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Reglan was FDA approved in the early 1980s for short-term (between 4 and 12 weeks) treatment of common gastrointestinal disorders such as gastroesophageal reflux disease (GERD), persistent heartburn, nausea, vomiting, and a feeling of stomach fullness. There are currently several generic Reglan (metoclopramide) products available on the market, each are made by different companies including Major Pharmaceuticals, Mutual Pharmaceuticals Company, Inc., Pliva, Inc., and Teva Pharmaceuticals, USA.
Metoclopramide is commonly prescribed for longer than 12 weeks, which is against FDA recommendations, and is directly linked to a neurological syndrome called tardive dyskinesia. Tardive means “delayed” and dyskinesia means “abnormal movement.” Tardive Dyskinesia can mimic disorders such as Parkinson's Disease, Tourette's Syndrome, Huntington's Chorea, tics, cerebral palsy, stroke and hyperactivity. Tardive Dyskinesia is often irreversible and may become permanent. Symptoms of tardive dyskinesia include involuntary movements, grimacing, lip movement and puckering, and sticking out the tongue and, in some cases, the arms and legs may twitch.
Reglan has now been assigned a "Black Box" warning from the FDA. This is the strongest warning level issued by the FDA and cautions the user that the medication may pose very serious risks to their health.
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WARNING
TARDIVE DYSKINESIA Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose.
Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.
Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.
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Cases have been filed against the manufactures of Reglan and the generic version- metoclopramide. If you have been taking Reglan and have experienced signs of tardive dyskinesia, contact Kristine Kraft.
Toll Free: 1-800-USE-LAWS (873-5297)
Tel: (314) 621-6115
Email Kristine Kraft:
kkraft@uselaws.com
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