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.
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.
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.
Quite frankly, the simple factsTM about the drug Reglan and the possible injuries or other neurological health complications (e.g., tardive dyskinesia (TD) that may be caused by taking Reglan for prolonged periods or long term use are unacceptable.
We are investigating claims of Tardive Dyskinesia, neurological disorders, movement disorder(s) and other health problems in connection with possible side effects and problems from the use (long term use) of the drug Reglan.
We are here to help you protect your legal rights and the legal rights of your loved ones.
