Pergolide Availability: No FDA Announcement, Supplies Running Low

More than a month after 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a drug commonly used to treat pituitary pars intermedia dysfunction (PPID), also known as equine Cushing's disease, was withdrawn for human use, the FDA has yet to make an announcement on whether it will allow bulk shipments of the drug to be imported for veterinary use.

To ensure an uninterrupted supply of pergolide, the FDA would need to publish a specific exception for the importation of pergolide for veterinary use, and also a specific exception to the prohibition of use of bulk drugs in veterinary compounding.

Pergolide, a dopamine agonist formerly used to treat Parkinson's disease, was withdrawn for human use March 29 because of a risk of damage to patients' heart valves. Eleanor Kellon, VMD, co-owner of the Yahoo Equine Cushing's and Insulin Resistance Group, said at least 10,000 horses will be directly affected if the drug is not made available.

Media contacts for the FDA Center for Veterinary Medicine did not immediately return a call for comment.

"The supply of the human drug has all but disappeared," Kellon said. "Some (pharmacies) never stocked it, others sold out, some returned what they had for a refund, and still others were told to return what they had.

"We desperately need the FDA to issue a specific exception to the prohibition on compounding from bulk drug as it pertains to pergolide for horses with Cushing's Disease/PPID," Kellon stated. "They could do this today, post it, and immediately open up the flow of drug through Customs to wholesalers and compounders."

If no exemption is posted, Kellon is recommending that veterinarians with equine patients on pergolide fill out a Medically Necessary Veterinary Drug import request. An example of this request, which includes the questions that requesting veterinarians need to address in order to gain approval, can be found on the Pergolide Action blog at http://pergolideaction.blogspot.com. Kellon noted that while this "safety net" might get horses through until an exemption is posted, it is not a long-term solution.

Kellon also suggested that horse owners sign the pergolide petition at www.ipetitions.com/petition/savepergolide. Updates on the number of signatures are being submitted to the FDA weekly. Horse owners and veterinarians are also encouraged to contact the individuals listed at the top of the petition.

"If this drags out much longer, it could still be too late to prevent horses from running out," Kellon said. "Symptoms of lethargy, increased thirst, increased urination, and laminitis can reappear within two to three weeks of being off the drug."

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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