On Feb. 26, 2009, FDA warned against the long-term use of drugs that contain Reglan (metoclopramide). Metoclopramide is approved for the short-term (no longer than 3 months) treatment of gastrointestinal disorders, such as gastroesophageal reflux disease (GERD) in people who haven’t responded to other treatments, and to treat diabetic gastroparesis (slowed emptying of the stomach’s contents into the intestines). The drug 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.

Adverse events: Frequent and long-term use of metoclopramide has been linked to tardive dyskinesia, a disorder that causes uncontrollable, repetitive movements of the body such as lip smacking, grimacing, tongue protrusion, puckering and pursing of the lips, rapid eye movements or blinking, and rapid movements of the fingers, arms, legs, and trunk.

People at risk: Those at greatest risk include elderly people, especially older women, and people who have been on the drug for a long time The U.S. Food and Drug Administration announced today 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.

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