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"Black Box" Warning Issued for Reglan

Warning Issued for RegalnThe FDA has announced that manufacturers of the drug metoclopramide, most commonly found in Reglan, will now be required to include a boxed warning on their drug labels citing the medication's link to tardive dyskinesia. The FDA wants to notify patients and healthcare professionals about this risk so they can make more informed decisions about treatment options.

“Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, or 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.”


Reglan is used in the treatment of gastrointestinal disorders.It is available in several different varieties including tablets, syrup, and injection. The drug's current labeling warns of the risk of tardive dyskinesia associated with chronic use of the medication; however, the FDA's Center for Drug evaluation and research now contends that chronic use of metoclopramide therapy should be avoided in all but rare cases in which the benefits outweigh the risks.

The elderly, especially older women, and others who have taken the drug for an extended period of time are the greatest risk.

Reglan and other similar drugs containing metoclopramide are used by over 2 million Americans. According to recent published analysis, metoclopramide is the most common culprit for drug-induced movement disorders.

If you or a loved one is suffering from tardive dyskinesia and have taken the prescription drug Reglan we can help. For a free case evaluation by one our experienced defective drug lawyers please give us a call toll free at 1-866-LAW(529)-2400 or fill out the form on this page.