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FDA orders Reglan black box warning
The Food and Drug Administration has ordered the makers of Reglan and its generic equivalent, metoclopramide, to add “black-box” warnings to their labels due to an increased risk of an involuntary movement disorder known as tardive dyskinesia. About 20% of patients who took one of the two drugs for more than three months developed tardive dyskinesia.
The symptoms of tardive dyskinesia can be debilitating and are rarely reversible. Patients may experience repeated, involuntary movements of the face or extremities, or other symptoms. Studies have indicated that Reglan and its generic equivalent, metoclopramide, are the most frequent causes of drug-induced movement disorders.