Drug Recall: Permax Removed from Market

On March 29, 2007 the FDA announced the recall of Permax and other generic forms of the ingredient pergolide. These medications have been used successfully in the United States for many years for the treatment of Parkinson's Disease. After further study, however, this ingredient has been linked to serious heart valve damage.

Permax (the brand name of this product marketed by Valeant Pharmaceuticals) and two generic versions marketed by Par and Teva are widely used in the United States. The ingredient pergolide is in a class of medications referred to as dopamine agonists. This is often used with levodopa and carbidopa (marketed as Sinemet and other generic combinations) to manage symptoms of Parkinson's Disease.

The FDA decided to take this action following several studies published in the New England Journal of Medicine that indicated certain heart problems linked to usage of this drug. There is apparently an increased risk of developing a backflow or regurgitation of blood within several valves of the heart. This usually occurs when the valves malfunction or are no longer capable of closing fully. This results in blood being able to flow backward through the unclosed valve.

Patients who are currently being treated with this medication may find themselves in a tough spot. They need to contact their healthcare providers immediately to discuss options. These patients are also advised to NOT stop use of this medication before consulting their healthcare provider. There are serious consequences to stopping this medication suddenly and there are other treatments available that can be gradually started before pergolide treatment is stopped.

Healthcare professionals need to determine if a patient is still in need of treatment with Dopamine agonist therapy. If this treatment is deemed necessary, there are several other medications available to treat Parkinson's Disease without the apparent risk for heart damage. As stated earlier, pergolide should not be stopped suddenly. The dose should be gradually decreased before discontinuing.

Since this information has been released, the companies that currently market Permax and generic forms of pergolide have stopped shipping these medications. They are currently working with the FDA to remove these from the market completely. However, this is still considered a voluntary recall. The stock currently in pharmacies is not required to be returned. The availability of this item will gradually diminish and will not be replaced. Hopefully, this delay will allow proper discussion between patients and healthcare providers and time for the gradual stopping of this medication by patients.