Reglan Tardive Dyskinesia Warning Added to Black Box by FDA

The FDA is now requiring that tablets, syrups and injections containing metoclopramide, commonly known as Reglan, must carry a new black box warning on their label about the risk of developing tardive dyskinesia when the medications are used at high doses or for a long time.

Metoclopramide, which is sold as Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution and Reglan Injection, is used for treatment of gastrointestinal disorders.

The drug speeds up the rate at which the stomach empties into the intestines by increasing the movement of the stomach muscles. However, side effects of Reglan and metoclopramide could increase the risk of developing involuntary and repetitive movements of the body even after the drug is stopped, which is known as tardive dyskinesia.

Symptoms of tardive dyskinesia can appear in the body extremeties, particularly the lower face. It is associated with involuntary movements like grimacing, repetitive chewing, lip smacking, pursing and puckering of the lips, tongue protrusion, rapid eye movements, blinking and impaired finger movements.

Metoclopramide-containing drugs like Reglan are often used as a short-term treatment of gastroesophageal reflux disease in situations where other treatments have not been effective. It is also commonly used to treat diabetic gastroparesis, which occurs when the rate at which the stomach empties into the intestines is slowed.

The Reglan tardive dyskinesia side effects are associated with the chronic or long-term use of the drug. It is not recommended that the treatment be used for more than three months and the prior warning label already contained information about the risk of tardive dyskinesia with chronic use. However, the risk information will be moved to a more prominent location on the label, contained in a “black box,” which is the strongest warning that can be placed on a prescription medication.

“The FDA wants patients and health care professionals to know about this risk so they can make informed decisions about treatment,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk.”

About two million people in America use Metoclopramide-containing drugs like Reglan, which are manufactured by Baxter International, Inc. and other generic drug companies.

The symptoms of tardive dyskinesia can rarely be reversed and there is no known treatment that is consistently successful.

Those that face the greatest risk of the Reglan causing tardive dyskinesia include the elderly, women and those that are on the drug for extended periods of time.