Statement just issued by FDA, Center for Veterinary Medicine
http://www.fda.gov/cvm/pergolide.htm
"CVM recognizes that veterinarians are prescribing pergolide for the treatment of Cushing’s Syndrome in horses. Veterinarians have been prescribing the drug under the provisions of the Animal Medicinal Drug Use Clarification Act which allows veterinary practitioners to prescribe approved human drugs for “extralabel” use in animals.
"FDA is working with the sponsors of the approved products and all other interested parties to ensure that pergolide remains available to treat Cushing’s Syndrome in horses until a new animal drug application is approved for that use. This includes trying to make the approved product available through veterinary distribution channels and exercising enforcement discretion as appropriate over the pharmacy compounding of pergolide. Bulk substance used for pharmacy compounding should be labeled for “animal use only.” All pharmacy compounding must be done under a valid veterinary prescription to treat an affected horse."
Friday, May 11, 2007
Letter to Congressional Horse Caucus
This letter was sent to the Co-Chairs of the Congressional Horse Caucus on behalf of the over 5000 members of the Equine Cushings list and all owners of horses afflicted with Cushing's disease.
FDA Action Causes Horse Health Crisis
Dear Congressmen Stearns and Chandler,
As co-chairmen of the Congressional Horse Caucus, we are writing to ask for your urgent help in requesting the FDA to act upon the drug crisis now facing approximately 75,000 horses in the United States afflicted with Cushing’s Disease or Pituitary Pars Intermedia Dysfunction (PPID).
As you know, on March 29,2007, the FDA asked for voluntary withdrawal of the drug pergolide used in the treatment of Parkinson’s disease secondary to studies confirming cardiac valvular dysfunction in a small subset of human patients. The FDA was apparently not aware of the impact withdrawal of this drug posed to horses diagnosed with Cushing’s Disease. For the past 10 years, pergolide has been the Gold Standard treatment for this disease. While pergolide does not cure PPID, it allows for equines to maintain an excellent quality of life and function. At present, there are no viable drug therapy substitutes for pergolide.
Our group is led by the nationally known and published equine veterinarian; Eleanor Kellon, VMD.[i] Dr. Kellon is co-owner and veterinary advisor of the Equine Cushing’s List (http://groups.yahoo.com/group/EquineCushings). We are over 5,000 members strong (including international members) and we are fighting to ask the FDA to issue a specific exception to the prohibition on compounding from bulk drug as it pertains to pergolide in equines with PPID.
Dr. Kellon has conservatively estimated that of the 10 million horses in the United States, approximately 75,000 are afflicted with PPID.[ii] As of the week of May 2nd, our group has confirmed from ALL compounding wholesalers that NONE have ordered pergolide and NONE will do so until the FDA gives the green light. Additionally, we now estimate that there is only a six week supply of the drug in the United States as of May 9th.[iii]
Without this drug, these horses face certain euthanasia. The primary cause of death will be laminitis secondary to their uncontrolled disease; the very same laminitis that took the lives of Barbaro and Secretariat.
Congressmen, you are both from states with large equine populations. You understand that the equine industry is a vital part of our economy. Both of you and the members of your caucus have already demonstrated your commitment to the equine population by your exceptional work on the Horse Protection Act.
We have contacted the FDA to no avail. Since the March 29th FDA announcement, Dr. Kellon and many of our members have had direct contact (phone, fax, and e-mail) with the appropriate individuals at the FDA. There is still NO definitive plan in place to resolve this crisis. We strongly feel that it will take the voice of Congress to alert the FDA to the consequences of their inaction. By asking the FDA to issue a specific exception to the prohibition on compounding from bulk drug as it pertains to pergolide in equines with PPID you and the members of the Congressional Horse Caucus will save the lives of thousand of horses.
Thank you for considering these horses as constituents of your respective states. Thank you for helping us save the lives of these horses and for ensuring that their devoted owners will have the medication they need for their equine companions.
Sincerely,
Susanna R. Gordon, MD
List Moderator, Equine Cushing’s Group
Kathleen Gustafson, PhD
List Moderator, Equine Cushing’s Group
________________________________________
[i] For further information, Dr. Kellon may be contacted at:
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
drkellon@aol.com
[ii] Canvass of Equine Veterinarian Practices, May 2007
[iii] Communication between Eleanor Kellon, V.M.D. and suppliers, April and May, 2007
For background summary, please see articles at:
http://www.thehorse.com/ViewArticle.aspx?ID=9526&nID=7
http://www.thehorse.com/ViewArticle.aspx?ID=9405&kw=pergolide
Current petition signatures as of 10 May 2007:
http://www.ipetitions.com/petition/savepergolide/signatures.html
FDA Action Causes Horse Health Crisis
Dear Congressmen Stearns and Chandler,
As co-chairmen of the Congressional Horse Caucus, we are writing to ask for your urgent help in requesting the FDA to act upon the drug crisis now facing approximately 75,000 horses in the United States afflicted with Cushing’s Disease or Pituitary Pars Intermedia Dysfunction (PPID).
As you know, on March 29,2007, the FDA asked for voluntary withdrawal of the drug pergolide used in the treatment of Parkinson’s disease secondary to studies confirming cardiac valvular dysfunction in a small subset of human patients. The FDA was apparently not aware of the impact withdrawal of this drug posed to horses diagnosed with Cushing’s Disease. For the past 10 years, pergolide has been the Gold Standard treatment for this disease. While pergolide does not cure PPID, it allows for equines to maintain an excellent quality of life and function. At present, there are no viable drug therapy substitutes for pergolide.
Our group is led by the nationally known and published equine veterinarian; Eleanor Kellon, VMD.[i] Dr. Kellon is co-owner and veterinary advisor of the Equine Cushing’s List (http://groups.yahoo.com/group/EquineCushings). We are over 5,000 members strong (including international members) and we are fighting to ask the FDA to issue a specific exception to the prohibition on compounding from bulk drug as it pertains to pergolide in equines with PPID.
Dr. Kellon has conservatively estimated that of the 10 million horses in the United States, approximately 75,000 are afflicted with PPID.[ii] As of the week of May 2nd, our group has confirmed from ALL compounding wholesalers that NONE have ordered pergolide and NONE will do so until the FDA gives the green light. Additionally, we now estimate that there is only a six week supply of the drug in the United States as of May 9th.[iii]
Without this drug, these horses face certain euthanasia. The primary cause of death will be laminitis secondary to their uncontrolled disease; the very same laminitis that took the lives of Barbaro and Secretariat.
Congressmen, you are both from states with large equine populations. You understand that the equine industry is a vital part of our economy. Both of you and the members of your caucus have already demonstrated your commitment to the equine population by your exceptional work on the Horse Protection Act.
We have contacted the FDA to no avail. Since the March 29th FDA announcement, Dr. Kellon and many of our members have had direct contact (phone, fax, and e-mail) with the appropriate individuals at the FDA. There is still NO definitive plan in place to resolve this crisis. We strongly feel that it will take the voice of Congress to alert the FDA to the consequences of their inaction. By asking the FDA to issue a specific exception to the prohibition on compounding from bulk drug as it pertains to pergolide in equines with PPID you and the members of the Congressional Horse Caucus will save the lives of thousand of horses.
Thank you for considering these horses as constituents of your respective states. Thank you for helping us save the lives of these horses and for ensuring that their devoted owners will have the medication they need for their equine companions.
Sincerely,
Susanna R. Gordon, MD
List Moderator, Equine Cushing’s Group
Kathleen Gustafson, PhD
List Moderator, Equine Cushing’s Group
________________________________________
[i] For further information, Dr. Kellon may be contacted at:
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
drkellon@aol.com
[ii] Canvass of Equine Veterinarian Practices, May 2007
[iii] Communication between Eleanor Kellon, V.M.D. and suppliers, April and May, 2007
For background summary, please see articles at:
http://www.thehorse.com/ViewArticle.aspx?ID=9526&nID=7
http://www.thehorse.com/ViewArticle.aspx?ID=9405&kw=pergolide
Current petition signatures as of 10 May 2007:
http://www.ipetitions.com/petition/savepergolide/signatures.html
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