On March 16, the FDA basically sent out a warning about veterinarians or horse owners who have been using compounded pergolide to treat Cushing?s disease in horses. Since Prascend Tablets are now approved to treat this condition in horses, the allowance for compounded and ?extra label? versions is gone.
When there is no version of a medication specifically approved for a species, the FDA will allow compounding to be done under the ?extra label use? rulings. This was the case with the human version of pergolide used to treat horses. When that medication was withdrawn from the market due to human complications, the FDA allowed compounding pharmacies to make up an equine version. Now that there is an approved equine version of the medication, that will no longer be allowed. Prascend was approved in September 2011.? The FDA probably waited to allow already manufactured supplies to be used, but they now plan to enforce their rulings.