Safety and Efficacy of Compounded Medication

The FDA recently recalled another unapproved omeprazole product. While there are plenty of reasons to be annoyed with the inefficiencies of the FDA, because we all want faster, safer medications for our horses, we do need to remember the importance of the role the FDA plays. It’s important to know the facts about legitimate and illegitimate compounded drugs in order to best care for your horse. 

Compounding is the process of customizing a drug for a horse when a commercially available one does not already exist. This is a necessity to meet the therapeutic goals for a horse’s health, and is important for successful veterinary care. Because there is a scarcity of approved medications for horses, compounded medication is an important part of equine health.

In order to regulate the industry of compounded drugs, only a licensed veterinarian can legally write a prescription for a compounded drug, and only when an FDA approved drug is not already available.

Illegally compounded drugs are drugs which often are created as less expensive alternatives to FDA approved ones. They do not have FDA approval, have no regulations and safety testing, and often do not contain the appropriate concentrations of the active drug.

They may have LESS active ingredient than labeled, so your money is wasted by an ineffective product, and your horse’s health continues to struggle; they may have MORE than intended, and be harmful for your horse.

In 2009, a vitamin & mineral supplement caused the death of 21 polo ponies due to too much Selenium. “Although the deaths of the polo horses received widespread news media attention, the unnoticed deaths of other animals due to illegally compounded medicine ‘is the greater tragedy,’ Bertone said. ‘These cases remain silent.'”

The cost savings found in illegally compounded drugs can sometimes be attributed to lower expenses related to quality, testing, purity, stability, safety, and efficacy.

Illegally compounded drugs are not “generic” drugs, as ibuprofen is the generic for Advil. Generic drugs are approved by the FDA, go through production in an FDA evaluated facility, and contain the same active drug and dosage of brand name drugs.

There are plenty of reputable pharmacies that distribute compounded drugs under the supervision of pharmacists and veterinarians. Seek these out for help with the recommendation of your own veterinarian. Be aware of the risks, and ask questions!

Take Away

Illegally compounded drugs should not be selected as a cost saving measure while treating horses. Your primary concern as a horse owner is the health and well being of your horses. In order to protect that health and well being, we don’t recommend choosing an unregulated drug, which is potentially ineffective and unsafe, even if it is cost-effective, unless there are no medical alternatives.

By Dr Lisa Nesson