Boxed warning about tardive dyskinesia added to metoclopramide label

FDA has stated that manufacturers of metoclopramide must add a boxed warning to their drug labels regarding the risk of tardive dyskinesia with long-term or high-dose use of this agent.

Metoclopramide is approved for the short-term treatment of gastroesophageal reflux disease (GERD) in patients who have not responded to other treatments and for the treatment of diabetic gastroparesis. This agent is available in tablet, oral solution, and injection formulations.

FDA has also announced that metoclopramide manufacturers must implement a risk evaluation and mitigation strategy (REMS) to ensure that patients are aware of the risk of tardive dyskinesia associated with this medication.

Metoclopramide was the subject of a recent California court case in which the court found Wyeth accountable for harms caused (in the form of tardive dyskinesia) in a patient who was treated with generic metoclopramide for nearly 4 years (see "California court: Wyeth accountable for harms caused by generic metoclopramide").