Pergolide Cleared for Equine Veterinary Use by FDA


This announcement just in from the FDA:

May 11, 2007

CVM Working to Address Concerns about Supplies of Pergolide for Horses

The Center for Veterinary Medicine (CVM) is aware that veterinarians and horse owners are concerned about the issuance of an FDA Public Health Advisory (PHA), www.fda.gov/cder/drug/advisory/pergolide.htm, detailing the removal of pergolide products from the market. Pergolide, a drug used to manage the signs and symptoms of Parkinson's disease in humans, is being removed from the market due to concerns about cardiac side effects.

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.

Although the sponsor has stopped marketing pergolide for human use, CVM will also work with sponsors who are interested in seeking approval of a new animal drug application for the use of pergolide to treat Cushing's Syndrome in horses.

For more information, contact Christopher Melluso, DVM, at Christopher.Melluso@fda.hhs.gov or (240) 276-9065.