On Nov. 12, the U.S. Food and Drug Administration announced it issued nine warning letters to companies marketing and selling unapproved medications containing omeprazole. All of the FDA-unapproved drugs in question state they cure, prevent or treat equine gastric ulcer syndrome.

“These products have not been reviewed by the FDA for safety and effectiveness,” stated an FDA release. “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 percent to as much as 135 percent of the level claimed on the label.”

Currently the only FDA-approved equine drugs containing omeprazol are GastroGard and UlcerGard.

FDA issued the 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. 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

The companies were found in violation since their drugs don’t have FDA approval, conditional approval and are also not index listed. The companies whose actual active ingredient percentage didn’t correspond with the label amount were also cited for that. They all have 15 working days from Nov. 12 to comply with the FDA’s requests.

“Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products,” stated the FDA’s letters.

“If there’s an active ingredient drug ingredient, [the companies] do need to go through the FDA approval process,” said FDA press officer Megan Bensette. “We put this out to let people know that these products are worrisome.

“The FDA receives information on unapproved drug products through a variety of sources including: consumer and industry complaints, trade associations, FDA district offices and regulatory counterparts in other government agencies, to name just a few,” she added. “In this case, we received complaints from more than one source.”

You can see the FDA release and all of the letters sent to companies on the FDA website. There is also additional information on what FDA classifies as a drug.