The FDA today withdrew the Parkinson's disease drug pergolide -- a dopamine agonist sold as Permax and as a generic -- because of an increased risk of valvular heart disease.

Robert Temple, M.D., associate director for medical policy at the Center for Drug Evaluation and Research, said pergolide associated with fivefold relative increase in regurgitation of the mitral, atrial, or tricuspid valves compared with the general population.

Dr. Temple said the drug, which was approved in 1988, is used by a minority of Parkinson's patients, an estimated 12,000 to 25,000 patients. Permax is manufactured by Valeant Pharmaceuticals and generic versions of the drug are made by Par and Teva.

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