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Reglan:
Side Effects And Problems Of Reglan

Reglan Drug:
Reglan - FDA Issues A Black Box Warning

Reglan Lawsuits:
Reglan Lawsuits And Injury Claims

FDA Takes Action Against Makers of Reglan – Adds ‘Black Box Warning’

On February 26, 2009, the U.S. Food and Drug Administration (FDA) announced that Baxter Healthcare Corporation, manufacturer of Reglan, must add a ‘black box warning’ to its drug, which is currently approved for the short-term use of severe nausea, vomiting and symptoms of GERD (gastroesophogeal reflux disease). Although Reglan’s current product labels already warn both the doctor and patient of dangerous side effects that can occur when taking metoclopramide-containing drugs, the addition of the ‘black box warning’ sends a more emphatic warning of possible extremely deleterious effects.

Serious Side Effects from Taking Reglan

The FDA approved Reglan, a dopamine receptor antagonist that possess central antiemetic and peripheral gastrointestinal motility effects, in 1985, for short-term use by patients suffering from severe nausea or vomiting when all other treatment methods have been attempted and have failed. When Reglan/metoclopramide is used for longer or at a higher dosage than approved, dangerous side effects such as tardive dyskinesia, dystonia, raised prolactin levels, epilepsy, depression, hypertension, persistent vomiting, Parkinson’s disease, renal insufficiency or lethargy, fatigue and drowsiness may occur.

Tardive dyskinesia, the most prevalent and perhaps most devastating side effect, is a syndrome characterized by involuntary and repetitive movements of the extremities and face and may include rapid eye movements and blinking, puckering and pursing of the lips, grimacing, lip smacking, tongue protrusion and impaired movement of the fingers. These symptoms are often irreversible although, in some patients, symptoms may lessen or even disappear after metoclopamide is stopped. These socially-unacceptable movements have forced many victims to become homebound for fear of being mocked in public. In patients who have taken Reglan for longer than 12 weeks, about 20% developed some form of this syndrome. Approximately one-third of patients have taken Reglan for more than one year for a variety of reasons. The elderly population, especially women, is at an increased risk for developing this devastating syndrome. There is no known treatment of tardive dyskinesia.

Dystonia, another destructive side effect of Reglan, is a neurological movement disorder in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures. Due to raised Prolactin levels, this drug should be used with caution in patients with previously diagnosed breast cancers. Depression is another extremely common and pervasive side-effect from taking Reglan. Metoclopramide is counterindicated during the first trimester of pregnancy and should only be used in lactating patients in extreme cases.

How Reglan Works in the Human Body

Reglan is a pro-motility medication that works by speeding up the movement of the gastrointestinal tract, including the stomach, esophagus, small intestine and/or colon, thereby increasing the rate that the stomach empties into the intestines. It works by strengthening the lower esophagus sphincter muscles. A weak lower esophagus sphincter allows reflux of stomach acid into the esophagus, which may cause heart burn and acid damage to the esophagus (peptic esophagitis). Metoclopramide may also help relieve GERD by speeding up the emptying of the stomach, which also reduces reflux.

It is normally used for the short-term treatment of gastroesophogeal reflux disease in patients who have not responded to other therapies, and to treat diabetic gastroparesis (slowed emptying of the stomach’s contents into the intestines). It is recommended that treatment not exceed three months. Metroclopramide, which is used by over two million Americans, is used to treat serious gastrointestinal problems, often associated with cancer chemotherapy treatments, migraine headaches and other causes of severe and chronic of nausea and vomiting. The Reglan drug interaction can be dangerous with certain other types of medications. Consult your doctor to avoid serious complications.

If you or someone you love has taken Reglan and contracted any of these devastating symptoms, fill out the form on this page today. We are here to see that justice is done!