What are the grounds for Reglan/metoclopramide litigation?
Reglan, or its generic counterpart, metoclopramide, is given to persons suffering from a variety of reflux-related ailments, including gastroesophageal reflux disease (GERD), diabetic gastroparesis, diabetic gastric stasis, nausea and vomiting. Although Reglan can be a safe and effective treatment for these diseases – it is only safe under very limited circumstances: 1) when safer, more traditional therapies fail, and 2) when used for a very short time (under 12 weeks). Unfortunately, these limited circumstances are not well-publicized by the drug makers and many doctors and patients are unaware of the limits, or the devastating side effects that can occur if used long-term. The most serious side effect is Tardive Dyskinesia, a potentially irreversible neurological disorder that causes involuntary, dyskinetic movements.
What has been done so far with regard to Reglan tardive dyskinesia litigation?
Numerous suits are pending around the country against the makers of Reglan. Because each case is unique, each case is being handled on an individual basis and it is unlikely that there will be any class-action litigation for persons who have suffered personal injuries from this drug.
What options do I have if I’ve been affected by Reglan?
You may qualify for an individual suit against the makers of this drug for your specific damages.
What are the treatments for the disorders caused by Reglan?
Check with your doctor first, but unfortunately, there are no effective treatments for Tardive Dyskinesia at this time. New options are being studied and because different treatments may work for different people, it is important to discuss the possibilities with your doctor.
What are the dangers of Reglan/metoclopramide?
Tardive Dyskinesia is the most serious and potentially irreversible side effect of long-term use of Reglan. This disorder manifests itself in repeated, involuntary movements of the limbs, facial grimacing, torticollis, blinking, rhythmic protrusion of the tongue and similar movements. It often becomes more serious the longer a user remains on the drug. Unfortunately, the drug itself can “mask” or hide these movements/symptoms while the user is on the drug, and it may not be until her or she is taken off the drug that the full effects are seen.
Other side effects of this drug include:
Depression, which can range from mild to severe and can include suicidal ideation and suicide;
Extrapyramidal symptoms, including acute dystonic reactions;
Parkinsonian-like symptoms, including tremor and rigidity.
Other, less serious side effects include:
Restlessness, including anxiety, agitation or jitteriness
Drowsiness
Fatigue
Insomnia or sleeplessness
Headache
Confusion
Dizziness
Which products contain Reglan and metoclopramide?
Reglan is the brand-name of the product and is still sold under this name. Additionally, there is a generic form of Reglan called metoclopramide or metoclopramide hydrochloride. It is sold in tablet, syrup and injectable forms.
Are there any safer alternatives to Reglan and metoclopramide?
Check with your doctor first. You may be able to use another reflux medication such as Prilosec or Nexium. These have been effective for some patients, although they may not be right for everyone. It is important to discuss this with your physician.
What could have been done to avoid the current Reglan/metoclopramide Tardive Dyskinesia situation?
Several things:
Adequate and more accurate testing prior to FDA approval could have revealed the long-term risks, like Tardive Dyskinesia, that became known after the product was already on the market;
More extensive research and monitoring could have been done after the approval and release of the drug to reveal the long-term dangers of the drug;
Information provided to doctors and patients could have included clearer, more accurate information about the true effectiveness and dangers of the drug;
A concerted effort could be made to switch patients to safer alternatives or if Reglan use is indicated, repeated efforts must be made to ensure no use exceeds 12 weeks in duration.
What are Reglan and metoclopramide and what are they used for?
Reglan/metoclopramide is used to treat reflux-related ailments, including gastroesophageal reflux disease (GERD), diabetic gastroparesis, diabetic gastric stasis, nausea and vomiting. They are identical drugs; one being the brand-name (Reglan) and the other being generic (metoclopramide). They work by stimulating movement of the esophagus and the upper gastrointestinal tract. They belong to a class of drugs called dopamine antagonists, which are often used to treat psychosis. Despite the very different uses for the drugs, long-term use of most dopamine antagonists can lead to irreversible involuntary movement disorders such as Tardive Dyskinesia.
