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Pergolide

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We will try to provide updates on the pergolide situation.



As of 04/29/07:

Since the FDA apparently isn't doing it's homework on how much pergolide is out there in any form, I'd like as many people as possible to call 5, 10 or more pharmacies in your local area, ask them if they have any pergolide pills and if they do, how many, what strength. Jot down the date, pharmacy name and how much, if any, they have. Send that information to the "big 5" below, with a cc to me. If you are uncomfortable doing that, please send it to me (drkellon@aol.com) and I'll forward it identified only by your city/town.

The only legal source in the FDA's eyes is the pills. The sooner we can document they are gone, or about to be, the better.

David J. Horowitz
Deputy for Compliance Policy
Phone: 301-827-4225
Fax: 301-443-6591
david.horowitz@fda.hhs.gov

Stephen F Sundlof, D.V.M., Ph.D.
Director of the Center for Veterinary Medicine
Food and Drug Administration
240-276-9000 phone
240-276-9001 fax
stephen.sundlof@fda.hhs.gov

Dr. Marcia Larkins
Ombudsman, Center for Veterinary Medicine
240-276-9015 phone
240-276-9060 fax
marcia.larkins@fda.hhs.gov

Virginia Behr
FDA - Ombudsman
Phone 301-796-0675
Fax 301-796-9883
virginia.behr@fda.hhs.gov

Andrew von Eschenbach
FDA Commissioner
phone 301-827-2410
Fax 301-443-3100
andrew.voneschenbach@fda.hhs.gov

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As of 04/27/07:

Such as it is, here goes.

The Veterinary side of the FDA (CVM - Center for Veterinary Medicine), did prepare a proposal for an interim solution. I spoke to the officer (that's what they call them at the FDA, "officer") in charge of that. He would not tell me what was in it but did tell me that he had sent it over to FDA "main" for approval. The approval was expected to have occurred by last Friday at the latest (that was the announcement we were expecting) but never appeared. On Tuesday, he said he was hoping to see it "soon".

Part of the problem is priority. They're a tad distracted by the contaminated pet food fiasco (don't go there on this list please, much as I'd love to..) but even more important is that none of the immediate available options are very appealing to the FDA. Below is a list of the possible solutions that I just put together for a Horse Journal article:

1. The FDA could publish a specific exemption from the prohibition on compounding from bulk drugs with regard to pergolide and horses with Cushing's Disease. This would immediately free drug wholesalers to supply compounders. Drug should still only be produced upon receipt of a prescription from the treating veterinarian. This would be entirely legal and there are precedents for issuing exceptions. Certain chemicals used in treatments of poisonings have already been granted exceptions. We favor this as a short term solution.

2. The former USA manufacturers of pergolide pills in this country could be encouraged to resume production specifically for veterinary use.

3. The FDA could allow importation of pergolide pills produced in other countries.

4. A drug company could begin the drug approval process for pergolide as a treatment for equine PPID. This is time consuming and expensive, but preliminary communications with the FDA CVM staff in the division of MUMS - Minor Uses and Minor Species - indicates they may be able to help. This division was created to help fill the special needs of relatively uncommon species, or uncommon diseases. While the number of horses with Cushing's Disease is certainly not small, the market size can't compare to the need for things like dewormers and antibiotics. The program provides financial incentives and allows for sales of the drug before the entire approval process has been completed.

5. In the event the FDA does not offer even a short term solution quick enough, and an owner/vet find themselves unable to source the drug, the veterinarian can apply for a Medically Necessary Veterinary Drug exception. Details for this application can be found at: http://www.fda.gov/cvm/Policy_Procedures/4170.pdf/ Once approved, this would enable the veterinarian to import drug to treat his or her patient(s). Because of inherent delays in petitions being approved, and a likely large volume of petitions once the supply begins to dry up, you shouldn't wait until the last minute to get started on this.

===================

In speaking with the FDA on Tuesday, it was abundantly clear that granting an exception for bulk compounding was the last thing they wanted to do. The current compounding furor, with abuses on both human and veterinary ends, haven't helped us any. Still, this would be the quickest solution. The FDA would prefer to see 2. happen, but no interest from that sector so far. Number 3. is probably the solution that CVM proposed (I'm guessing at that), but FDA main wouldn't be wild about that idea either.

Number 4. is something I'm actively working on, identifying companies that are already making "specialty" drugs (smaller market than big sellers like dewormers or antibiotics), small companies, companies with experience producing drugs that are potent in small doses in a loose powder form.

Number 5. is your safety net. There's no way to tell how much pergolide is still out there, or how long it will last. Pharmacies that seem to have a good supply now could find it disappearing quickly as other pharmacies run out. If this drags on too long, you could also easily be looking at a problem with black market drug of god knows what quality and coming from god knows where. If the availability of drug through approved suppliers doesn't change, sooner or later you're going to have be highly suspicious of anyone who claims they have no problem getting the drug. The FDA is not interested in having to process a huge volume of these applications, but may try to stall on doing anything until they actually start to get them.

==========================

Until they have a solution in front of them that they like, the FDA is going to drag its feet. We need to keep putting pressure on them. All of you who cross-post and generate new signatures on the petition are helping. Several members are also getting breed associations involved and/or getting articles in magazines. I've been interviewed by The Horse, Equus and got a request late yesterday from Horse Illustrated. There will be an article in the next issue of Horse Journal. Also trying to get a national news service to pick it up.

You can all also help by sending individual e-mails, faxes or phone calls to these 3 people:

Food and Drug Administration
1-888-463-6332 - phone
cderombudsman@fda.hhs.gov

Dr. Stephen Sundlof
Director of the Center for Veterinary Medicine
240-276-9000 - phone
240-276-9001 - fax
stephen.sundlof@fda.hhs.gov

Dr. Marcia Larkins
Ombudsman, Center for Veterinary Medicine
240-276-9015 - phone
240-276-9060 - fx
marcia.larkins@fda.hhs.gov

Phone, fax, e-mail or all three as often as you like.

By the way, in response to the reply from the FDA that some of you got, basically saying it's not their problem and it's up to the manufacturers to supply the drug, that's not true. No manufacturer is obligated to make any drug. Few firms would be interested in this "small" a market, compared to something that the entire equine population uses on a regular basis.

The FDA does acknowledge that it has the responsibility to prevent or alleviate both real and potential shortages of essential drugs. Read:

http://www.fda.gov/cvm/Policy_Procedures/4170.pdf

This *is* their problem, but it's up to us to see that they deal with it before even one horse runs out of pergolide.

Eleanor

_____________________

As of 04/05/07:

Pergolide, the most effective treatment for horses with Cushings and the only thing that helps many of them has been taken off the market. For details drop in on the Cushings group:

http://groups.yahoo.com/group/EquineCushings

If you have or had a horse with Cushings, or know someone who does, please go to this site and sign the petition for drug manufacturers to keep producing the drug for equine use:

http://www.ipetitions.com/petition/savepergolide/index.html

Please also cross post this to all equine groups you are on.

Thank you.

Dr. Eleanor Kellon

____________________

According to the CBC at http://www.cbc.ca/health/story/2007/03/30/permax.html pergolide has voluntarily withdrawn the medication in both Canada and the United States. In Canada, however the drug is still protected under patent, and is sold by Shire Pharmaceuticals.

"It's going to be a matter of economics for the manufacturers. If the market is big enough to warrant it, they may keep producing for equine use."

"Cabergoline is a dopamine agonist in the same class as pergolide. It is more potent and longer acting. We do have at least preliminary information on its use in a small number of horses."

____________________

As many of you may know, pergolide (Permax) is being withdrawn from the market due to some heart valve problems with a subset of the people who take the medication. Pergolide is also pretty much the only available drug to treat Cushings Disease in horses. Since most of this drug is ordered through compounding pharmacies, it turns out the drug manufactures actually did not know about the equine market for the drug. In an effort to keep this life saving drug available for our Cushings horses, a petition has been started to demonstrate to the manufacturer the demand for pergolide. If you have or had a horse with Cushing's, or know someone who does, please go to this site and sign the petition for drug manufacturers to keep producing the drug for equine use:

http://www.ipetitions.com/petition/savepergolide/

Please take the time to sign and cross-post this information on any other lists or bulletin boards that you frequent. Also, if your horse is on pergolide, I think it would be helpful to note that in the comments section.

Feel free to ignore the request for donations at the ipetition web site after you sign the petition:-)

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From Dr. Eleanor Kellon:

I'm already starting to get mails from people using the human generics and Permax saying that their pharmacies are out. All three pill producers have stopped manufacturing. It appears that the only way the pills will be produced again is if one of the 3 manufacturers appeals to the USDA for a special permit. If that happens, that single manufacturer will be the only source of pill form pergolide. Anyone currently using pills would be wise to switch to compounded.

*The most accurate way to dose compounded pergolide is in capsule form. In addition, anyone making a switch to a compounder should make sure that:

1. The compounder is fully licensed.

2. The compounder only uses bulk drugs that come from FDA approved drug wholesalers. Ask for the name of their pergolide bulk drug wholesaler. If it's not on the list below, don't use that compounder.

The petition is going strong, creeping up on 700 signatures representing thousands of horses. In addition to signing the petition, I would encourage anyone who feels so inclined to contact the wholesalers directly by phone, fax or e-mail. When you do, be sure to mention the name of your compounding pharmacy. One or more of the wholesalers will recognize them as their clients and will be able to check their sales records. As soon as a wholesaler confirms they will continue to stock pergolide and keep the supply uninterrupted, we'll take them off our contacts list. Also provide a link to the petition when you contact them. This will be the quickest way to let them know we have a need - a BIG need! Remember, the drug is out there. The human market in the USA was very small compared to the rest of the world.

This is what I sent the wholesalers over the weekend and this morning. Directly below that is a list of the FDA approved wholesalers who were stocking pergolide and all the contact info I currently have.

Make your voice heard!

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I am a veterinarian and co-owner of the over 5000 member Yahoo Equine Cushing's group. As you know, at the FDA's urging pergolide mesylate has been removed from the human market. The three US suppliers of pergolide tablets are no longer producing the drug. What you may not realize is that bulk sales of pergolide to compounders are largely going to the veterinary market.

Pergolide is the only effective pharmacological therapy for horses with Cushing's Disease, pituitary pars intermedia dysfunction. I believe that drug wholesalers are unaware of the size of the veterinary market. It is critically important to keep pergolide available for veterinary use. The FDA action does not impact off-label use in horses.

A web petition has been put up to collect signatures and comments regarding the use of pergolide in horses:

http://www.ipetitions.com/petition/savepergolide/index.html

The petition was put up noon on April 6. Despite the holiday weekend, there are already 14 pages of signatures, reflecting the needs of thousands of horses. This is only the tip of the iceberg. There are currently 10 to 12 million horses in the United States, of which approximately 10% are age 20 or older. It has been estimated that virtually any equine that lives long enough will develop the degenerative changes of dopaminergic neurons that leads to pituitary dysfunction and Cushing's disease. This disease may begin much earlier in some horses, in their teens. Pergolide is needed by these animals for the remainder of their life.

We urge you to continue to stock pergolide mesylate. There is a market. Owners that had been relying on Permax or generic human tablets are already encountering shortages. There is an urgent need to keep an uninterrupted flow of pergolide mesylate to compounders.

Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
Co-Owner, Yahoo Equine Cushings
http://pets.groups.yahoo.com/group/EquineCushings/

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List of Wholesalers and Contact Information

Gallipot
Barbara Jones CEO bjones@gallipot.com
Michael Jones President mjones@gallipot.com
2400 Pilot Knob Road
St. Paul, Minnesota 55120
800-423-6967
Fax 800-339-1596

Medisca USA
sales@medisca.com
661 Route #3, Unit C
Plattsburgh NY 12901
800-932-1039

Medisca Canada
sales@medisca.com
6090 Henri-Bourassa West
West Saint-Laurent, Quebec
H4R 3A6
800-665-6334

Spectrum Chemicals
4422 S San Pedro St
Gardena CA 90248-2027
bulk@spectrumchemical.com
sales@spectrumchemical.com
Annette Farioli
800-813-1514
Fax: 800-525-2299

Hawkins
800-375-0009

Letco Companies
sales@letcoinc.com
1316 Commerce Drive
Decatur AL 35601
800-239-5288

Professional Compounding Centers of America (PCCA)
9901 South Wilcrest Drive
Houston, TX 77099
customerservice@pccarx.com
800-331-2498
Fax 800-874-5760

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Links to stories:

http://www.thehorse.com/viewarticle.aspx?ID=9317

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01596.html

To contact us, please go to the Contact Page.

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