FDA Permax: Companies that manufacture and distribute pergolide have agreed to withdraw this drug from the market due to the potential for heart valve damage. Two new studies demonstrate 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. In 2006, a boxed warning regarding the risk of serious heart valve damage was added to the pergolide labeling. In light of this additional safety information and the availability of alternative treatments for Parkinson's disease that do not have comparable safety problems, the companies that manufacture and sell pergolide have stopped shipping pergolide for distribution and will, in cooperation with FDA, work to remove from the market both the name brand Permax (pergolide) and the generic versions of pergolide.
The effect of this voluntary withdrawal on supplies of pergolide currently in pharmacies will not be immediate. This delay will allow time for healthcare professionals and patients to discuss appropriate treatment options and to change treatments.
