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Reglan
Tardive Dyskinesia
Reglan (metoclopramide) is a neuroleptic drug used to treat a number of gastrointestinal conditions including diabetic gastric stasis and gastric reflux, or heartburn. Long term use of Reglan may be linked to some psychiatric and/or neurological disorders (e.g., tardive dyskinesia).
The FDA approved the neuroleptic drug Reglan for short-term (not long term use) treatment of the above mentioned gastrointestinal conditions. However, evidence shows that one-third of patients are prescribed the neuroleptic drug Reglan for longer than 12 weeks, which violates FDA recommendations.
Studies have shown that the use of the neuroleptic drug Reglan can cause Tardive Dyskinesia in as many as 27% of its long-term users. According to the FDA, more than 2 million people have taken Reglan for gastrointestinal problems.
According to many reports, Reglan may have a number of serious psychiatric disorders and/or neurological disorders and side effects, including Tardive Dyskinesia.
U.S. FDA Action
On February 26, 2009, the FDA notified healthcare professionals that manufacturers of metoclopramide (reglan) must add a boxed warning (black box) to their neuroleptic drug labels.
For a summary of the black box warning for Reglan (metoclopramide), click here.
BOXED WARNING - Tardive Dyskinesia
Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose.
Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.
Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.
WARNINGS - Tardive Dyskinesia
Treatment with metoclopramide can cause tardive dyskinesia (TD), a potentially irreversible and disfiguring disorder characterized by involuntary movements of the face, tongue, or extremities. Although the risk of TD with metoclopramide has not been extensively studied, one published study reported a TD prevalence of 20% among patients treated for at least 12 weeks. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing TD.
Although the risk of developing TD in the general population may be increased among the elderly...
Metoclopramide should be discontinued in patients who develop signs or symptoms of TD...
Metoclopramide itself may suppress, or partially suppress, the signs of TD, thereby masking the underlying disease process...
The warning must inform users about the risk that long-term or high-dose use of Reglan has been linked to tardive dyskinesia (neurological disorder symptoms include lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, movement disorder or impaired movement of the fingers).
The FDA further stated that these neurological disorder symptoms are rarely reversible and there is no known treatment.
In addition, the FDA stated that current product labeling warns of the risk of tardive dyskinesia with chronic Reglan treatment and that those at the highest risk include the elderly, older women, and long term users of the neuroleptic drug Reglan.
FDA Video: Reglan
If you are taking the drug Reglan, or know someone who is, and developed a neurological side effect, please speak to a doctor immediately.
If you or a loved one has developed an illness/injury (side effects, neurological disorder, movement disorder - tardive dyskinesia (TD)) - because of Reglan, please contact us.
Please navigate to the links below to find more information on personal injury and what individuals suffering from a personal injury can do to protect their legal rights.
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