Cardiac Valvulopathy

• The use of pergolide has been shown to increase the risk of cardiac valvular disease involving one or more valves.
• Some patients have required valve replacement, and deaths have been reported. Cases have been reported after exposures to pergolide ranging from several months to several years.
• The histopathology of explanted valves is similar to that of other drug-induced valvulopathies. Precise risk estimates of pergolide-induced cardiac valvular disease are not available.
• Specific risk factors predisposing patients to developing cardiac valvular disease with pergolide have not been identified. Cardiac valvulopathy has been reported with all doses of pergolide; however, available data suggest that the risk may be greater with higher doses. Doses of pergolide above 5 mg/day are not recommended (see DOSAGE & ADMINISTRATION).
• Pergolide is not recommended for use in patients with a history of cardiac valvulopathy. Before initiating treatment with pergolide, all patients should undergo a cardiovascular evaluation, including an echocardiogram, to determine whether valvular disease is present and to provide a baseline for subsequent monitoring.
• Although the risk of disease progression in patients with asymptomatic valvular disease is unknown, pergolide ordinarily should not be initiated if valvulopathy is detected at screening.
• All patients taking pergolide should undergo periodic echocardiograms to screen for the development of valvulopathy. Patients should also be monitored for signs and symptoms of valvulopathy, including dyspnea, edema, congestive heart failure and new cardiac murmurs. If a patient develops these signs or symptoms, consideration should be given to suspending treatment with pergolide until a full diagnostic evaluation, including echocardiogram, has been performed.
• Pergolide should ordinarily be discontinued if a patient is diagnosed with cardiac valvular disease. In some cases, signs and/or symptoms of cardiac valvulopathy improved after discontinuation of pergolide.

Fibrotic Complications

• Case reports have demonstrated that pergolide increases the risk of fibrotic complications including pulmonary, pleural, and/or retroperitoneal fibrosis, pericarditis,pleuritis, and pericardial and/or pleural effusions.
• Cases have been reported after exposures to pergolide ranging from about one to several years.
• Precise risk estimates of pergolide-induced fibrotic complications are not available.
• Specific risk factors predisposing patients to developing fibrotic complications with pergolide have not been identified. Fibrotic complications have been reported with all therapeutic doses of pergolide.
• Pergolide is not recommended for use in patients with a history of fibrotic conditions.
• Patients should also be monitored for signs and symptoms of fibrotic complications, including dyspnea, persistent edema, cough, congestive heart failure, new cardiac rub, and/or signs of urinary tract obstruction. If a patient develops these signs or symptoms, consideration should be given to suspending treatment with pergolide until a full diagnostic evaluation has been performed.
• Pergolide should ordinarily be discontinued if a patient is diagnosed with a specific fibrotic complication. In some cases, signs and/or symptoms of fibrotic complications improved after discontinuation of pergolide.