It won't be surprising for some HD families to read about the February 2009 FDA's black box label requirement for Metoclopramide [Reglan] drugs because of the potential of Tardive Dyskinesia in long term use. If you read the drug's info, three of the conditions listed for people who shouldn't take Reglan are those with a: history of depression, Parkinson's disease or a movement disorder and epilepsy or other seizure disorders. Yet this drug is prescribed by physicians for HD patients who experience stomach problems [GERD], projectile vomiting, the healing of esophageal ulcers, intractable hiccups, etc. Many HD patients who have been prescribed Reglan have experienced not only symptoms of NMS and/or TD but hallucinations, paranoia, suicidal thoughts, severe anger outbursts etc.. Because of this, every time I hear of someone being prescribed Reglan I send them to the information on the link below the news article. Metoclopramide brand names: Octamide, Maxolon, Metoclopramide Oral Solution, Reglan including Reglan Tablets, Reglan Oral Disintegrating Tablets, and Reglan Injection FDA Requires Boxed Warning For Metoclopramide Drugs - Thu Feb 26, 2009http://www.reuters.com/article/companyNews/idUSN2629346520090226 and others Excepts only: WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration said Thursday it was requiring manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, to add a boxed warning to their drug labels about the risk of developing a neurological disorder. 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. 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 said development of tardive dyskinsia "is directly related to the length of time a patient is taking metoclopramide and the number of doses taken." The FDA recommended that treatment not exceed three months because the risk of the movement disorder was "directly related to the length of time a patient is taking metoclopramide and the number of doses taken." "The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk," said Janet Woodcock, the director of FDA's Center for Drug Evaluation and Research.
Friday, February 27, 2009
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