FDA-Approved Equine Medications Provide Peace of Mind

April Knudson, DVM, is an equine specialist with Merial Veterinary Services. She has a special interest in equine gastrointestinal health, infectious disease, and lameness. Here, she answers a question about the importance of using equine drugs that have been approved by the U.S. Food and Drug Administration (FDA).

Question: I've heard I should only use drugs that have been approved by the FDA. Why is that important?

Answer: That's a great question, because with all the drugs and products available to horse owners, sorting through them can be a challenge. Should you choose based on price, your trainer's suggestion or maybe what worked for a friend's horse?

While these might be used as secondary considerations, none of them should drive your decision when selecting a drug to give to your horse. Instead, that decision should be made based upon your veterinarian's recommendation and whether or not the product has been approved by the FDA.

Drugs approved by the FDA can provide horse owners with the peace of mind that they have been thoroughly tested for both safety and efficacy. So what does that mean to the health of your horse?

During a new drug's development phase, the company bringing it to market conducts tests to demonstrate the safety of the proposed product in the target animal. Tests are also conducted to confirm the efficacy of a product. When the labeling and subsequent advertising are developed, the FDA regulates what claims can and can't be included. The FDA's stringent labeling guidelines help ensure product claims are fair and accurate and that horse owners will be aware of any possible risks associated with the product.

After a drug is approved by the FDA and available on the market, the agency continues to monitor it, including any adverse events that might occur. This helps identify any problems that arise and enables companies to address them quickly.

Some drugs are produced and marketed to horse owners that are not FDA-approved, and therefore have not undergone safety and efficacy testing. In some instances, these products make claims that have not been proven. Examples of products being falsely marketed are any that advertise themselves to be the equivalent of UlcerGard or GastroGard, which are the only FDA-approved products for the prevention and treatment of equine stomach ulcers. Taking chances with any product that has not been FDA-approved and therefore does not necessarily meet safety and efficacy standards means your horse could continue to suffer and you could be wasting money.

So how can you tell if a product has FDA approval and adheres to its stringent guidelines? Look for the six-digit New Animal Drug Application (NADA) number, or in the case of generics, find the Abbreviated New Animal Drug Application (ANADA) number, on the label. Or you can look up the drug in the searchable database at AnimalDrugs@FDA.

Remember, if you have any doubts, consult your veterinarian.

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