The FDA ( Food and Drug Administration ) 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.

The products being withdrawn are Permax, the trade name for Pergolide marketed by Valeant Pharmaceuticals, and two generic versions of Pergolide manufactured by Par and Teva.

Pergolide is a dopamine agonist 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.

Two recent New England Journal of Medicine studies confirm previous findings associating pergolide with increased chance of regurgitation of the mitral, tricuspid, and aortic valves of the heart. Valve regurgitation is a condition in which valves don’t close tightly, allowing blood to flow backward across the valve. Symptoms include shortness of breath, fatigue and heart palpitations.

Permax was approved in 1988 for Eli Lilly and Company as an adjunctive therapy with Levodopa in Parkinson’s disease.
Valvular heart disease was first described in association with Pergolide in 2002.
In 2003, FDA asked Lilly to add valvulopathy to the warnings section of Permax labeling, at which time a Dear Healthcare Practitioner letter was sent by Lilly. In 2006, the warning was upgraded to a black box warning, the FDA’s strongest form of warning, because of new data concerning risks of heart valve damage.

Source: FDA, 2007


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