FDA Requires Boxed Warning for Metoclopramide Products

The FDA is requiring manufacturers of metoclopramide products to add a boxed warning to their product labels about the risk of long-term or high-dose use of the drugs, which are used to treat gastrointestinal disorders.

FDA officials said in a Feb. 26 news release that chronic use of metoclopramide has been linked to tardive dyskinesia, which is characterized by involuntary, repetitive movements of the extremities or facial features or impaired movement of the fingers.

"These symptoms are rarely reversible, and there is no known treatment," the agency said. "However, in some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped."

In addition to the boxed warning, manufacturers will be required to implement a risk evaluation and mitigation strategy to ensure patients are provided with a medication guide that discusses this risk.

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

Metoclopramide is indicated for short-term treatment of gastroesophageal reflux disease in patients who have not responded to other therapies. The drug also is used to treat diabetic gastroparesis.

The FDA has recommended that metoclopramide treatment not exceed three months, and product labeling already warns of the risk of tardive dyskinesia with chronic treatment. Development of the condition is directly related to the duration of treatment and the total cumulative dose, FDA officials said.

However, an analysis of study data by the agency showed that 20 percent of patients used metoclopramide for longer than three months.

In addition to patients who have been on the drug for a long time, those at greatest risk for tardive dyskinesia include the elderly, especially older women.

Produced in several formulations, metoclopramide is marketed as Reglan and is used by more than 2 million Americans, according to the FDA. Recently published analyses have suggested that metoclopramide is the most common cause of drug-induced movement disorders, the agency said.

Consumers and health care professionals are encouraged to report adverse drug events to the FDA's MedWatch program online or by calling (800) FDA-1088.