FDA Requires New Boxed Warning for Metoclopramide-Containing Drugs

The Food and Drug Administration recently announced that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken.

Manufacturers will be required to implement a risk evaluation and mitigation strategy (REMS) to ensure patients are provided with a medication guide that discusses this risk.

"The FDA wants patients and health care professionals to know about this risk so they can make informed decisions about treatment," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research. "The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk."

Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment. The development of this condition is directly related to the length of time a patient is taking metoclopramide and the number of doses taken. Those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time.

Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities; lip smacking, grimacing, tongue protrusion, rapid eye movements, or blinking; puckering and pursing of the lips; or impaired movement of the fingers. These symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.

Metoclopramide is available in a variety of formulations including tablets, syrups, and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. More than two million Americans use these products.

For information about the REMS, click here.

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