Posted By Jim Vititoe on March 1, 2009
FOR IMMEDIATE RELEASE
Feb. 26, 2009
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888-INFO-FDA
Agency warns against chronic use of these products to treat gastrointestinal disorders
The U.S. Food and Drug Administration announced today 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 will be 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 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.”
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 two 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.
Consumers and health care professionals are encouraged to report adverse events to the FDA’s MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md. 20852-9787, or online at: www.fda.gov/medwatch/report.htm
For information about REMS see: Public Law 110-85
If you have been seriously injured by the above event, please visit the products liability lawyers at Masry & Vititoe for a case evaluation. Through experience and education, Masry and Vititoe is able to expertly evaluate medical injuries and pursue personal injury claims on behalf of the injured plaintiff.
Categories: FDA, Medical Warning
Tags: drug warning
About the author
Jim was born in Oklahoma City, Oklahoma on March 14, 1947. His father was in the military and his family moved to Germany when Jim was 5. In 1956, his family relocated back to the United States and lived in Georgia. In 1965, Jim graduated from Northside High School in Warner Robins, Georgia, where he was President of the Student Body, Honorary Mayor of the Town and selected as Most Versatile Student.
Jim attended the College of William & Mary in Williamsburg, Virginia and graduated with a degree in psychology in 1971. He moved to Hawaii to work for United Airlines and to enjoy his passion for worldwide travel. He also managed to attend the University of Hawaii for a few extra enrichment classes.
In 1973, Jim moved to Los Angeles to attend Southwestern University School of Law. He was on the Dean's List, President of the Student Bar Association, and was the recipient of the prestigious Frederick Graff Award for most outstanding student.
After graduation from Law School, Jim became an associate in the Law Offices of Edward L. Masry. Jim worked for several years as an associate attorney and in 1982 Jim became a partner. The Law Offices of Edward L. Masry was renamed The Law Offices of Masry & Vititoe. Jim married Karen Dutcher in 1984 and they have two children, Justin and Travis.
Over the past 20 plus years, Jim has specialized in civil tort litigation. He has handled thousands of wrongful death cases, work-related injuries, and personal injuries. Typical cases have included auto collisions, product liability, premises liability, medical malpractice, and environmental exposure. Recently, his focus and specialty has been brain injury cases including severe and mild traumatic brain injuries [MTBI].
Jim has received much recognition over his career. He has received the U.S. Congressional Award for Trial Lawyer of the Year in 1990, 1991 and 1992. Consumer Attorneys of California awarded him Trench Soldier of the Year in 1996; Presidential Recognition for Exceptional Contribution in 1996; Outstanding Consumer Advocate in 1997; and the President's Award of Merit in 2000. Trial Lawyers for Public Justice (TLPJ) awarded Jim the President's Award in July 2001 in recognition of his extraordinary work and success in building membership support.
Jim was appointed to the Board of Governors for the Consumer Attorney Association of Los Angeles in 1998. He was appointed to the Board of Governors for the American Trial Lawyers Association, Trial Lawyers for Public Justice, and Consumers Attorneys of California in 2001.
Jim was born in Oklahoma City, Oklahoma on March 14, 1947. His father was in the military and his family moved to Germany when Jim was 5. In 1956, his family relocated back to the United States and lived in Georgia. In 1965, Jim graduated from Northside High School in Warner Robins, Georgia, where he was President of the Student Body, Honorary Mayor of the Town and selected as Most Versatile Student.
Jim attended the College of William & Mary in Williamsburg, Virginia and graduated with a degree in psychology in 1971. He moved to Hawaii to work for United Airlines and to enjoy his passion for worldwide travel. He also managed to attend the University of Hawaii for a few extra enrichment classes.
In 1973, Jim moved to Los Angeles to attend Southwestern University School of Law. He was on the Dean's List, President of the Student Bar Association, and was the recipient of the prestigious Frederick Graff Award for most outstanding student.
After graduation from Law School, Jim became an associate in the Law Offices of Edward L. Masry. Jim worked for several years as an associate attorney and in 1982 Jim became a partner. The Law Offices of Edward L. Masry was renamed The Law Offices of Masry & Vititoe. Jim married Karen Dutcher in 1984 and they have two children, Justin and Travis.
Over the past 20 plus years, Jim has specialized in civil tort litigation. He has handled thousands of wrongful death cases, work-related injuries, and personal injuries. Typical cases have included auto collisions, product liability, premises liability, medical malpractice, and environmental exposure. Recently, his focus and specialty has been brain injury cases including severe and mild traumatic brain injuries [MTBI].
Jim has received much recognition over his career. He has received the U.S. Congressional Award for Trial Lawyer of the Year in 1990, 1991 and 1992. Consumer Attorneys of California awarded him Trench Soldier of the Year in 1996; Presidential Recognition for Exceptional Contribution in 1996; Outstanding Consumer Advocate in 1997; and the President's Award of Merit in 2000. Trial Lawyers for Public Justice (TLPJ) awarded Jim the President's Award in July 2001 in recognition of his extraordinary work and success in building membership support.
Jim was appointed to the Board of Governors for the Consumer Attorney Association of Los Angeles in 1998. He was appointed to the Board of Governors for the American Trial Lawyers Association, Trial Lawyers for Public Justice, and Consumers Attorneys of California in 2001.
Jim is currently a member of the American Trial Lawyers Association, American Bar Association, Trial Lawyers for Public Justice, Consumer Attorneys of California, Consumer Attorneys Association of Los Angeles, and the Los Angeles County Bar Association.
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