Nationwide Recall Of Permax (Pergolide) Issued

M. Brandon Smith

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The United States Food and Drug Administration has issued a public health announcement concerning the withdrawal of Permax (Pergolide) from the market due to a link of increased heart valve damage in its consumers. The advisory indicates two new studies showed patient's with Parkinson' Disease, who ingested pergolide, were at a higher risk of developing cardiovascular problems than those who did not take pergolide. Pergolide is commonly used to manage the symptoms of Parkinson's Disease and is a member of the dopamine agonists drug class. Anyone with Permax (Pergolide) is directed to stop taking the drug immediately in order to prevent any further injury.

According to the FDA:

In 2006, a boxed warning regarding the risk of serious heart valve damage was added to the labeling for pergolide. The two recent studies, published in The New England Journal of Medicine in January 2007, confirm earlier studies that also described this problem. Pergolide is marketed by Valeant under the trade name Permax and sold and manufactured as the generic drug pergolide by Par and Teva.

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.