FDA No Longer Supports Compounded Pergolide Production
- Topics: Article, Cushing's Disease, Medications
The U.S. Food and Drug Administration (FDA) will no longer support the production of compounded pergolide for use in horses, according to a recent statement from the agency. The change comes several months after the FDA approved a pergolide mesylate tablet (marketed as Prascend) for the treatment of clinical signs associated with pituitary pars intermedia dysfunction (PPID, or equine Cushing’s disease).
Previously, pergolide–considered the "gold standard" for treating signs of PPID in horses–was available for use in horses via an FDA-approved formula for human Parkinson’s disease. In 2007 the FDA announced that the drug was being voluntarily withdrawn from the market due to concerns about serious risk of damage to human patients’ heart valves. Shortly after, the agency announced that it would permit pergolide compounding for equine use since no FDA-approved treatment options were available.
A statement issued by the FDA at that time explained that the agency would work with interested parties (i.e., veterinarians and horse owners) to ensure that a compounded pergolide product was available to treat PPID signs in horses until a new animal drug application reached approval for that use.
In 2011 the FDA approved the first pergolide mesylate product specifically designed for use in horses to treat the signs of PPID
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