Information on Reglan® Medication
Reglan® is a prescription medication that is specifically designed for the short-term treatment of gastro-esophageal reflux. Additionally, Reglan® medication can be prescribed to patients suffering from diabetic gastro-paresis – a condition that has the effect of slowing down gastric emptying, which may result in intense heartburn, nausea and vomiting.
Medication and Side-Effects
Reglan® medication works by increasing the frequency of muscle contractions in the upper digestive tract of the patient, with the intention of increasing the speed at which the contents of the stomach are emptied into the intestines.
There are, however, several serious, potential side-effects that may result from taking the medication Reglan®, including Neuroleptic Malignant Syndrome - a potentially deadly condition that may result in kidney damage, muscle-rigidity, delirium, fever, unstable blood-pressure, and coma.
Tardive dyskinesia - a neurological condition - has been reported in some patients taking the medication Reglan®. The most serious symptoms of Tardive dyskinesia include involuntary and rapid movement in the patient’s arms and legs; involuntary grimacing; excessive and rapid eye blinking; as well as tongue protrusion. Of equal seriousness: the patient may experience the above side effects associated with Tardive dyskinesia long after the course of treatment with Reglan has been completed.
The Food and Drug Administration (FDA) released the following statement in February 2009:
"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."
Contact Us
If you or a loved one has suffered from serious, life-threatening conditions that may have resulted from taking the medication Reglan®, contact DrugRxRecall immediately.
After you contact us, we will be very pleased to refer you to a skilled, highly motivated and experienced lawyer who can offer you a free consultation on potential claims for accidents, injuries and deaths that may have been caused by the side-effects of the medicaton Reglan®.
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