Sunday, April 29, 2007

Update April 9, 2007 (Includes letter to Wholesalers)

Posted to EC List 4/9/2007 Msg #89950

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!
-------------------------------

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/

1 comment:

mark said...

Thanks for sharing this information. Actually I was about to get rid go them. But now changed my mind. Once again thank you
-mark