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.

Pergolide mesylate, a drug commonly used to treat pituitary pars intermedia dysfunction (PPID), also known as equine Cushing's disease, was withdrawn for human use March 29 because of a risk of damage to the heart valves of human patients.

Veterinarians could prescribe pergolide for PPID horses as an "extralabel" use of the approved human product. Once pergolide was withdrawn for its approved use in humans, there was no legal way for wholesalers to bring the drug into the country, because compounding from bulk drug is considered illegal by the FDA.

The statement allowing bulk pergolide use read, in part:

"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."

The Center for Veterinary Medicine will also work with manufacturers interested in producing the drug domestically for veterinary use.

The full statement can be accessed here.

Eleanor Kellon, VMD, co-owner of the Yahoo Equine Cushing's and Insulin Resistance Group, reported last week (May 4) that the supply of pergolide left over from human pharmacies had all but disappeared, and that a crisis was inevitable unless the FDA took immediate action.

"A lot of hard work by a large number of people went into getting this resolution," Kellon 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.

"After extensive polling of veterinarians last week, it was looking like the lower end estimate of horses on pergolide was in the neighborhood of 60,000 to 70,000. The FDA's action has averted a crisis in health care."

The American Association of Equine Practitioners (AAEP) also worked to encourage the FDA to provide the exemption for importing bulk pergolide. A statement sent to member veterinarians today read, in part:

"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 ... Compounding pharmacies should not experience any shortage of the bulk product."

About the Author

Erin Ryder

Erin Ryder is a former news editor of The Horse: Your Guide To Equine Health Care.

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