Reglan® is a prescription drug designed for the short-term treatment of gastro-esophageal reflux. In addition, Reglan® can be prescribed to patients with diabetic gastro-paresis – a condition that slows down gastric emptying, and which can result in intense heartburn, nausea and vomiting.
However, despite its effectiveness at treating gastro-esophageal reflux, some studies have shown that the Reglan® drug can put patients at risk of developing serious and potentially fatal side effects.Â
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Reglan® Drug
Side-effects associated with the Reglan® drug include (a) Neuroleptic Malignant Syndrome - a potentially fatal condition that can cause kidney damage, muscle-rigidity, delirium, fever, serious fluctuations in blood-pressure, and coma; and (b) Tardive dyskinesia, a neurological condition that can result in involuntary and rapid movement in the arms and legs; uncontrollable grimacing; rapid eye blinking; and tongue protrusion.
On February 26, 2009, the FDA issued the following:
"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.
"Manufacturers will be required to implement a risk evaluation and mitigation strategy, or 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 the 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, 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.
"Metoclopramide works by speeding up the movement of the stomach muscles, thus increasing the rate at which the stomach empties into the intestines.
"It is used as a short-term treatment of gastroesophageal reflux disease in patients who have not responded to other therapies, and to treat diabetic gastroparesis (slowed emptying of the stomach's contents into the intestines). It is recommended that treatment not exceed three months.
"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.
"Recently published analyses suggest that metoclopramide is the most common cause of drug-induced movement disorders. Another analysis of study data by the FDA showed that about 20 percent of patients in that study who used metoclopramide took it for longer than three months.
"The FDA has also become aware of continued spontaneous reports of tardive dyskinesia in patients who used metoclopramide, the majority of whom had taken the drug for more than three months."
If You Have Been Injured by Reglan®
Have you or a loved one been injured after taking Reglan®?
If so, contact DrugRxRecall to speak with an experienced Reglan® lawyer who specializes in drug recall litigation & lawsuits. For a free evaluation of your potential claim, call 1-888-446-8087, or fill out an intake form on this website by clicking on "Can We Help You?" on the upper right hand corner of the home page.
Let DrugRxRecall help you win the compensation you need and deserve.
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