Jane S. Ricciuti, RPh, MS

Disclosures

March 19, 2003

In This Article

Central Nervous System Agents

Permax
(pergolide mesylate) Tablets

Manufacturer: Eli Lilly and Company

Drug Approval Classification: Original New Drug Application (Approval Date: 02/03/03)

Clinical Summary: In postmarketing surveillance of Permax (pergolide mesylate), a few patients had developed cardia valvulopathy (0.005%). The product labeling for Permax has been revised to include the following underlined wording to the "Warnings" section:

  • 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.

Permax (pergolide mesylate) Tablets Letter

Permax (pergolide mesylate) Tablets

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