The FDA has recently required the manufacturers of the drug metoclopramide, more commonly know as Reglan, to place a black box warning on its label alerting consumers of the link between the drug and a condition called tardive dyskinesia. Tardive dyskinesia is characterized by involuntary and repetitive movements of the body. A black box warning is the strongest warning that the FDA can require.
Reglan is used to treat gastrointestinal disorders, such as heartburn caused by gastrophageal reflux, as well as diabetic gastroparesis. Metoclopramide increases muscle contractions in the upper digestive tract, which speeds up the rate at which the stomach empties into the intestines.
Tardive dyskinesia is a condition in which a person develops involuntary movements of their muscles which could include lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers. The symptoms are rarely reversible and there is no known treatment.
Those at increased risk for developing tardive dyskinesia are the elderly, especially older women, and people who have taken the drug for a long time. The FDA has advised physicians to avoid long term use of metoclopramide except in rare cases where the benefit outweighs the risks, and recommends treatment not exceed three months.
Metoclopramide is available in formulations including tablets, syrups and injections, under names including Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injections. According to the FDA, it is estimated that more than 2 million American use these products.
Consumers also are advised to report any adverse events associated with the use of Reglan or metoclopramide to the FDA’s MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.