Plan "B" if US Supply Dries Up (plan ahead)

Posted on EC List 4/28/2007 Msg #90807

Re: Plan B - Pergolide

To stay on pergolide, your vet can apply for a Medically Necessary
Veterinary Drug exception. The details on how to do this are here:

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

In fact, that pathway was the initial suggestion we got from the FDA
before they realized the magnitude of the problem and decided they
didn't want to process thousands of these applications but if that's
what it takes to make them move, so be it. Please note that your vet,
or presumably your vet's office at least, has to call to request the
necessary forms. They won't send them out to owners. That document is
worth reading. It states that the FDA recognizes they have a
responsibility to get drugs out to the people or animals that need
them.

This process would allow your vet to import pergolide (e.g. from
Canada) for your horse. Price will be higher than compounded, but
nothing like what one member told she just paid yesterday for generic
pergolide pills that she located at a US pharmacy - ***OVER $6.00 PER
MG*** - more than double what she was paying. At 1 mg/day, at current
pricing, a 30 day supply would run about $60

http://www.seniormedications.com/drug_list/pergolide.htm

Another alternative, although highly experimental at this point,
would be to try cabergoline (brand name Dostinex) instead. You can
legally order this from a Candian pharmacy, generic version, at a
very low cost, possibly as low as $20/month. I apologize for not
sending out those cabergline files to those that requested them yet.
It was sounding so hopeful for an early solution a while back that I
held off, then got caught up in the pergolide problem again. Will do
that as soon as I finish this post. [If you require information on cabergoline
for your equine patients, please enter a comment at the end of this article
and you will be contacted.]

There are other dopamine agonists also, but we have ZERO information
on what dosages might be appropriate, safety, etc.

Vitex agnus-castus/Chastetree berry: Good track record for
symptomatic control (laminitis, coat quality, etc.) but not all
respond, those that do respond may become refractory to it. Also
concerning that the blood work doesn't necessarily reflect the
clinical improvements.

Now, back to plan A! Don't get too discouraged yet. The FDA is
sensitive to its public image. If it wasn't for the controversy over
compounding, they wouldn't be dragging their feet like they are. It's
not over yet.

Eleanor