FAQ's: Reglan

What is Reglan?

What is tardive dyskinesia?

Who is most at risk?

What has the FDA said about Reglan?

What is Reglan?

Reglan® (metoclopramide, its generic form) is a prescription medication commonly used for the short-term treatment of heartburn and acid reflux in patients with gastroesophageal reflux disorder (GERD), a condition in which stomach contents backflow into the esophagus. Reglan works by increasing the contractions of the stomach and small intestine, helping with the passage of food. Reglan is also used to treat the symptoms of diabetic gastroparesis, a condition in which the stomach does not contract, which include vomiting, nausea, heartburn, feelings of indigestion, persistent fullness after meals, and appetite loss. Reglan is also given to prevent nausea and vomiting associated with chemotherapy, surgery, migraines and pregnancy. Reglan is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. More than two million Americans use these products.

Long-term use of Reglan has been linked to a number of serious movement disorders including tardive dyskinesia, a serious involuntary and repetitive movement disorder that is often irreversible.

What is tardive dyskinesia?

Tardive dyskinesia is a central nervous system disorder that is characterized by involuntary, repetitive movements of the extremities, lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, impaired movement of the fingers, shaking of hands or feet, abnormal head movements, uncontrolled bodily movements. Exposure to Reglan for longer than 12 weeks greatly increases the There is no cure or effective treatment for the condition. However, the symptoms may be reduced or eliminated if the patient stops taking Reglan.

Who is most at risk?

Those at greatest risk include infants, young children and the elderly, especially older women. Prolonged exposure to Reglan increases the risks of Tardive Dyskinesia. The FDA recommends that Reglan not be used for longer than 12 weeks given the increased probability of Tardive Dyskinesia.

What has the FDA said about Reglan?

In February 2009, the U.S. Food and Drug Administration issued a public warning about the long-term or high-dose use of Reglan due to concerns about patients developing Tardive Dyskinesia. The FDA required the makers of Reglan and other metoclopramide drugs to add a black box warning to the products' labeling about the risks of high-dose use or long-term use of the drugs. The FDA recommended that treatment with Reglan not exceed 12 weeks. This decision to issue a black box warning was made because recently published analyses suggest that Reglan or 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 Reglan took it for longer than 12 weeks. The FDA has also become aware of continued spontaneous reports of tardive dyskinesia in patients who used Reglan, the majority of whom had taken the drug for more than 12 weeks.

Read more about Reglan Injuries.

If you would like more information regarding Reglan lawsuits and Tardive Dyskinesia, please visit our new Reglan website, Reglan Justice