FDA requires boxed warning, risk mitigation strategy for Metoclopramide-containing drugs

WASHINGTON, Feb. 26 (Chinese media) -- The U.S. Food and Drug Administration (FDA)

announced Thursday that manufacturers of metoclopramide, a drug used to treat

gastrointestinal disorders, 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, which

may include involuntary and repetitive movements of the body, even after the

drugs are no longer taken.

Manufacturers were also 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 FDA said in a statement.

"The FDA wants patients and health care professionals to know about this

risk so they can make informed decisions about treatment," said Janet Woodcock,

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."

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. These symptoms are rarely reversible and there is no known

treatment. However, in some patients, symptoms may lessen or resolve after

metoclopramide treatment is stopped.

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

used as a short-term treatment of gastroesophageal reflux disease in patients

who have not responded to other therapies, and to treat diabetic gastroparesis

(slowed emptying of the stomach's contents into the intestines). It is

recommended that treatment not exceed three months.

Metoclopramide 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 2 million Americans use these

products.

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.