Sales of Permax, a once-popular drug prescribed for the treatment of Parkinson’s disease and restless leg syndrome, will no longer be sold in Canada as of August 30, 2007, according to a joint announcement by Eli Lilly Canada and Health Canada, the Canadian equivalent of the FDA, on August 16, 2007. The recall by the Canadian government follows the withdrawal of Permax from the United States market by the FDA on March 29, 2007, after concluding that the risks of Permax-induced heart valve damage outweighed the benefits of the medication.
Permax, also known as pergolide mesylate, was first approved in the United States in 1989 and in 1991 in Canada. Eli Lilly developed Permax which was then licensed for marketing to Valeant Pharmaceuticals and Shire Pharmaceutical. Teva also manufactures a generic version. An estimated 500,000 patients in the United States took Permax and pergolide mesylate, but the number of prescriptions dropped dramatically in 2002 when safety concerns about the drug first arose. Several studies have concluded that patients using Permax have an increased risk of developing heart valve damage. The type of damage associated with Permax is similar to that seen in patients who have ingested various ergotamine-derived medications and the type of heart valve damage documented in users of the diet drugs, Pondimin, fenfluramine, and fen-phen. The latest studies from the New England Journal of Medicine published in January of 2007 noted that patients who ingested Permax for more than six months were at the greatest risk for this harm. Patients have been urged to consult with their physcians regarding the proper manner for weaning themselves from Permax in order to avoid serious complications. Patients may also require a cardiac evaluation and echocardiogram to determine whether they have sustained heart valve damage. The law firm of Alley, Clark, Greiwe & Fulmer has litigated claims involving medication-induced heart valve damage for a decade, including the successful representation of over 1,200 clients from the Tampa Bay area and throughout Florida who suffered heart and lung injuries as a result of their ingestion of diet drugs.
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