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Dr. Coates is a veterinarian based in the other “Sunshine State” – that's Colorado to the rest of you – where she lives and plays with a varied range of animals. She shares her professional and personal experiences, Monday through Friday, here on petMD's blog, the Fully Vetted. Log in for your daily dose of her insight and wisdom.

Would You Choose an FDA Approved or Compounded Drug?

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January 16, 2012 / (7) comments

Veterinarians use a lot of human medications to treat animals. The cold, hard reality is that there is more money in developing meds for people, so vets are often left looking at what’s available in the human sphere and trying to figure out what may or may not be useful in animals.

 

In most cases, this situation works pretty well, but when a human drug is pulled from the market, the fact that veterinarians have come to rely on it is usually not enough to keep it in production. This was the case when in 2007 the medication pergolide, which had been used to treat Parkinson’s disease in people, was withdrawn from the U.S. market because it was linked to problems with patients’ heart valves. Unfortunately, pergolide was also the go to treatment for a condition in horses called Pituitary Pars Intermedia Dysfunction (PPID), or Cushing’s disease.

The symptoms of PPID in horses include a long, curly coat that doesn’t shed normally, increased thirst and urination, muscle wasting, abnormal fat distribution, excessive sweating, lethargy, laminitis, and recurrent infections. Most animals are middle aged or older when they are diagnosed. Pergolide certainly isn’t a miracle cure for PPID. Affected horses have to receive the medication for the rest of their lives, and the costs do add up, but it is the best tool we have for controlling their symptoms.

When human pergolide was discontinued, horse owners were forced to turn to compounding pharmacies.  Compounding pharmacies had been making pergolide from bulk materials even when the Food and Drug Administration (FDA) approved human product was available, but previously owners could choose which option was right for their situation.

Compounding pharmacies usually do a good job, but their products do not receive oversight from the FDA. Mistakes have been made in the formulation of compounded products (remember the 21 polo ponies that died in 2009), and they often do not have the shelf life and consistent drug delivery of FDA approved medications.

If you have a horse with PPID, I have some good news for you. Prascend, a new veterinary, FDA approved version of pergolide is now available.  I strongly recommend you talk to your veterinarian about whether or not Prascend is a good choice for your horse. It looks like Prascend is more expensive than compounded pergolide (at least for now; I’ve seen prices drop precipitously on newly released FDA approved veterinary products in the past), but the benefits of safety, consistency and stability are certainly worth something.

Pet owners and veterinarians also need to support drug manufacturers that are willing to get FDA approval for their products. If we don’t, there may not be many left to choose from.

 

 

Dr. Jennifer Coates

 

 

Image: Mehmet Dilsiz / via Shutterstock

 

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COMMENTS (7)
1
FDA approved meds
by Elizabeth and The Lab Crew on 01/16/2012 09:27am

Would I choose them, you betcha! I know literally hundreds of dog owners who use compounded Florinef, a MUCH cheaper alternative to brand name florinef for their dogs with Canine Addison's. Brand name florinef costs approx $1 a tablet or more in the US and less in Canada (approx 0.35 a piece here from a pharmacy). My dog was on florinef and I could not get compounded in Canada where I am and his florinef costs went from $33 a month to $175 a month as hid dose rose from .4mg a day to 2.2mg a day in just 7 months and that was 4 years ago when it was 0.27 cents a pill.
Compounded florinef on the other hand will cost approx $30 to $35 a month no matter what the dose of florinef because the cost is in the compounding. Yes you need to choose a compounding pharmacy that is used to working with animals but still for some people it makes the difference between keeping their dogs alive or euthanizeing them. Had I been in the US I could never have afforded $1 a tablet at 22 a day for my boy.

On the other hand talking about drugs taken off the human market Percorten V was one of those. It was being used off label to treat canine Addison's but humans preferred to use the oral med florinef so Ciba-Geigy discontinued it. There was a huge out cry from Vets and dog owners who knew their dogs would die without the drug. Here is the story of it, and how it came to be a Veterinary drug..
http://lab-mom.blogspot.com/2012/01/fascinating-story-of-percorten-v.html

So our voices can be heard, we just have to raise them sometimes...

2
Compounding Pharmacy
by TheOldBroad on 01/16/2012 09:51am

Not only do I trust my vet implicitly, I trust my compounding pharmacy completely.

If my vet were to suggest a compounded medication, I wouldn't hesitate.

I've had many medications compounded for the right dosage because it's difficult, if not impossible, to break a tablet into 0.3 mg of Norvasc.

3
Very interesting
by ASDMarlene on 01/16/2012 10:33am

this is very interesting and something that's probably not known to many animal owners unless it affects them directly. Maybe veterinarians could ask their clients if they would like to be alerted of any drug issues by them so they would have the opportunity to have a voice when something like this comes up. Most vets now do have e-mail access and as far as I am concerned I would appreciate such alerts in regards to important drugs for animals, and I would take the time to write letters to whoever needs to be approached.

by ASDMarlene on 01/17/2012 12:59am

forgot to respond to compounding meds issue. I have never had a medication compounded, doesn't mean I never would. I would decide on a case by case basis.

4
Thank-you Doctor Coates
by kay morris on 01/16/2012 01:47pm

When the Pharmacy, I use could not get my Armour thyroid, Thank God for for our local Compound Pharmacy, wirh out them I would have been in a bad-way, cost me a little more, I stand by The Compound Pharmacy. As for as my Pet-Kid's Doctor
what ever He orders, I will do, He is the best of the Best.

5
Compounding
by Flyinsbt on 01/16/2012 10:57pm

I do use a compounded medication for my dog. I have a dog with Cushings, and she is on trilostane. It is available as a name brand medication in a limited set of dosages, and at a prohibitively high price. I am able to get just the right dosage for her from a compounding pharmacy, at a relatively affordable $55/6 week supply.

Sadly, as much as I love my dog, and appreciate that a company developed and marketed this medication so I could have it available; I could not afford to purchase it if I had to pay the name brand price. I would have to make a horrible choice. So yes, sticking with the meds provided for me by a compounding pharmacy, and grateful to them for providing me that service.

6
by IACP on 01/20/2012 11:29am

Thanks to advances in veterinary medicine, animals are living longer, healthier lives. But these older animals also develop more health conditions and require more complex pharmaceutical therapy. It is unrealistic to think that these complex therapies could be prepared using only finished, commercial products. With the diversity of species kept as pets today, and the complexity of the drug therapies these pets need, it is crucial that compounding pharmacies have continued access to pure active pharmaceutical ingredients in order to provide veterinarians the customized medications they need to serve their patients.
To find a compounding pharmacist in your area – the International Academy of Compounding Pharmacists (IACP) provides a toll-free referral line at 800/927-4227, or go to IACP’s website at www.iacprx.org.

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About fully vetted

Jennifer Coates, DVM

Photo of Dr Coates

Image credit: Jim Piraino

...graduated with honors from the Virginia-Maryland Regional College of Veterinary Medicine in 1999. In the years since, she has practiced veterinary medicine in Virginia, Wyoming, and Colorado. She is the author of several books about veterinary medicine and animal care, including the Dictionary of Veterinary Terms: Vet-Speak Deciphered for the Non-Veterinarian. Dr. Coates also writes short stories that focus on the strength and importance of the human-animal bond, and freelance articles relating to a variety of animal care and veterinary topics. Dr. Coates lives in Fort Collins, Colorado with her husband, daughter, and various species of pets.

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