Stomach reflux drug warning: long-term use can lead to movement disorder
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The FDA has ordered new warnings and stepped-up protections for the roughly 2 million Americans who take a class of drugs called metoclopramide, a treatment for intestinal disorders,including gastro-esophageal reflex disorder (or GERD). Patients who for long periods take medicines containing metoclopramide -- including those marketed as Reglan, Octamide and Maxolon -- are at high risk of developing a frightening movement disorder that in most cases is irreversible, the FDA has announced.
Metoclopramide has been on the U.S. market since 1985, and as many as 1 in 5 patients take medicines containing the drug for more than three months. But FDA says it has gathered evidence that long-term use of the drug is the single greatest drug-related cause of tardive dyskinesia, a movement disorder in which the afflicted person exhibits bizarre involuntary motor activity, including lip-smacking and puckering, eye-blinking and rapid eye movements, tongue protrusion, impaired movement of the fingers and jerking of extremities.
The elderly, especially older women, appear to be at greatest risk of developing this reaction to the medicine, says FDA. Metoclopramide is used to treat GERD that has not responded to other drugs, and is prescribed often to diabetic patients who suffer gastroparesis, or slowed emptying of the stomach’s contents into the intestines. Some cancer patients undergoing chemotherapy take the drug to combat nausea.
Tardive dyskinesia, which has also been associated with many drugs used to treat schizophrenia and bipolar disorder (listed here), is rarely reversible once it becomes evident.
Though companies making drugs that contain metoclopramide have been required to warn patients of this danger on their labels, the FDA’s action, announced Thursday, will require them to take stronger measures to ensure that patients know of this potential side effect. ‘The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk,’ says Dr. Karen Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
-- Melissa Healy
