tell if a drug is FDA-approved for animals 

From an Idea to the Marketplace: The Journey of an Animal Drug through the Approval Process 

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