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Reglan has been used in the U.S. since 1980 and is a drug containing metoclopramide that is used for the treatment of gastrointestinal disorders. The metoclopramide drug works by increasing stomach muscle movement which speeds up the rate of the stomach empting into the intestines.
Reglan will now be black boxed with a warning of its link to a movement disorder called tardive dyskinesia. The Food and Drug Administration issued the requirement in February of 2009 that a “black box” warning be placed on the Reglan and stated that Reglan and other heart burn drugs that contain metoclopramide can cause the neurological problem when taken in high doses or when taken over a long period of time. More than 2 million people use Reglan and metoclopramide drugs like it. The drugs are meant for short-term use in patients that have not responded to other therapies for the treatment of gastroesophageal reflux disease.
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Diabetic gastroparesis is also treated with these medications. Treatment should not exceed three months with these medications although an analysis of study data by the FDA showed that about 20 percent of metoclopramide using patients used for longer than the advised 3 month period. The FDA also stated that there have been continued reports of tardive dyskinesia and that the majority of the reports include patients that use the drug for more than three months.
Tardive Dyskinesia is defined by the repetitive and involuntary movements of the extremities including rapid eye movements, grimacing, lip smacking, puckering and pursing of the lips, and impaired finger movement. There is no known treatment for these symptoms and they are rarely reversible although symptoms may lessen or resolve in some patients after the treatment with metoclopramide is stopped. The elderly, mostly older women and people who have been on the drug for a long time are at the greatest risk of developing Tardive Dyskinesia.
The Black Box is the Food and Drug Administration’s strongest safety warning. In addition to Reglan and similar drugs being Black Boxed, the FDA is also requiring that a risk evaluation and mitigation strategy(REMS) be implemented by the makers of metoclopramide containing drugs to ensure that a medication guide is provided to patients that discusses the of using these medications over a long period of time or in high doses.
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