The FDA issued the following announcement this afternoon. While removal of a drug from the market, especially after 20 years, is unusual, in this case the evidence supports this action. Many doctors have already been getting their patients off the drug, which has been associated with dangerous heart valve problems in recently published studies. Much to its credit, The FDA credit has sought the advice of patients in making this decision and in communications with the PD community.

Perry Cohen
Parkinson Pipeline Project
FDA Patient Representative


Dear Colleague:

The U.S. Food and Drug Administration (FDA) today announced that manufacturers of pergolide drug products, which are used to treat Parkinson’s disease, will voluntarily remove these drugs from the market because of the risk of serious damage to patients’ heart valves. FDA has issued a Public Health Advisory detailing the removal of pergolide products from the market.

The products being withdrawn are Permax, the trade name for pergolide marketed by Valeant Pharmaceuticals, and two generic versions of pergolide manufactured Par and Teva. Pergolide is in a class of medications called dopamine agonists and is used with levodopa and carbidopa to manage the symptoms (tremors and slowness of movement) of Parkinson's disease.

In 2006, an estimated 12,000 patients received prescriptions for pergolide from retail pharmacies in the United States. Patients taking pergolide should contact their doctors to discuss alternate treatments. Patients should not stop taking the medication, as stopping pergolide abruptly can be dangerous.

There are alternative therapies available for Parkinson’s disease, including three other dopamine agonists that have not been associated with valvular heart disease. The removal of pergolide products is not expected to adversely affect patient care because of the alternative therapies available.

For additional information, the press release and links to the Public Health are available at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01596.html.

FDA held a press conference today consisting of a short presentation by FDA officials followed by a question and answer session. The replay can be heard today after 4:00 pm EST by calling 1-800-944-3584, and it will be available for listening through April 2, 2007.

If you need additional information, please contact David Banks or Brenda Evelyn at 301-827-4460.

Sincerely,

David Banks, RPh., PhD.
Office of Special Health Issues
U.S. Food and Drug Administration
5600 Fishers Lane, Room 9-49
Rockville, Maryland 20857
David.Banks@fda.hhs.gov