FDA Requiring Black Box Warning Placed on Reglan

The U.S. Food and Drug Administration (FDA) has told the manufacturers of metoclopramide (brand name: Reglan), a drug used to treat gastrointestinal disorders, they must add a black box warning, the most serious type available, to their drug labels about the risk of its long-term or high-dose use. Long-term or high-doses of metoclopramide have been linked to tardive dyskinesia, even after the drugs are no longer taken.

Current labeling on the product mentions the risk of tardive dyskinesia with long-term treatment.

Those individuals at the greatest risk this condition include the elderly, especially older women, and people who have been on the drug for a long time.

The symptoms of Tardive dyskinesia include:

• Involuntary, repetitive movements of the extremities
• Lip smacking
• Tongue thrusting
• Grimacing
• Rapid eye movements or blinking
• Puckering or pursing of the lips
• Impaired movement of the fingers.

These symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after Reglan treatment is stopped.

Reglan works by speeding up the movement of the stomach muscles, which increases the rate at which the stomach empties. It has used as a short-term treatment of gastroesophageal reflux disease in patients who have not responded to other treatments. It has also been used to treat diabetic gastroparesis.

The FDA based its decision on published studies that suggest Reglan is the leading cause of pharmaceutical-related movement disorders.

FDA news article