Permax

Cardiac Valvulopathy and Fibrotic Complications

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 (seeDOSAGE & 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...