Compounded Ulcer Products: Buyer Beware

Scientists are warning horse owners and veterinarians to be cautious of compounded (private pharmacy-mixed) gastric ulcer medications. One study showed that a compounded product was not absorbed very well, while another researcher warned against possible problems with the shelf life of compounded ulcer medications. The compounded ulcer drugs are being marketed as being as effective in treating ulcers as the FDA-approved product omeprazole (sold under the brand name GastroGard), which costs more.

Cynthia Kollias-Baker, DVM, PhD, Dipl. ACVCP, Assistant Professor of Equine Clinical Pharmacology at the California Veterinary Diagnostic Laboratory System at the University of California, Davis, recently completed studies comparing omeprazole to compounded gastric ulcer medications. She became interested in the issue when asked by clinics whether a compounded product could be used interchangeably with omeprazole. She predicted that the compounded drug was not being absorbed and utilized, and her research upheld her theory.

She found that omeprazole was readily detected in the bloodstream for eight to 12 hours after administration of the drug. The liquid compounded product was only detectable once, at seven hours after administration. "The levels of omeprazole were well over 200 nanograms/mL, whereas in the compounded horses (the level was) only 30 nanograms/mL in the one hour it was detectable," she said.

James Orsini, DVM, Dipl. ACVS, Associate Professor of Surgery at University of Pennsylvania's New Bolton Center, who has done extensive research on gastric ulcers, explained that the FDA's role is to make sure that drugs meet the specifications for which they are marketed. Every state has a board of pharmacy that oversees these issues--if there are concerns about ineffectiveness of a compounded product, the state board should be called. Another concern about using the compounded drugs is that the shelf life of these products is highly variable, as is the concentration of the drug in each batch.

"Based on what we know of the equine gastric ulcer syndrome, these animals (receiving compounded drugs) can have further performance problems, eat poorly, and lose weight, which are signs and symptoms of the disease," Orisini explained. He added that compounded drugs have a definite place in equine veterinary use. Baker agreed, saying, "It's unfortunate to see the process abused. The end result would be that we could lose the privilege to use it."

About the Author

Stephanie L. Church, Editor-in-Chief

Stephanie L. Church, Editor-in-Chief, received a B.A. in Journalism and Equestrian Studies from Averett College in Danville, Virginia. A Pony Club and 4-H graduate, her background is in eventing, and she is schooling her recently retired Thoroughbred racehorse, Happy, toward a career in that discipline. She also enjoys traveling, photography, cycling, and cooking in her free time.

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