FDA Targets Unlicensed Horse Drugs

The FDA has warned online sellers of what the agency says are unlicensed and adulterated horse drugs, including ulcer treatments containing omeprazole.
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The FDA has warned online sellers of what the agency says are unlicensed and adulterated horse drugs, including ulcer treatments containing omeprazole. | © Charles Mann/cmannphoto.com

The FDA has warned online sellers of what the agency says are unlicensed and adulterated horse drugs, including ulcer treatments containing omeprazole. | © Charles Mann/cmannphoto.com

Treating a horse for gastric ulcers is costly. You’ll pay up to $34 a tube for GastroGard (Merial), the approved medication, and that tube might last two days depending on your horse’s size. Can you find cheaper alternatives online? Sure. But the Internet is a pharmaceutical Wild West, and you might not get what you pay for. 

The U.S. Food and Drug Administration has been cracking down on online sellers of what the agency says are unlicensed and adulterated horse drugs, including ulcer treatments containing omeprazole, the active ingredient in GastroGard. Last fall the FDA sent warning letters to nine such marketers: 

• Cox Veterinary Laboratory, Chester, South Carolina (seller of Gastroade Xtra)

• Horse Gold, Wellington, Florida (GastroMax3)

• Horse PreRace, Orlando, Florida (Omeprazole Oral Paste, Omeprazole/Ranitidine Oral Paste, Gastrotec, GastroMax3)

• Multivet USA, Stony Point, New York (Gastro37 OTC)

• Tri-Star Equine Marketing, Delray Beach, Florida (Gastrotec)

• Ulcercureotc.com, Pleasant Grove, Utah (UlcerCure OTC)

• Abler Inc., NSW Australia (AbGard, Abprazole, Abprazole Plus, Abler Omeprazole and other medications)

• Genericfrontlineplus.com, Dubai (Lomac Equine and Omaktive Oral Paste)

• Nature Vet (CEVA Animal Health), NSW Australia (Omoguard Paste)

Under U.S. law (specifically, the Federal Food, Drug and Cosmetic Act), any product that is sold “to mitigate, treat or prevent disease in animals” is considered a drug and must be approved by the FDA. When drugs have not gone through the approval process, there’s no way to know if they’re safe and effective—so the law considers any unapproved drug “unsafe and adulterated.” 

In addition, samples of some ulcer medications tested by the FDA (AbGuard, Gastroade Xtra, Omeprazole Oral Paste, UlcerCure OTC) didn’t contain the amounts of omeprazole listed on their labels. The Gastroade Xtra sample contained just 36.3 percent of the label claim, the FDA said. The marketers were given 15 working days to respond and outline corrective action. 

Shepherding a new drug through the approval process is a long and costly process, and that factors into the price of name-brand approved medications. In exchange for paying that price, you get assurance that the drug is and does what the label says, safely. You don’t get that assurance with an unapproved medication, which may or may not be as helpful as the licensed drug even when it contains the same active ingredients. (A study carried out several years ago found that a compounded medication containing the same omeprazole dose as GastroGard was not nearly as effective, suggesting that the medium that carries the drug makes a difference.) 

A drug company that gets a new animal drug approved by FDA gets marketing exclusivity for a limited time. That period has expired for GastroGard (and in the ulcer preventive UlcerGard, also made by Merial), and the drug’s patent expires this spring. But that doesn’t mean you can rely on any alternative that pops up. 

Generic horse drugs, like all animal drugs, have to win FDA approval to be legally sold in the United States. The process is shorter than for a new drug, but the maker must show that the generic is

• identical to the approved drug in active ingredients, strength and dosage form and regimen; 

• consistently made from batch to batch, and 

• bioequivalent to the approved drug, meaning that it’s absorbed by the animal’s body and acts the same way in it.

If you’re shopping for a cheap alternative for any medication, then, hold out for an approved generic.

This article originally appeared in the February 2015 issue of Practical Horseman.

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