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Cushings Crisis
April 2007

Special thanks to Susie Gordon, MD, Equine Cushing's Moderator who sent this information and obtained the permissions to post this on Dressage.com

Urgent Information For Owners Of Cushing’s Horses

On 3/29/2007 , the Food and Drug Administration (FDA) announced that American drug companies had voluntarily withdrawn Pergolide (Permax) and Pergolide generics from the market. Recent studies in The New England Journal of Medicine confirmed earlier studies that associated Pergolide with cardiac mitral, tricuspid, and aortic regurgitation in humans taking the drug for Parkinson’s disease.

This voluntary recall has serious and potentially devastating implications for owners of horses diagnosed with Cushing’s disease as Pergolide and Pergolide generics have been the mainstay of treatment.

Eleanor Kellon, VMD co-owner and moderator of the Equine Cushing’s List http://groups.yahoo.com/group/EquineCushings is spearheading a nationwide effort to urge companies who market and distribute Pergolide to keep this drug available for veterinary use.

How can YOU help?

We need owners of Cushing’s horses, veterinarians, and pharmacists to PLEASE sign the following online petition at http://www.ipetitions.com/petition/savepergolide/

PLEASE let these drug manufacturers know how important this drug is to your horse, your clients, and to your pharmacy practice.

Ian Hudgings, Equine Cushing’s member and a pharmacist in Colorado has done considerable work in tracking down key information regarding Pergolide availability.

The following was written by Dr. Kellon at the Equine Cushing’s website and is the most current information we have regarding Pergolide availability:

“Thanks to Ian chasing down the details of the flow of pergolide, we now know that the pergolide being used in your compounded veterinary/equine drugs, as well as the pergolide that is in generic human capsules and even the brand name Permax, is all coming from chemical manufacturers that are for the most part located in southeast Asia.

Veterinary compounders get their pergolide from drug wholesalers. There are, according to Ian, 7 drug wholesalers in the US that were carrying bulk pergolide. They do *not* manufacture it. They buy it for the most part from these Asian chemical companies. I'm sure the same is true in Canada . Shire is manufacturing pergolide tablets, brand name Permax, but they're not actually manufacturing the drug itself. They're buying it from these Asian chemical companies in bulk then making it into a pill.

What this means, bottom line, is that there is no reason for our pergolide supply to dry up. The Asian chemical companies do business worldwide. Sale of pergolide for human use has only been banned in the US, but the FDA doesn't care if wholesalers buy it and sell it for veterinary off-label (not officially FDA approved) use because veterinarians have always had a lot of freedom to prescribe any drug they choose regardless of whether it is FDA approved for animal use (with notable exceptions for food animals).

The current problem is that 3 of the 7 US wholesale suppliers have stopped stocking pergolide. The remaining 4 haven't made up their mind. Forget about the 3 drug companies I was talking about before. They are human pill manufacturers and while we will include them in the blitz they're not the people we need to target. It's the bulk pergolide for compounding drug wholesalers we need to hit.

There's a very good chance these wholesalers don't even know there is a veterinary market, let alone the size of it. Odds are that almost all of the bulk pergolide sales they had were actually going to compounders making products for horses. What we need to do is make them aware of that.

Action Plan

I've been following the petition all afternoon. It's going strong, almost 120 signatures in 7 to 8 hours. Keep spreading the word. Put up messages on every horse group you're on and e-mail every horse owner you know.

I spent a few hours this afternoon contacting compounding pharmacies and associations. We need prescription numbers. All of you using pergolide please contact your compounder and ask them to sign the petition and also include the number of yearly or monthly veterinary prescriptions they fill. Those numbers are absolutely critical. Many of the compounding pharmacies also do human compounding so the wholesalers may not get a completely accurate impression of what the drug is being used for by checking their sales records.

Ask your vets to go sign the petition and take a minute to make a comment on how many horses in their practices are on pergolide.I've already notified my vets only group, and tomorrow will tackle the AAEP and American Horse Council for support.

There's no reason we have to lose access to pergolide. The key players right now are the wholesalers selling to compounding pharmacies and to a lesser extent the companies that are making pills. The drug is there, available without question. We just have to convince the wholesalers to keep stocking it. The sooner we can put the pressure on them the better. Ian said one wholesaler that's still carrying it has already raised their prices by 400%. It's not clear yet whether this is just one wholesaler price gouging (most likely), or if international prices are going up in response to the FDA action, but either way the more wholesalers we can keep in the game, the more competitive pricing will remain.

We have a lot of power. Let's put it to use. And, regardless of where you buy your horse's pergolide, let's give Ian a standing ovation. We had a few false starts trying to sort through this issue in the past week but he's been indispensable in getting to the root of the problem.”

Eleanor

Your Help Is Needed NOW!!

As Dr. Kellon says, we are a powerful force. Please sign the petition at http://www.ipetitions.com/petition/savepergolide/

Let your veterinarians, farriers, and pharmacists know that Pergolide is CRUCIAL to the health and well being of our Cushing’s horses.

Updated information on the Pergolide availability can be obtained by joining the Equine Cushing’s list at http://groups.yahoo.com/group/EquineCushings

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