Permax was first launched in the U.S. in 1989 as a treatment in the management of signs and symptoms of Parkinson's disease and restless legs syndrome. In February 2003, the FDA issued a safety alert for the drug Permax because of the cardiac valvulopathy that was being observed in patients.

While the warning letter stated there had not yet been an established relationship found between the use of Permax and valvulopathy, the casual relationship was great enough to cause a labeling change to be required. It is still unclear if fibrotic valvular changes are related to retroperitoneal, pleural, and pericardial fibrosis, which is a very well known side effect of Permax. Patients with a history of these cardiac problems should be especially careful of using Permax.

If you or a loved one has been injured while taking Permax, please submit the accompanying form. You may be entitled to monetary awards for your injury!