March 30, 2007
Manufacturers of the Parkinson's disease drug pergolide have agreed to pull it from the US market because it increases the risk of serious heart valve damage, US drug regulators said.
The products being withdrawn are Permax, marketed by Valeant Pharmaceuticals, and two generic versions manufactured by the pharmaceutical companies Par and Teva, the US Food and Drug Administration (FDA) said.
Pergolide is used in combination with two other drugs to manage tremors and slowness of movement.
"Two new studies showed that patients with Parkinson's disease who were treated with pergolide had an increased chance of serious damage to their heart valves when compared to patients who did not receive the drug," the FDA said in a public health advisory posted online Thursday.
The FDA warned patients not to abruptly stop taking the drug as doing so can be dangerous. Patients should contact their doctors to discuss alternative treatments, it said.
Two New England Journal of Medicine studies confirm previous findings associating pergolide with valve regurgitation, a condition in which valves do not close tightly, allowing blood to flow backward across the valve, the FDA said.
"In light of this additional post-market safety information, the companies that manufacture and sell pergolide will stop shipping pergolide for distribution and, in cooperation with FDA, will withdraw the products from the market," the FDA said in a statement.
"The removal of pergolide products is not expected to adversely affect patient care because of the alternative therapies available," it said.
An estimated 12,000 patients were given pergolide prescriptions in the United States last year, the FDA said.