On November 12, 2014, the U.S. Food and Drug Administration (FDA) released information that warning letters had been issued to companies for marketing unapproved animal drugs. The focus of the letters is on omeprazole, a drug intended for equine use in the treatment of gastric ulcers.

Warnings
The FDA revealed that the warnings were issued because the products:

• Have not been reviewed for safety and effectiveness
• Contained varied levels of omeprazole

When compared to the label information, FDA testing found that the products actually contained levels that ranged from 36.3 percent to 135 percent of the amount claimed on the label.
In their statement, the FDA expressed concern that since these animal drugs have not been reviewed, they may not meet the standards set for safety and effectiveness. As found when testing for the levels of omeprazole, unapproved animal drugs may not be properly labeled or manufactured. The FDA warns that these unapproved animal drug products should be avoided, and companies who continue to market the unapproved products may be subject to enforcement action that could include seizure of products or injunction.

Unapproved Omeprazole Products
As listed in the FDA-issued statement, unapproved omeprazole products include:

• 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

Reporting Information
The FDA is asking that veterinarians, horse owners, and caretakers report any issues observed in horses that have received these products. The website to report this information can be found at:
http://www.fda.gov/animalveterinary/safetyhealth/reportaproblem/ucm055305.htm.

FDA District Office Information
Efforts to return purchased unapproved omeprazole products should be worked out with the retailer. Complaints can be reported to a FDA District office consumer complaint coordinator or by filing a Veterinary Adverse Drug Reaction report. The information for local district offices can be found at: http://www.hhs.gov/about/regions/fdacer.html.

FDA-Approved Omeprazole
At this time there are only two FDA-approved animal drugs containing omeprazole that are used for the treatment and/or prevention of gastric ulcers in horses. They are:

• GastroGard (NADA 141-123)
• UlcerGard (NADA 141-227)

The information detailing the issuance of the FDA warning letter can be found at: http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm422694.htm.