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Reglan Lawsuits – Old Post Discussing an Old Mass Tort

Reglan is a pharmaceutical drug used to combat heartburn and slow gastric emptying in diabetes patients. The question is whether tardive dyskinesia (also known as TD), a neurological disorder with symptoms including repeated involuntary movements, is connected to Reglan use.

Below is a question and answer for potential Reglan plaintiffs:

What is Reglan?

Reglan is a “prokinetic” drug that helps control gastroesophageal reflux disease by blocking dopamine receptors in the brain and throughout the body. It enhances movement or contractions of the esophagus, stomach, and intestines. Dopamine is a chemical in the brain that sends signals between nerves. Doctors and pharmaceutical companies have been experimenting with dopamine in psychotropic drugs for years with mixed results.

What Are the Reglan Lawsuits About?

pills-300x218Certainly, it is well known that Reglan causes side effects. Most commonly it can cause a feeling of “strangeness” or difficulty concentrating. This is a typically reversible condition. Our Reglan injury lawyers are investigating Reglan’s connection to tardive dyskinesia, in which the tongue or face moves involuntarily. Afflicted patients may experience many uncontrolled and involuntary movements, including:

· Grimacing
· Protrusion of the tongue
· Lip smacking
· Rapid eye blinking
· Swaying of the hip and upper body
· Movement of the extremities

Regrettably, these side effects of tardive dyskinesia can be permanent. There is currently no treatment for tardive dyskinesia caused by Reglan. In some cases, the symptoms may lessen or stop once the Reglan use is discontinued. The gist of the Reglan lawsuits is that the risks of tardive dyskinesia were minimized in the Reglan label and other literature put out by the manufacturer. Reglan patients were not given all the information about the risks associated with Reglan.

Why Does Dopamine Cause Tardive Dyskinesia?

No one knows for sure why dopamine causes tardive dyskinesia. But the conventional wisdom is that by blocking dopamine receptors, Reglan can affect the extrapyramidal system the controls the signals between nerves. The inability of dopamine to produce its normal effects apparently causes tardive dyskinesia and its associated side effects because the extrapyramidal system needs dopamine to function.

Should Reglan Be Recalled?

Should Reglan have had a more meaningful label regarding tardive dyskinesia and involuntary movements? The FDA  requires a black box warning for Reglan.

Moreover, the manufacturers of Reglan and other generic metoclopramide-containing drugs should stop pushing it for mild heartburn. Heartburn is seldom (if ever) severe enough to risk the permanent injuries associated with tardive dyskinesia. Plaintiffs’ Reglan lawyers certainly believe that the label minimized that risk for patients by implying that there was minimal danger in developing tardive dyskinesia from Reglan. Specifically, the original Reglan label said it “may produce extrapyramidal reactions, although these are comparatively rare.” Other sections of the label likewise indicated that tardive dyskinesia is a low risk. Here, the victim and the FDA agree. The FDA now requires the makers of Reglan to place a black box warning on their label, the most stringent act the FDA can take in requiring a warning.

What About Patients with Gastroparesis?

I don’t know. The Gastroparesis issue is more complicated. Ordinarily, the stomach churns food and slowly delivers digested food into the patients’ intestinal tract. In people with Gastroparesis, the stomach does not work normally and food eaten will remain in the stomach sometimes for hours, distending it and causing severe symptoms for some sufferers. Patients with severe Gastroparesis can have serious health consequences that are difficult to live with. If there was a complete Reglan recall, these patients would not have many options because the only oral drug currently approved by the FDA for Gastroparesis is Reglan (or generic metoclopramide). It is only slightly effective for many patients, but for some patients, it is very effective. So, in severe cases, Reglan may be the best solution, providing patients are adequately warned about the side effects.

What Did Wyeth Know About Reglan?

In 1992, an article was published by Dr. Ronald B. Stewart on the use of Reglan by 4,515 elderly patients at the Florida Geriatric Research Program. Of the patients who reported using metoclopramide, 32% had used it for more than one year. The plaintiffs’ experts have testified in these cases that Wyeth has estimated extended use of Reglan to be over 80%. This led Dr. Steward to conclude that long-term treatment with Reglan is “quite common” and that other prescription drugs were effective and safer for treating GERD:

The routine use of metoclopramide (Reglan) for gastroesophageal reflux should be questioned considering the availability of safer, more effective drugs such as histamine-receptor blocking agents cimetidine and ranitidine, and omeprazole. The long-term efficacy and symptomatic benefit of metoclopramide have not been documented.

The point is that Wyeth apparently knew that Reglan patients were using the drug longer than the 12 weeks that is indicated and that tardive dyskinesia occurs more often than “rarely,” as Wyeth wants us to believe.

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