Wednesday, May 16, 2007

Cushing's horse places second in equitation class after treatment


Posted to EC List May 16, 2007

My daughter's horse, Secret, started with an early case of
founder/laminitis. He was walking very stiff legged on front legs. We
called the vet. After testing, it was confirmed that he has Cushing's
disease. He is approximately 19 years old.

That was five months ago, in January. He has been on Pergolide since
then. His diet has also been changed to a very low carb diet. His
turn out is limited to about 3 hours a day.

My daughter recently took him to an "A" show locally. Together, they
placed Second in a class of about 15, age group 14 & under, in a 2'6"
equitation class.

The vet told us that after he has been on the treatment, we would
notice that it will be as if he were 5 years younger.

So far, this is true.

FDA Statement - Nuances

Posted on EC List May 15, 2007 Msg #91664

In case anyone is wondering about nuances in the FDA statement, what we
had requested was an exemption from the prohibition on compounding from
bulk drug. What we got was "regulatory discretion". The exemption would
have been a statement that they are allowing it, not considering it
illegal. The regulatory discretion basically means they'll look the
other way but technically they still consider it illegal. Either one
works for us; either one keeps the flow of drug to the compounders.
Only difference is the FDA saves face a bit more with regulatory
discretion. It's purely a matter of semantics. By either publishing an
exemption or making a public statement to the effect they will exercise
regulatory discretion in the framework of a valid prescription, they
are saying they won't move against the compounders or wholesalers. One
statement isn't any stronger than the other. Neither one actually
involves a change in law, and either one can be reversed just as
quickly as it was issued. However, until (and unless) an FDA approved
option comes along (see below), compounding will continue to be your
source of pergolide.

Also, "sponsors of approved product" refers to the 3 companies that
were making the pills before the recall; the only 3 companies that had
applied for and gotten FDA approval to market the drug. A "sponsor" is
a company that seeks FDA approval for a drug. An "approved product" is
a drug that has cleared the FDA approval process for a specific use(s).
So, the rest of the statement, beyond talking about compounding, was to
the effect that they are still trying to encourage the original pill
manufacturers to resume production, and are welcoming any new
sponsors/companies interested in picking it up specifically for equine

Eleanor - Pergolide: FDA to Allow Compounding From Bulk

The Food and Drug Administration's (FDA) Center for Veterinary Medicine announced on May 11 it will allow bulk pergolide to be used in compounding pergolide for use in horses.

"A lot of hard work by a large number of people went into getting this resolution," Kellon [Eleanor Kellon, V.M.D.] said. "We've been working on it since the week after the announcement of the drug's withdrawal. It's been a long six weeks, but we're all pleased that the FDA acted in time to prevent any horses having to go without treatment."


EquiSearch: FDA Clears Way for Compounding of Pergolide for Horses

A May 11 FDA announcement has cleared the way for compounding of pergolide for horses, but what does the fine print mean? Find out in this special bulletin from EQUUS magazine.

"What it boils down to is that they are allowing it for now," says Kellon [Eleanor Kellon, V.M.D.] "but if an actual drug company decides to start up manufacturing the pill form again or if a drug company wants to go down an official pathway to get it approved for equine use, the bulk compounding will again be considered illegal as soon as that source is up and running."