Chronic use of Reglan Linked to Tardive Dyskinesia (TD)

Reglan is a widely used drug in patients with gastroesophageal reflux disease. Patients with gastroesophageal reflux (acid reflux) who have not responded to other therapies are often placed on Reglan. It is also used to treat diabetic gastroparesis (slowed emptying of the stomach's contents into the intestines). Reglan (Metoclopramide) works by speeding up the movement of the stomach muscles, thus increasing the rate at which the stomach empties into the intestines. It is recommended that treatment not exceed three months. Reglan (Metoclopramide) is available Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection.

Reglan Warning about Extended Usage

Recently published analyses suggest that metoclopramide is the most common cause of drug-induced movement disorders. Another analysis of study data by the FDA showed that about 20 percent of patients in that study who used metoclopramide took it for longer than three months. The FDA has also become aware of continued spontaneous reports of tardive dyskinesia in patients who used metoclopramide, the majority of whom had taken the drug for more than three months

FDA Reglan Warning

In 2009, the FDA announced that manufacturers of metoclopramide must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia. Manufacturers will be required to implement a risk evaluation and mitigation strategy, or REMS, to ensure patients are provided with a medication guide that discusses this risk. The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk.(See: FDA Black Box Warning for Reglan)

Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment. The development of this condition is directly related to the length of time a patient is taking metoclopramide and the number of doses taken. Those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time.

Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. Tardive Dyskinesia symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.