Permax (chemical name: pergolide mesylate) manufactured by Eli Lilly and marketed by Valeant, was prescribed for patients with Parkinson's disease and also used off-label for Restless Legs syndrome. Permax was also sold generically by Par and Teva, as Pergolide. According to the Food & Drug Administration's MedWatch website, an estimated 500,000 people have used Permax since 1989.

SIDE EFFECTS:

Two studies published in the January 3, 2007 issue of the New England Journal of Medicine confirmed that the use of the Parkinson's drugs Permax (pergolide) and Dostinex (cabergoline) increases the risk of heart valve damage. Both studies indicated high rates of heart valve leakage - up to 20% - in patients taking the drug.

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. Drugs like Permax, Pergolide and Dostinex are known as dopamine agonists. They activate a cellular receptor known as 5-HT2b that can cause damage to the heart valve. Heart valve damage causes a reverse flow of blood that can lead to breathing problems, fatigue, and heart palpitations. If this condition is not surgically fixed, it can lead to heart failure and sudden death.

LITIGATION:

Initially Eli Lilly, the maker of the drug, claimed that Permax has had a safe record since coming on the market, but that the company would consider adding information about this heart risk to the label. In 2003, the FDA asked the drug company to add 'abnormality of cardiac valves' to the warnings section of Permax labeling. In 2006, that warning was upgraded to a black box warning because of more reports of patients suffering heart valve damage. In March 2007, the FDA issued a Public Health Advisory (PHA) detailing the removal of pergolide products from the market

Dr. Abraham Lieberman, the medical director of the National Parkinson Foundation in Miami, was one of the doctors who studied Pergolide in the 1980s when it was developed. "There is evidence of pulmonary fibrosis that is associated with Pergolide," he says, "but there's a 14-year history of people taking Permax, and why hasn't this showed up sooner?"

The pharmaceutical company's failure to warn about the dangers associated with Permax is a serious violation of your rights as a consumer. If you or a loved one has developed heart valve damage after taking Permax, you may be entitled to compensation for your injury. To find out more information, fill out the form on the right and an experienced Permax attorney will contact you to discuss your rights.