FDA Issues Warning Letters for Unapproved Omeprazole Drugs Marketed for Use in Horses
November 12, 2014
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 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 issued warning letters to companies marketing the following unapproved omeprazole products:
AbGard
Abler Omeprazole
Abprazole
Abprazole Plus
Gastro 37 OTC
Gastroade Xtra
GastroMax 3 (marketed by Horse Gold, Inc.) (marketed by Horse PreRace)
Gastrotec (marketed by Horse PreRace) (marketed by Tri-Star Equine Marketing, LLC)
Lomac Equine
Omaktive Oral Paste
Omeprazole Oral Paste
Omeprazole/Ranitidine Oral Paste
Omoguard Paste
UlcerCure OTC
If the companies that were issued the warning letters continue to market the violative products, they may be subject to enforcement action, including seizure of violative products and/or an injunction.
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