February 27, 2009
FDA issues metoclopramide warningThe FDA has notified healthcare professionals that the manufacturers of metoclopramide will add a boxed warning regarding the risk of its long-term or high-dose use. Chronic use has been linked to tardive dyskinesia even after the drugs are no longer taken. Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment. Marketed metoclopramide products include Reglan tablets (from Alaven) and Reglan injection (from Baxter).
Metoclopramide is indicated for the treatment of symptomatic refractory GERD and nausea and vomiting associated with diabetic gastroparesis.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm106942.htm.