Friday, May 11, 2007

Pergolide shortage over


For those of you with a horse suffering from "Cushings disease" and have been treating it with Pergolide, there is some good news. It appears that Pergolide may remain available for use in horses.Cushings disease is caused by an adenoma on the pituitary gland that causes the increased production of POMC or proopiomelanocortin and cortisol precursors. This leads to hirsutism(long hair coat) laminitis, hoof abscesses and chronic infections.
Pergolide has been the best treatment we have had for this condition and recently it has become unavailable for humans where it is used as a treatment for Parkinsons disease due to cardiac health concerns. Here is a link to a blog set up for the issue and a petition if you are interested. Fran Jurga has also posted about it.Here is a copy of a recent letter that should give us hope that the FDA will make it available for Veterinary use.

The AAEP has, for the past several years, been working closely with the Center for Veterinary Medicine at the Food and Drug Administration to understand the policies governing compounding as it relates to equine practice. As a result of the recent withdrawal of pergolide from the market due to human health concerns, the AAEP contacted the FDA in an effort to educate and emphasize the importance of this drug to equine practitioners and their clientele. The AAEP received the communication below from the FDA and with it we feel that there will not be a crisis due to a pergolide shortage. The FDA recognizes the importance of these drugs and because of a healthy alliance with the AAEP, the Agency learned of the situation quickly and made its decision to apply regulatory discretion to the compounding of pergolide from bulk sources. Compounding pharmacies should not experience any shortage of the bulk product.


5/9/07

From: The Office of the Director, Center for Veterinary Medicine, Food and Drug Administration

To: The American Association of Equine Practitioners


Dear Dr. Morehead and Mr. Foley:

Thank you for contacting us on behalf of the American Association of Equine Practitioners (AAEP) regarding pergolide. FDA’s Center for Veterinary Medicine (CVM) has also gotten a number of inquiries from horse owners who are very concerned about the issuance of an FDA Public Health Advisory (PHA) detailing the removal of pergolide products from the market. The PHA is available at www.fda.gov/cder/drug/advisory/pergolide.htm. Pergolide is being removed from the market due to concerns about cardiac side effects in humans. As you are aware, pergolide is currently not approved for use in animals.

CVM recognizes that veterinarians prescribe pergolide for the treatment of Cushings Syndrome 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 continues to work with the sponsor of the approved product and all other interested parties to ensure pergolide remains available to treat Cushings Syndrome in horses until a New Animal Drug Application (NADA) 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, including from a bulk substance labeled for “animal use only,” under a valid veterinary prescription to treat an affected horse.

CVM will also work with sponsors who are interested in seeking approval of a NADA for the use of pergolide to treat Cushings Syndrome in horses.

We appreciate the opportunity to work with you on this matter.

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