FDA Warns About Link Between Common Heartburn Drug and Severe Neurological Disorder

The Food and Drug Administration has issued a new warning about metoclopramide, the drug used to temporarily treat gastrointestinal disorders that has been linked to involuntary, repetitive body movements and other symptoms, which may last for years after stopping the drug.

About two million people in the United States take drugs containing metoclopramide in syrup, tablet, and injection forms, including popular brand names such as Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection.

Treatment for Stomach Ailments

Metoclopramide decreases gastrointestinal disorders by speeding up the movement of stomach muscles and increasing the rate at which the stomach empties food into the intestines. The drug is designed to be used as a short-term treatment of gastroesophageal reflux disease in patients who have not responded to other therapies. It also is commonly used to treat slowed emptying of the stomach’s contents into the intestines, a condition called diabetic gastroparesis.

Products containing metoclopramide have been linked to an increase in the risk of developing tardive dyskinesia, a neurological disorder characterized by involuntary movement of the hands, arms, and other extremities, lip smacking, grimacing, rapid eye movements and blinking, tongue protrusion, and impaired finger movement, according to the FDA.

Tardive dyskinesia is most common in the elderly, particularly older women, and increases with the length of time metoclopramide has been taken. In most cases, the symptoms of the disorder are irreversible and there is no known treatment, although some patients have seen improvement in their condition after stopping metoclopramide, officials said.

New Research Shows Link

Newly released data suggests that metoclopramide is the most common cause of drug-induced movement disorders. About 20 percent of patients in one study who used metoclopramide took it for longer than three months and tardive dyskinesia has been reported in patients who used metoclopramide, most of them having taken the drug for more than three months, the FDA said.

For this reason, taking metoclopramide for longer than three months is not recommended and the chronic use of the drug should be avoided in all but rare cases where the benefits are believed to outweigh the risk, according to the FDA.

FDA Strengthens Warnings

The FDA has ordered that companies making drugs containing metoclopramide add prominent “Black Box” warnings to the products’ packaging to further alert physicians and users about the increased risk of developing tardive dyskinesia from long-term use or high doses of the drug. The drugs already contain warnings on the packaging and accompanying printed materials.

Drug manufacturers will also be required to implement a risk evaluation and mitigation strategy to ensure patients are provided with a medication guide that discusses the heightened risk, the FDA said.

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