FDA ends pergolide compounding exception

Rockville, Md.

— The U.S. Food and Drug Administration (FDA) released a statement to veterinarians in regard to compounding of pergolide products to treat Cushing's disease in horses.

Veterinarians had for many years prescribed pergolide products to treat Cushing’s disease in horses under the “extra-label” use provisions of the Federal Food, Drug and Cosmetic Act. But in May 2007, human pergolide products were removed from the market due to cardiac side effects in humans. As a result, FDA told veterinarians it would work with sponsors of the human-approved drug to ensure that pergolide remained available to treat Cushing’s disease in horses until a new animal drug application (NADA) was approved for that use.

On Sept. 7, 2011, FDA approved that NADA for PRASCEND Tablets containing pergolide mesylate. The tablets control the clinical signs associated with Cushing’s disease in horses, says FDA.

As a result of the recent approval for PRASCEND, FDA says it will no longer exercise enforcement discretion over the pharmacy compounding of pergolide for use in animals.