FDA Orchestrates Voluntary Recall of Parkinson's Disease Drug Permax

Action Follows News Of Studies Which Revealed Link To Serious Heart Valve Damage

(Posted by Tom Lamb at DrugInjuryWatch.com)

On March 29, 2007 the FDA announced that Permax as well as two generic pergolide drug products, which had been used to treat Parkinson’s disease, would be voluntarily removed from the U. S. market because Permax (pergolide) had been linked to serious heart valve damage.

From the FDA News item entitled "FDA Announces Voluntary Withdrawal of Pergolide Products":

The products being withdrawn are Permax, the trade name for pergolide marketed by Valeant Pharmaceuticals, and two generic versions of pergolide manufactured by Par and Teva.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 in a class of medications called dopamine agonists 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.

This move by the FDA follows two studies published in the New England Journal of Medicine (NEJM) as well as a more recent article published in the Archives of Neurology which seemed to confirm several previous studies that had associated Permax (pergolide) with an increased risk of developing regurgitation -- or backflow of blood -- of the mitral, tricuspid, and aortic valves of the heart. Generally, valvular regurgitation is a condition in which the heart valves do not close tightly which, in turn, allows blood to flow backward across the valves; common symptoms include shortness of breath, fatigue, and heart palpitations.

As one may recall, the two NEJM studies also discussed the association of another drug, Dostinex (cabergoline), with these heart valve side effects.  In a March 30, 2007 Wall Street Journal (WSJ) article, however, Dr. Robert Temple, director of the FDA's Offices of Drug Evaluation, said his agency is "not particularly worried" about Dostinex:

The two studies, published in January in the New England Journal of Medicine, also tied another Parkinson's drug, Pfizer Inc.'s Dostinex, or cabergoline, to heart-valve problems. In the U.S., FDA officials said, cabergoline is sold for a hormone condition, not for Parkinson's, and is recommended at far lower doses than the ones tied to the heart problems. Dr. Temple said the agency was "not particularly worried" about the drug.

Also from this March 30 WSJ article, it seems as if Eli Lilly & Co. disputes this FDA action concerning pergolide products, including Permax:

Eli Lilly & Co., which began marketing pergolide in the U.S. in 1989 and still sells it overseas, said it has no plans to pull it from foreign markets. The drug is "still an important treatment option for Parkinson's disease in Europe and around the globe," a spokesman for the Indianapolis company said. Eli Lilly believes "the risk-benefit profile of pergolide is still favorable" for certain patients when they follow the safety recommendations, he said.

In connection with this recall, the FDA has released a Public Health Advisory about Permax (pergolide) intended to provide information and recommendations to doctors, pharmacists, and patients in the wake of Permax being withdrawn from the market.