Revisiting the Incidence of Tardive Dyskinesia With Oral Metoclopramide Use: A Real-World Epidemiology Study...

Gastroparesis is a debilitating disorder with limited treatment options, and metoclopramide remains the only FDA-approved pharmacologic therapy. Concerns about metoclopramide-induced tardive dyskinesia (TD) are based on older studies with inconsistent incidence estimates (1%-15%). A reassessment of metoclopramide's TD risk is needed.

A retrospective cohort study using the MarketScan Research database analyzed TD incidence in adults (2011-2020) with at least 12 months of medical and pharmacy benefits. TD rates were compared among metoclopramide-treated gastroparesis patients, those untreated, and the general population. Poisson regression models adjusted for person-years (p-yrs) at risk.

The incidence of TD among metoclopramide-treated gastroparesis patients was 159.4 per 100,000 p-yrs (0.37%), notably lower than guideline estimates (1%-15%). Comparatively, TD incidence was 121.3 (0.26%) in untreated gastroparesis patients, 51.4 (0.12%) among all metoclopramide users, and 7.6 (0.02%) in the general population. Higher TD rates were observed in older adults (≥ 65 years), females, and in patients with prolonged metoclopramide use, diabetes, psychiatric conditions, Parkinson's disease, or concurrent use of dopamine receptor-blocking agents. Adjusted analyses found no significant independent association between metoclopramide use and increased TD risk in gastroparesis patients.

TD incidence is uncommon with metoclopramide use and lower than previously estimated in gastroparesis patients. These findings suggest metoclopramide may be a viable treatment option and warrant a reassessment of its risk-benefit profile in gastroparesis management.