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An FDA Warning About Metoclopramide

Metoclopramide requires a boxed warning about risk for tardive dyskinesia.

In February 2009, the FDA announced that manufacturers of metoclopramide must add a boxed warning (black box) on drug labels to warn providers and patients about the risk for tardive dyskinesia (TD) with chronic or high-dose use. Metoclopramide increases the rate of stomach emptying and is used as short-term treatment (<3 months) for gastroesophageal reflux and gastroparesis in patients who do not respond to other treatments. The director of the FDA’s Center for Drug Evaluation and Research commented that although the FDA wants patients and health professionals to be able to make informed decisions regarding treatment, chronic use of metoclopramide should be avoided, except in rare circumstances in which benefit outweighs risk.

TD is characterized by involuntary, repetitive movements of the limbs; lip smacking; tongue protrusion; eye movements and blinking; puckering of the lips; and impaired movement of the hands. No treatment exists, and symptoms are rarely reversible, although they might lessen or resolve after the drug is stopped. Development of TD is related to duration of treatment and number of doses taken. Older women and patients who have received the drug for more than 3 months seem to have the highest risk.

Comment: Metoclopramide is a commonly used drug, and this warning will reduce its use. If a clinician chooses to treat a patient with metoclopramide, duration of treatment should not exceed 3 months, patients should be informed about the risk for TD, and the drug should be stopped at the first sign of symptoms. Use of metoclopramide in infants must be monitored closely because early signs of TD might be difficult to identify.

— William P. Kanto, Jr., MD

Published in Journal Watch Pediatrics and Adolescent Medicine March 18, 2009

Citation(s):

FDA requires boxed warning and risk mitigation strategy for metoclopramide-containing drugs [press release]. Rockville, MD: Food and Drug Administration; Feb 26 , 2009. (http://www.fda.gov/bbs/topics/NEWS/2009/NEW01963.html)

Reader Remarks:

Review and add to remarks on this article

• What Is the Mechanism of Action?
  NASIMUL H SIDDIQUI, MD, 26 Mar 2009 11:10 AM EST
  Td is related to chronic use of metoclopramide but still it is unexplained why chronic use cause this.
• Metoclopramide's Mechanism of Action
  William P. Kanto, Jr., MD, Associate Editor, Journal Watch Pediatrics and Adolescent Medicine, 26 Mar 2009 5:23 PM EST
  Behavioral, motor, and neuroendocrine effects of metoclopramide have been linked to its antidopaminergic activity.

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