October 15, 2009

 

 FDA providing guidance on use of drug for Cushing disease

posted October 1, 2009
 

Federal drug authorities are providing guidance for veterinarians on the use and compounding of a drug used in the treatment of hyperadrenocorticism (Cushing disease) in dogs.

The Food and Drug Administration published online a letter to veterinarians Sept. 11 that states Vetoryl is the only FDA-approved animal drug containing trilostane as the active ingredient. The letter also states the drug should not be imported from other countries, should not be compounded in bulk, and can be legally compounded only if Vetoryl is used as the starting material.

"An animal drug that is compounded from bulk drug ingredients is not FDA-approved and the safety and effectiveness of the compounded drug, as well as the adequacy of the manufacturing process, have not been evaluated," the letter states.

Laura Alvey, a spokeswoman with the FDA Center for Veterinary Medicine, said CVM officials think it is important to educate not only veterinarians but also pharmacists on the approved product. The FDA wrote a letter to pharmacists similar to the letter to veterinarians.

The FDA announced May 11 the approval of Vetoryl for treating pituitary- and adrenal-dependent hyperadrenocorticism.

The drug is produced by Penn Pharma in South Wales, U.K., and distributed by Dechra Veterinary Products of Overland Park, Kan.

The FDA Center for Veterinary Medicine's letter to veterinarians is available at www.fda.gov. Click on the "Animals and Veterinary" tab, then on "Safety and Health," and "Letters to Veterinary Professionals."