Cabergoline

Status

FDA-approved. FDA-approved labeling exists for treatment of hyperprolactinaemic disorders, either idiopathic or due to pituitary adenomas. Labeling covers cardiac valvulopathy, fibrotic complications, impulse control disorders, orthostatic hypotension and somnolence. It is contraindicated in uncontrolled hypertension and in patients with a history of cardiac valvular disorders.

What it is

A dopamine agonist that lowers prolactin, approved for specific disorders.

What published research measured

A long-acting dopamine D2 receptor agonist with strong randomized evidence in hyperprolactinaemia and prolactinoma, where it normalizes prolactin and shrinks tumours more effectively and with better tolerability than bromocriptine. Its half-life allows weekly or twice-weekly administration. The safety finding that shaped its labeling comes from Parkinson's disease, where the much higher daily doses used were associated with cardiac valvular fibrosis through serotonin 5-HT2B receptor activity; at the far lower doses used for prolactin disorders the risk appears low, and guidance generally recommends echocardiographic surveillance for long-term or higher-dose use. Impulse control disorders — pathological gambling, hypersexuality, compulsive spending — are a documented dopamine agonist class effect that patients are frequently not warned about and may not connect to the drug.

Source

FDA labeling for cabergoline, including valvulopathy and impulse control disorder warnings

Sources

• Half-life source for Cabergoline