Metoclopramide drugs to carry 'black box' warning: FDA

Washington, February 28: With recent evidence showing high association between metoclopramide-containing heartburn drugs and a risk of tardive dyskinesia, a drug-induced movement disorder, the U.S. Food and Drug administration on Friday ordered the black-box warning, the strongest alert possible, for the same.

The drug, Metoclopramide, used to treat gastrointestinal disorders, primarily heartburn, is marketed as Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution and Reglan Injection. An estimated 2 million Americans use the drug.

Potent in expediting the movement of the stomach muscles, Metoclopramide increases the rate at which the stomach empties into the intestines. The drug also finds its use in treating short-term gastroesophageal reflux disease and diabetic gastroparesis (condition that typically slows the emptying of the stomach’s contents into the intestines).

Recent trails post strong results charging metoclopramide-containing drugs as the most common cause of drug-induced movement disorders, FDA asserted. Moreover, FDA has also become aware of continued spontaneous reports of tardive dyskinesia in patients using metoclopramide, FDA officials added.

However, manufacturers maintain that the movement disorder to such extent is possible only if either the drug is taken in high doses, or over a long period of time. While the labeling specifies that it should not be taken longer than three months, study data by the FDA showed that about 20 percent of patients in that study used metoclopramide beyond the stipulated time.

As of now, the updated labels will carry a ‘black box warning’ detailing the risk of tardive dyskinesia, a medical condition characterized by involuntary and repetitive movements of the body, like grimacing, tongue protuberance, rapid eye movements, frequent blinking, puckering, lip smacking, pursing of the lips or impaired finger movement.

In addition, FDA also requires that such drugs should include a Risk Evaluation and Mitigation Strategy (REMS) which provides comprehensive details of dangers of high-doses and prolonged usage.

"The FDA wants patients and healthcare professionals to know about this risk so they can make informed decisions about treatment" said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk."

Black box warning, FDA’s sternest warning, implicates that the drug carries a significant risk of serious or even life-threatening adverse effects. Depending upon the seriousness of the adverse effects, the warning is either encrypted on the labeling of the prescription drug or in literature describing it.