Should You Give Up Compounded Pergolide'

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The FDA?s announcement that they will start cracking down on compounded formulations of pergolide has upset some horse owners, who seem determined to fight for their right to purchase the compounded drug, which costs about half what the FDA-approved formulation costs. ?I feel their pain, and I know this worked in the past, but the situation?s just not the same this time around.

Last time, when the FDA stopped the sale of pergolide for people in 2007 (it was used to treat Parkinson?s disease), owners of horses with Cushing?s syndrome panicked. The drug is the veterinarian?s gold-standard for treatment of Cushing?s ?(also called pituitary pars intermedia dysfunction or PPID), and horses weren?t exhibiting the problems the FDA found in humans (a high rate of damage to the heart valves). Plus, once a horse is on pergolide for Cushing?s he needs to remain on it for the rest of his life.

In case you're unaware, Cushing?s syndrome is develops predominately in some horses during their ?teen? years. It results from a pituitary tumor, which causes the endocrine system to go nuts (the endocrine system is composed of the glands in the body that secrete hormones).? Symptoms of this syndrome include long coats that either are very slow to shed or won?t shed at all, increased thirst and urination, increased appetite with weight loss, muscle wasting, chronic laminitis, pot belly/swaybacked appearance. Many of these horses are also insulin-resistant. A veterinarian can usually confirm the diagnosis with simple blood tests. Cushing?s is not a horse-only disease, as other animals and people can battle it, too.

Fortunately, due to those very determined Cushing?s horse owners in 2007, the FDA relented on pergolide for horses, allowing owners to purchase the drug formulation from compounding pharmacies, with a prescription from their veterinarian, of course. ?Veterinarians are allowed to write prescriptions for compounded drugs and/or use drugs for off-label uses when there is no other commercial product available that will do the same thing.

Compounded pergolide, it seems, was a windfall for veterinary compounding pharmacies, who began advertising the drug?s availability and producing it at competitive prices. Unfortunately, incidents of unstable pergolide began to appear. ?A study determined that the compounded drug had to be used within 30 days of manufacturing and stored in a dark container in a refrigerator (http://www.ncbi.nlm.nih.gov/pubmed/19210262), but that only solved part of the problem. Not all compounding pharmacies are of the same caliber, nor do they all use the same quality of ingredients, and it's extremely difficult to determine which is which (a problem the FDA should consider tackling).

So, late last year, along comes Prascend, the new FDA-approved commercial pergolide for horses, which technically should have immediately ended the compounding days of the drug. ?It didn't though, as horse owners didn't want to switch from a $25-$30/month drug cost to $60 or more. And who could blame them' The prices depend upon the amount of pergolide the horse needs (depends upon the horse's blood test results) and the supplier, of course.

it's important, thought, to remember that this isn?t your veterinarian?s fault. With the FDA?s warning a few days ago, I sure wouldn?t risk trouble if I were a veterinarian. That said, you should be able to ask your veterinarian for a prescription for Prascend and then shop around yourself for the best price.

Remember, a few things, though. First, your veterinarian probably can't compete price-wise with a large online pharmacy selling Prascend, due to wholesale costs based upon volume purchased. ?Second, if your veterinarian balks at writing a prescription he or she knows you plan to take to a compounding pharmacy but does anyway, you may find your relationship with that veterinarian is over when you call again. Third, if you purchase all your meds from another distributer, instead of your own veterinarian, you may find that your vet eventually can no longer afford to carry any medications. That may mean your ill horse may have to wait to get medication via an overnight delivery service (we're talking emergency meds in this instance).

So, yes, veterinarians make a profit on the sale, but it's not a big ?conflict of interest,? as some people like to say. The issue is availability. ?If your veterinarian no longer carries drugs because it's not economically feasible (after all, veterinarians are doing this to make a living), where are you going to get a drug when you need it immediately in an emergency' Your human pharmacy may not carry a veterinary drug, and overnight services are expensive. Meanwhile, your ill horse has to wait.

Sure, Prascend is different, as it's a drug for a chronic illness. So, it's understandable if you want to get your first dose from your vet and ask for a prescription for the long haul. I doubt any vet will object to that. But, as a consumer, you might want to consider avoiding compounding pharmacies and shop around for the brand name Prascend. Unless, of course, you know for certain that the compounding pharmacy is using high-quality ingredients in a stable formation and that it's not illegal.