"Black Box" Warnings Ordered for Metoclopramide Drugs

Some drugs used to treat gastrointestinal disorders will soon have a "black box" warning. A black box warning is the strongest warning that the FDA requires for drug labels. Metoclopramide is a drug that helps to treat gastrointestinal disorders such as gastroesophageal reflux disease and diabetic gastroparesis, by speeding up the movement of the stomach muscles to quicken the emptying of stomach contents into the intestines. Recently, the FDA ordered a black box warning for the labels of drugs containing metoclopramide, including Reglan pills and injections. Such drugs carry a risk of tardive dyskinesia or involuntary and repetitive movements of the body. The risk of tardive dyskinesia comes with long term or high dose use of metoclopramide. There is no treatment for tardive dyskinesia. According to recently published research, metoclopramide may be the most common cause of drug-induced movement disorders.