The U.S. Food and Drug Administration recently warned individuals taking the prescription gastrointestinal medication Reglan its side effects can be farther-reaching than what the manufacturers’ warnings imply.
Officials report an estimated 2 million Americans take medications containing metoclopramide for heartburn, Gastroesophageal reflux disease (GERD) and other gastrointestinal acid-related conditions.
According to a Feb. 26 FDA warning letter, long-term use of metoclopramide – the active ingredient in Reglan – has been linked to a condition called tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken.
This development prompted the FDA to mandate the drug’s manufacturers place a “black box warning” – the agency’s strongest warning – on the drug’s packaging. Metoclopramide can be found in Reglan tablets, oral disintegrating pills, metoclopramide oral solution and Reglan injections.
“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.”
Previous 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.
“Recently published analyses suggest that metoclopramide is the most common cause of drug-induced movement disorders,” the FDA warning letter reads. “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.”
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