Post by schwung on May 2, 2007 13:57:29 GMT -5
Subject: Help Needed ASAP to keep Peroglide available for Cushings horses - Fwd: [EquineCushings] Re: PERGOLIDE - FDA]
From: corista@atlantic.net
Date: Wed, May 02, 2007 9:22 am
To: Horse_Rescue_and_Sanctuary@yahoogroups.com
Cc: BHFER List <BHF_Equine_Rescue@yahoogroups.com>
Below is a call for help from Dr. Eleanor Kellon, DVM (equine vet nutritionist/scientific researcher, published author, veterinary editor of The Horse Journal and John Lyons Perfect Horse) for much-needed help to convince the FDA to please make Peroglide available for horse owners to help with Cushings-afflicted horses.
Full info is in the email below, which contains Dr. Kellon's very informative statement, as well as a clickable link to the petition to the FDA, and contact info for the FDA officials who can make the decision to allow Peroglide to continue to be available for horse owners.
Please act to help all horses in need of Peroglide by signing the petition, forwarding and cross-posting this email, and contacting the FDA officials in a respectful, polite way to strongly encourage them to allow Peroglide to be continued to be available to horse owners.
Thanks!
Susan
Micanopy, FL
Begin forwarded message:
From: J Amick
Date: May 2, 2007 8:57:08 AM EDT
To: PasoAficion2@yahoogroups.com
Subject: [PAL] OT_[EquineCushings] Re: PERGOLIDE - FDA]
Would like to make all aware that the meds used for Cushings disease, peroglide, has been taken off the market by the FDA.
Removal was because of compounding pharmacies.
Below is a current update by Dr. Eleanor Kellon, DVM - co-owner of the Equine Cushings list - and has asked for help to cross post.
There are 5,000 listers on that Cushings list and it is not a chat group. Many a horse has been saved by the efforts of the people on that list, as it is cutting-edge info to help an owner with an insulin resistant or cushings horse.
Many PP's that are easy keeper are IR/ cushings...... My PP gelding is insulin resistant and is going into cushings disease.
Thanks,
Judy-PA
----------------
FDA folks to contact.... below....
David J. Horowitz
Deputy for Compliance Policy
Phone: 301-827-4225
Fax: 301-443-6591
david.horowitz@fda.hhs.gov <mailto:david.horowitz%40fda.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 <mailto:stephen.sundlof%40fda.hhs.gov>
Dr. Marcia Larkins
Ombudsman, Center for Veterinary Medicine
240-276-9015 phone
240-276-9060 fax
marcia.larkins@fda.hhs.gov <mailto:marcia.larkins%40fda.hhs.gov>
Virginia Behr
FDA - Ombudsman
Phone 301-796-0675
Fax 301-796-9883
virginia.behr@fda.hhs.gov <mailto:virginia.behr%40fda.hhs.gov>
Andrew von Eschenbach
FDA Commissioner
phone 301-827-2410
Fax 301-443-3100
andrew.voneschenbach@fda.hhs.gov
<mailto:andrew.voneschenbach%40fda.hhs.gov>
Eleanor's email for your information...
-----------------------
-
Re: Availability of pergolide mesylate for horses.
Pergolide has been in extra label use for the treatment of equine pituitary pars intermedia dysfunction for over 10 years. Several recent studies have documented clear superiority of pergolide over other treatments. A historical review is below.
With the voluntary withdrawal of finished pergolide from the human market, there is an urgent need for compounding pharmacies to have access to pergolide mesylate to fill valid prescriptions written in the framework of veterinarian-client-patient relationships conforming to the spirit and the letter of the 1994 AMDUCA.
After conversations with some principals in the FDA-approved compounding wholesale supply houses, I have learned they are reluctant to continue stocking pergolide for veterinary use and frequently refer to CPG 7125.40 as well as similar human compliance guidelines as the source of their reluctance. They believe that prior precedents have made, or will make, the importation of pergolide mesylate prohibited, and are concerned over the legality of providing bulk drug for this use.
I am the co-owner of an Equine Cushing's Disease support group on Yahoo that has over 5000 members:
pets.groups.yahoo.com/group/EquineCushings/
<http://pets.groups.yahoo.com/group/EquineCushings/>
A petition that was put up on line just before the Easter holiday, to document the need for pergolide for these horses, has already generated almost 3500 signatures, from owners and veterinarians, representing several thousand horses.
www.ipetitions.com/petition/savepergolide/index.html
<http://www.ipetitions.com/petition/savepergolide/index.html>
This is but the tip of the proverbial iceberg. There are an estimated 10+ million horses in this country, approximately 10% of which are age 20 or above. If only 1% of those are on treatment for Cushing's disease, an ultraconservative estimate, that's still 10,000 horses in need of access to pergolide mesylate, amounting to 3,650,000 1 mg doses (the average requirement) per year..
While other dopamine agonists are available for human use, there is no experience with these drugs in horses. There may be a reasonable expectation of efficacy, but no dosing and safety information is available. Loss of access to pergolide poses a very real and present danger to the health, even survival, of these horses.
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
Co-Owner
Equine Cushings and Insulin Resistance
pets.groups.yahoo.com/group/EquineCushings/
<http://pets.groups.yahoo.com/group/EquineCushings/>
Veterinary Editor
Horse Journal
www.horse-journal.com
John Lyons Perfect Horse
www.perfecthorse.com
From: corista@atlantic.net
Date: Wed, May 02, 2007 9:22 am
To: Horse_Rescue_and_Sanctuary@yahoogroups.com
Cc: BHFER List <BHF_Equine_Rescue@yahoogroups.com>
Below is a call for help from Dr. Eleanor Kellon, DVM (equine vet nutritionist/scientific researcher, published author, veterinary editor of The Horse Journal and John Lyons Perfect Horse) for much-needed help to convince the FDA to please make Peroglide available for horse owners to help with Cushings-afflicted horses.
Full info is in the email below, which contains Dr. Kellon's very informative statement, as well as a clickable link to the petition to the FDA, and contact info for the FDA officials who can make the decision to allow Peroglide to continue to be available for horse owners.
Please act to help all horses in need of Peroglide by signing the petition, forwarding and cross-posting this email, and contacting the FDA officials in a respectful, polite way to strongly encourage them to allow Peroglide to be continued to be available to horse owners.
Thanks!
Susan
Micanopy, FL
Begin forwarded message:
From: J Amick
Date: May 2, 2007 8:57:08 AM EDT
To: PasoAficion2@yahoogroups.com
Subject: [PAL] OT_[EquineCushings] Re: PERGOLIDE - FDA]
Would like to make all aware that the meds used for Cushings disease, peroglide, has been taken off the market by the FDA.
Removal was because of compounding pharmacies.
Below is a current update by Dr. Eleanor Kellon, DVM - co-owner of the Equine Cushings list - and has asked for help to cross post.
There are 5,000 listers on that Cushings list and it is not a chat group. Many a horse has been saved by the efforts of the people on that list, as it is cutting-edge info to help an owner with an insulin resistant or cushings horse.
Many PP's that are easy keeper are IR/ cushings...... My PP gelding is insulin resistant and is going into cushings disease.
Thanks,
Judy-PA
----------------
FDA folks to contact.... below....
David J. Horowitz
Deputy for Compliance Policy
Phone: 301-827-4225
Fax: 301-443-6591
david.horowitz@fda.hhs.gov <mailto:david.horowitz%40fda.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 <mailto:stephen.sundlof%40fda.hhs.gov>
Dr. Marcia Larkins
Ombudsman, Center for Veterinary Medicine
240-276-9015 phone
240-276-9060 fax
marcia.larkins@fda.hhs.gov <mailto:marcia.larkins%40fda.hhs.gov>
Virginia Behr
FDA - Ombudsman
Phone 301-796-0675
Fax 301-796-9883
virginia.behr@fda.hhs.gov <mailto:virginia.behr%40fda.hhs.gov>
Andrew von Eschenbach
FDA Commissioner
phone 301-827-2410
Fax 301-443-3100
andrew.voneschenbach@fda.hhs.gov
<mailto:andrew.voneschenbach%40fda.hhs.gov>
Eleanor's email for your information...
-----------------------
-
Re: Availability of pergolide mesylate for horses.
Pergolide has been in extra label use for the treatment of equine pituitary pars intermedia dysfunction for over 10 years. Several recent studies have documented clear superiority of pergolide over other treatments. A historical review is below.
With the voluntary withdrawal of finished pergolide from the human market, there is an urgent need for compounding pharmacies to have access to pergolide mesylate to fill valid prescriptions written in the framework of veterinarian-client-patient relationships conforming to the spirit and the letter of the 1994 AMDUCA.
After conversations with some principals in the FDA-approved compounding wholesale supply houses, I have learned they are reluctant to continue stocking pergolide for veterinary use and frequently refer to CPG 7125.40 as well as similar human compliance guidelines as the source of their reluctance. They believe that prior precedents have made, or will make, the importation of pergolide mesylate prohibited, and are concerned over the legality of providing bulk drug for this use.
I am the co-owner of an Equine Cushing's Disease support group on Yahoo that has over 5000 members:
pets.groups.yahoo.com/group/EquineCushings/
<http://pets.groups.yahoo.com/group/EquineCushings/>
A petition that was put up on line just before the Easter holiday, to document the need for pergolide for these horses, has already generated almost 3500 signatures, from owners and veterinarians, representing several thousand horses.
www.ipetitions.com/petition/savepergolide/index.html
<http://www.ipetitions.com/petition/savepergolide/index.html>
This is but the tip of the proverbial iceberg. There are an estimated 10+ million horses in this country, approximately 10% of which are age 20 or above. If only 1% of those are on treatment for Cushing's disease, an ultraconservative estimate, that's still 10,000 horses in need of access to pergolide mesylate, amounting to 3,650,000 1 mg doses (the average requirement) per year..
While other dopamine agonists are available for human use, there is no experience with these drugs in horses. There may be a reasonable expectation of efficacy, but no dosing and safety information is available. Loss of access to pergolide poses a very real and present danger to the health, even survival, of these horses.
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
Co-Owner
Equine Cushings and Insulin Resistance
pets.groups.yahoo.com/group/EquineCushings/
<http://pets.groups.yahoo.com/group/EquineCushings/>
Veterinary Editor
Horse Journal
www.horse-journal.com
John Lyons Perfect Horse
www.perfecthorse.com
