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Tardive Dyskinesia & Reglan
Reglan (Generic: Metoclopramide), manufactured by Baxter Healthcare, gained FDA approval in 2004. Reglan is prescribed to treat Gastroesophageal Reflux Disease, acid reflux disease and symptoms such as, nausea, vomiting and heart burn. The FDA approved Reglan to be used by patients for a term of 4-12 weeks. Continuous treatment beyond 12 weeks is not recommended, however 1/3 of patients are being prescribed to medication for 12 months or greater. The extended use of Reglan has led to the development of Tardive Dyskinesia in 27-29% of long term use patients.
Reglan/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). According to the FDA, 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 who had taken the drug for more than three months.
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. According to a February 26th, 2009 FDA warning letter, long-term use of metoclopramide – the active ingredient in Reglan – has been linked to tardive dyskinesia, even after the medication is 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. Previous product labeling warns of the risk of tardive dyskinesia with chronic Reglan treatment. The development of this condition is directly related to the length of time a patient is taking Reglan 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.
If you or a loved one took Reglan and have been diagnosed with Tardive Dyskinesia, please fill out the form or contact us directly at 800-923-6376.
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