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Lawyers for Reglan, FDA Warnings for Reglan, Tardive Dyskinesia

Written by Class Action Lawyer on . Posted in Class MDL Class Action News, Drug Warnings

What is Reglan (Metoclopramide)? A. H. Robins Co. Reglan Metoclopramide
Reglan (metoclopramide) is a prescription drug often prescribed to treat gastrointestinal problems in children and adults. Reglan is most often used to control gastroesophageal reflux disease (GERD), or to reduce nausea and vomiting.  Physicians will often use Reglan for both children and adults suffering from reflux, gastroparesis, and other conditions related to the stomach such as heartburn, decreased appetite, and prolonged fullness after eating.  Even infants are sometimes given Reglan for reflux.
Reglan works by affecting the lower esophageal sphincter pressure, which then helps to improve gastrointestinal emptying.  The FDA has only approved Reglan for short-term treatment (between 4 and 12 weeks) of these conditions, and  only after conservative methods of treatment have failed.  Unfortunately, prescription trends prove that many patients are prescribed Reglan for longer than 12 weeks (often for years), which is against FDA recommendations.  The manufacturers of Reglan are well aware of these extended prescription trends.
Medical science and studies have proven that Reglan can cause Tardive Dyskinesia, a serious and often irreversible movement disorder.  Infants who are given Reglan appear to be at an even greater risk for this serious drug side effect.

FDA Issues Advisory for Reglan
In February 2009, the FDA issued an advisory, that forces the manufacturers of Reglan (MCP) to update their label. The advisory calls for a "black box" warning – the strongest warning that the FDA can issue. The advisory (and the proposed black box warning) are attached here … In addition, the FDA has requested that the drug companies send Dear Doctor letters – enclosing the new label and the new warning. This also is one of the strongest ways the FDA can spread the word – both to doctors and to patients taking Reglan.

What is GERD or Reflux?
For infants, it is often called reflux, short for the medical term gastroesophageal reflux (GER).  It is a common condition in infants, and typically resolves between six and twelve months of age.  Infants with reflux will often spit up after feeding, and have difficulties taking in enough nutrition.  Many babies suffer from reflux, and rarely need treatment.  Some, however, do receive Reglan for treatment.
For adults, the symptoms usually progress to a greater set of problems, such as chronic heartburn, decreased appetite, or the more difficult issues of constant nausea and vomiting.  Treatment with Reglan is intended to last for 4 to 12 weeks.  Many doctors are unaware of this recommendation, and end up prescribing Reglan for significantly longer periods.  This can have terrible consequences for the patient.
As with any medication, a detailed risk/benefit discussion with your doctor is critical.  Your prescribing medical professional must adequately explain the increased risk of tardive dyskinesia posed by use of Reglan, particularly with extended use.  Since Reglan is only intended to be used for short-term relief of gastrointestinal problems when other treatments have failed, the risks associated with long term use are very serious.  Failure to properly monitor the duration of use, or the over prescribing of the medicine, may be negligent on the part of the physician.

What is Tardive Dyskinesia (TD)?
Tardive dyskinesia is a neurological syndrome that can be caused by the long-term use of neuroleptic drugs, including Reglan.  Different classes of neuroleptic drugs are prescribed for psychiatric disorders, but Reglan also has neuroleptic characteristics.
Tardive dyskinesia is most often characterized by repetitive, involuntary, purposeless movements.  Patients suffering from TD may exhibit involuntary facial gestures, such as grimacing, tongue protrusion, lip smacking, puckering and pursing, and rapid eye blinking. They may also suffer rapid and involuntary movements of the fingers, hands, arms, shoulders, legs, and trunk.   TD can even adversely affect the ability to breathe, swallow, walk, and talk.  
Tardive dyskinesia is a serious and potentially irreversible disorder.  It can be caused by Reglan and metoclopramide.

What is the connection between Reglan and Tardive Dyskinesia (TD)?
The FDA and the pharmaceutical manufacturers have long recognized that Reglan increases the risk of tardive dyskinesia.  The physicians and the patients using the drug are rarely made aware of the true nature of the risk, and the label for the drug does a poor job of explaining the dangers.  Many physicians are unaware that the drug is intended for short term use only, and continue to prescribe Reglan month after month.
Scientific and medical studies have suggested that as many as 1 in 4 patients who take Reglan for more than a year may develop symptoms of TD.  The conditions can occur in much shorter time periods as well.  Both the amount and the duration of the prescription appear to increase the risk of developing TD.
Likewise, studies have shown that the risk of developing TD is greater for children (especially infants) than for adults taking Reglan.  While TD can afflict anyone taking Reglan, children are apparently much more susceptible to the effects of Reglan.
Often the diagnosis of TD is a difficult one to make.  Reglan actually conceals the very symptoms it is causing, which makes it a difficult diagnosis to make.  For this reason, symptoms of TD will often surface only after the drug is discontinued.  As a result, the true extent of the injury is often greater than anticipated, because Reglan is continuing to cause a greater injury, while hiding the symptoms.

How is Tardive Dyskinesia treated?
Unfortunately, there is no known treatment for tardive dyskinesia.  In some cases, the syndrome may resolve or the symptoms may be reduced weeks or even months after a patient stops taking Reglan.   For some patients, however,  the damage is irreversible.

What can you do?
Contact Class Action Lawyer Network for a Reglan Tardive Dyskenesia form Reglanlawyer

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