FDA Statement on Compounding of Pergolide Products for
Animal Use
March 16, 2012
On September 7, 2011, the U.S. Food and Drug Administration (FDA or Agency)
approved a new animal drug application (NADA) for a product containing pergolide
mesylate (NADA 141-331) marketed under the trade name PRASCEND Tablets for the
control of the clinical signs associated with Cushing’s Disease in horses.
In the past, veterinarians prescribed human pergolide products to treat
Cushing’s Disease in horses under the “extralabel” use provisions of the Federal
Food, Drug, and Cosmetic Act. However, in May 2007, the human pergolide products
were removed from the market due to concerns about cardiac side effects in
humans. At that time FDA stated that it would work with the sponsors of approved
human products and others to ensure that pergolide remained available to treat
Cushing’s Syndrome in horses until a new animal drug application was approved
for that use. FDA stated that this would include, among other things, exercising
enforcement discretion as appropriate over the pharmacy compounding of pergolide
for use in animals. However, because FDA has approved NADA 141-331, the
conditions under which the Agency was exercising enforcement discretion no
longer exist.
For additional information, click
here.