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Permax™
An article in the January 4, 2007 issue of the New England Journal of Medicine revealed that Eli Lilly drug Permax (Pergolide) significantly increases the risk of developing valvular heart problems in users with Parkinson's disease. Two recent studies of the drug, which is also used to treat restless leg syndrome, found that users were at least seven times more likely to develop valvular heart damage than those taking other Parkinson's treatments; patients taking the highest Permax doses were at a 37 times greater risk of developing heart damage. The heart damage experienced by study participants ranges from moderate valve damage and leaky valves to heart failure and sudden death.
Permax entered the market in 1989. In 2003, Eli Lilly sent out a Dear Health Care Professional Letter indicating that post-marketing surveillance showed that some users of the drug developed cardiac valvulopathy. The manufacturer thereafter added a warning to its product label stating:
Serous Inflammation and Fibrosis-- There have been rare reports of pleuritis, pleural effusion, pleural fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy involving one or more valves, or retroperitoneal fibrosis in patients taking pergolide. In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of pergolide. Pergolide should be used with caution in patients with a history of these conditions, particularly those patients who experienced the events while taking ergot derivatives. Patients with a history of such events should be carefully monitored clinically and with appropriate radiographic and laboratory studies while taking pergolide.
Approximately 500,000 patients have used Permax since its introduction to the market in 1989. In 2006, Permax sales amounted to more than $10 million in the United States. Although manufactured by Eli Lilly, the rights to Permax in the U.S. now belong to Valeant Pharmaceuticals of Aliso Viejo, California.
Dostinex™
In the same New England Journal study, users of Pfizer drug Dostinex (Cabergoline) were found to be 4.9 times more likely to suffer heart problems than patients taking similar drugs. At the highest doses, the probability of experiencing valvular damage rose to 50.3 times greater for Dostinex users. In the United States, Dostinex is marketed only for a hormonal disorder, hyperprolactinemia, but is marketed for Parkinson's outside the country. Currently, the Dostinex package insert and label lists heart valve damage only as a "precaution."
About Parkinson's Disease
Parkinson's disease is a progressive neurological disorder resulting from the degeneration of neurons in a region of the brain that controls movement. The degeneration creates a shortage of the brain-signaling chemical known as dopamine, causing the movement impairments that characterize the disease. In the United States, at least 1 million people are believed to suffer from Parkinson's disease, and about 50,000 new cases are reported annually.
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