Feb. 27, 2009 -- The FDA has ordered a "black box" warning, the FDA's strongest warning, for drugs that contain metoclopramide, which is used to treat gastrointestinal disorders.
The boxed warning will highlight the risk of tardive dyskinesia, or involuntary and repetitive movements of the body, with long-term or high-dose use of metoclopramide, even after the drugs are no longer taken.
Drugs that contain metoclopramide include Reglan tablets, Reglan oral disintegrating tablets, metoclopramide oral solution, and Reglan injection. More than 2 million Americans use these products, according to the FDA.
Those drugs' labels already note the risk of tardive dyskinesia with chronic metoclopramide treatment. Now, that risk will be highlighted in the boxed warning.
Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering, pursing of the lips, or impaired movement of the fingers.
These symptoms are rarely reversible and there is no treatment. But in some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.
The development of tardive dyskinesia 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.
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% 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, most of whom had taken the drug for more than three months.
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.
The FDA encourages consumers to report adverse events to the FDA's MedWatch program. You can reach MedWatch by phone at 800-FDA-1088 and on the FDA's web site.