Permax Removed From the Market

On March 29, 2007, the FDA announced that Permax (generic: pergolide) is being pulled off the market.  There are additional drugs in the same class that can be substituted, Dr. Robert Temple of the FDA's office of drug evaluation said at a briefing. To date, 14 patients have needed to have heart valves replaced, Temple said, adding he believes that is a miscalculation. He estimated that between 12,000 and 25,000 people currently using Permax are affected. Dr. Temple said withdrawal was demanded after two recent studies, published in The New England Journal of Medicine, indicated high rates of valve leakage; up to 20% in patients who were prescribed Permax.

Permax (Generic: pergolide) has been linked to serious heart damage. Cardiac valvulopathy involving one or more valves has resulted in some patients taking Permax. Permax is used to treat Parkinson's disease. Various medical experts have said, "Pergolide should be discontinued if valvular disease is detected and no other cause identified."

 FDA Announces Withdrawal of Parkinsons Drug from Market

Mar 30, 2007

The U.S. Food and Drug Administration (FDA) announced this week that all pergolide products are being removed from the market due to serious safety concerns. Pergolide drugs, which are used in the treatment of Parkinson's disease, have been connected with an increased risk of severe heart-valve damage. The products being withdrawn are Eli Lilly's Permax (marketed by Valeant Pharmaceuticals) and its generic counterparts made by Par and Teva. Pergolide is a dopamine agonist and is used in conjunction with levodopa and carbidopa to manage the symptoms (tremors, slowness of movement) of Parkinson's disease. Last year, roughly 12,000 patients in the United States received prescriptions for pergolide products.

"Based on important new drug safety information, FDA has been working with the manufacturers of pergolide products to voluntarily remove these drugs from the market," said Dr. Douglas Throckmorton, deputy director of FDA's Center for Drug Evaluation and Research. "The FDA's increased evaluation of post-market safety is benefiting the public because, in this case, as new data about the product became available, we were able to remove a less safe drug from the market."

The FDA approved Permax for Eli Lilly in 1988 as "an adjunctive therapy with levodopa" in the treatment of Parkinson's disease. According to the agency, evidence of the drug's connection to valvular heart disease first arose in 2002, and a warning about valvulopathy (abnormality of cardiac valves) was added to the product's label the following year. Last year, the FDA upgraded the alert to a black-box warning, their strongest type of warning, as new evidence poured in about the safety risks associated with pergolide.

According to the FDA, "Two recent New England Journal of Medicine studies confirm previous findings associating pergolide with increased chance of regurgitation (backflow of blood) 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."

The agency notes that patients should not abruptly stop using pergolide, but instead should consult their physicians to determine alternative therapies that may be available. There are three other dopamine agonists that have not been associated with cardiac-valve abnormalities.

If you have been harmed by Permax (Pergolide) contact a Dangerous Drug Attorney at Charlip Law Group, LC.  Click here to complete our free, confidential medical case evaluation form. A representitive will contact you promptly.  We can help you through this difficult time.

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