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All About Metoclopramide Drugs

IMPORTANT FACTS ABOUT HOW REGLAN WORKS, AND THE DANGERS IT POSES TO UNSUSPECTING USERS

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  • Reglan is the brand name for metoclopramide, what is called a “prokinetic” drug that acts on gastrointestinal tract muscles, including those of the lower esophageal sphincter, the stomach, and the small intestine. It is used primarily by patients with gastroesophageal reflux disease (GERD) and is recommended to be used on a short-term basis of from four to twelve weeks, after other therapies have failed.
  • Normally, the lower esophageal sphincter – a kind of gateway between the stomach and the esophagus – prevents backup of stomach acid into the esophagus. In people with GERD, however, the sphincter is weakened and cannot do its job – allowing stomach acid into the esophagus and resulting in heartburn and damage to the esophagus.
  • Reglan and metoclopramide strengthen the muscle of the lower esophageal sphincter, which restores the sphincter to its normal function and decreases stomach acid and reflux. In addition, the drug stimulates stomach muscles to speed up the emptying of liquids and solids into the intestines.
  • Reglan is also used by patients with diabetic gastroparesis, where damage to the stomach nerves interferes with muscle function and delays emptying of the stomach. This condition can produce nausea, vomiting, stomach distention, and heartburn in people who suffer from diabetes. Reglan provides relief by helping the stomach empty more quickly, by reducing the reflux of stomach acid into the esophagus, and by interacting with dopamine receptors to alleviate nausea.
  • Metoclopramide comes in tablet, syrup and syringe (for injection) form, marketed under brand names that include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. The common dosage for patients with GERD is 10 to 15 milligrams four times a day, taken half an hour before each meal.
  • Reglan manufacturers describe their product as well-tolerated in low doses for brief periods of time – generally, three months. In fact, the FDA has never approved Reglan for long-term use (more than 12 weeks).
  • Neurological side effects have been documented as early as 1995 for patients who took the drug at higher dosages or for longer periods of time.  A December 1995 article in the Journal of the American Medical Association notes findings of Harvard researchers that within 90 days of a new prescription for Reglan, people taking the drug were exhibiting symptoms that were misdiagnosed as Parkinson’s disease.
  • After 1995, reports of Parkinson’s-like movement disorder symptoms linked to Reglan increased, until – nearly 14 years later – the Food and Drug Administration required Reglan and metoclopramide manufacturers to add a “black box” warning to their labels about the risk of tardive dyskinesia associated with long-term use of the drugs. Tardive dyskinesia mimics Parkinson’s disease with involuntary muscle movements, facial grimacing, and dystonic reactions (abnormalities of movement and muscle tone).
  • According to the FDA, development of tardive dyskinesia is directly related to the length of time a patient is taking Reglan, the strength of the dosage, and the number of doses taken. Recent studies indicate that metoclopramide is the most common cause of this debilitating movement disorder.
  • In addition to a more aggressive warning label, the FDA has required Reglan manufacturers to implement a risk evaluation and mitigation strategy – that is, to find out more and provide patients with a Medication Guide that discusses the risks. Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, says, “The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk.”
  • The FDA’s action and consequent patient access to information and warnings come too late for some of the two million Americans who use Reglan and other metoclopramide products. The symptoms of tardive dyskinesia are rarely reversible, and there is no treatment available.