Boxed Warning Added to Metoclopramide-Containing Drugs

Emma Hitt, PhD


February 27, 2009

February 27, 2009 — Metoclopramide (Reglan, Alaven Pharmaceutical, and generics) has been linked to irreversible tardive dyskinesia directly related to the length of treatment and the number of doses taken. Manufacturers must add a boxed warning to their drug labels about this risk, the US Food and Drug Administration (FDA) says.

Manufacturers will also be required to implement a risk evaluation and mitigation strategy "to ensure patients are provided with a medication guide that discusses this risk," the FDA notes in a news release.

Current product labeling already warns of the risk for tardive dyskinesia with chronic metoclopramide treatment. The new boxed warning will specifically highlight the risks associated with long-term, high-dose use, according to an alert from MedWatch, the FDA's safety information and adverse event reporting program.

"Chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk," says Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, in an FDA press release.

Metoclopramide is the most common cause of drug-induced movement disorders. In one study, the FDA determined that about 20% of patients had been taking the drug for more than 3 months. Ongoing reports of spontaneous tardive dyskinesia in patients using metoclopramide, the majority of whom had taken the drug for more than 3 months, have also been reported.

In some patients, symptoms, which include involuntary, repetitive movements of the extremities, may decline after cessation of treatment; however, tardive dyskinesia is rarely reversible, and no known treatment is available. Patients at greatest risk for tardive dyskinesia include women and the elderly, the FDA says.

Metoclopramide is indicated for short-term treatment of gastroesophageal reflux disease in patients who do not respond to other therapy and is also used to treat symptoms of diabetic gastroparesis.

Metoclopramide-containing products include Reglan tablets, Reglan oral disintegrating tablets, Reglan injection, and metoclopramide oral solution.

Adverse events related to use of metoclopramide should be communicated to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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