Manufacturer: Eli Lilly and Company Rationale for Labeling Revision: During postmarketing surveillance for pergolide, one of the ergot alkaloids, cardiac valvulopathy was found to involve one or more valves in a small number of patients during therapy. Based on Eli Lilly’s safety data and scientific publications, the pathological assessment of the surgically removed valves was consistent with the valvulopathy associated with carcinoid syndrome and with the use of other ergot alkaloid drugs. Although a clear causal relationship between pergolide and the valvulopathy in these patients could not be established, given the nature of the lesions and the known similar effects of other ergots, the warnings section of the package insert for pergolide was modified to reflect these data.

In the published reports, the aortic, mitral, and tricuspid valves were affected. In some cases, symptoms or manifestations of valvulopathy improved with cessation of pergolide therapy. Two patients required valve replacement. Indications: Pergolide mesylate, a dopamine receptor agonist, is used with levodopa or with a carbidopa-levodopa combination to treat patients with Parkinson’s disease, a progressive neurological disorder resulting from the degeneration of neurons in a region of the brain that controls movement. Per-golide mesylate works by stimulating certain parts of the central nervous system that are involved in this disease. In deciding whether or not to use pergolide mesylate, prescribers must weigh the risks associated with the drug against the benefits it confers. cialis canadian pharmacy

Warning Label Change

Serous Inflammation and Fibrosis

There have been rare reports of pleuritis, pleural effusion, pleural fibrosis, pericarditis, pericardial effusion, cardiac valvu-lopathy involving one or more valves, and retroperitoneal fibro-sis in patients taking pergolide. In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of therapy. Pergolide should be used with caution in patients with a history of these conditions, particularly in patients who experience these events while taking ergot derivatives. Patients with a history of such events should be carefully monitored clinically and with appropriate radiographic and laboratory studies during pergolide therapy. Conclusion: Mayo Clinic physicians have recently issued a report warning that pergolide mesylate, when used to treat Parkinson’s disease, might cause serious damage to the heart valves, similar to the damage caused by the diet drug “Phen-fen,” a combination of phentermine with fenfluramine (Pondimin®) or dexfenfluramine (Redux™), both from American Home Products/Wyeth. From this observation, it is recommended that all patients taking pergolide mesylate undergo a thorough cardiovascular examination. The evidence in the report is based on only three patients treated at the clinic, but the physicians consider their evidence sufficient to recommend that patients with heart problems not take pergolide. Pergolide has been used since 1989 to treat the tremors and restless legs syndrome that affect patients with Parkinson’s disease. The physicians urge that pergolide be discontinued if valvular disease is detected and if no other cause is identified.