FDA requires black box warning-Reglan may cause permanent injury!

April 14, 2009 (NewYorkInjuryNews.com - Injury News)

New York, NY (NewYorkInjuryNews.com)–The U.S. Food and Drug Administration (FDA) www.fda.gov announced drug makers are now required to place a black box warning on all metoclopramide containing drugs like Reglan. Federal regulators must warn patients, healthcare professionals and medication consumers about the risk of serious injury in long-term or high-dose use of all metoclopramide containing drugs.

Metoclopramide has been linked to tardive dyskinesia a rarely curable condition which causes constant 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. Tardive dyskinesia is a chronic medical condition patients continue to suffer even after discontinuation of the harmful medication. These symptoms are rarely reversible and there is no known treatment. Reglan and other metoclopramide containing drugs are used to treat gastroesophageal reflux disease (GERD) and gastroparesis. Both medical conditions are chronic and incurable. The only successful treatment by doctors and nurses is symptom management. Recently published studies reveal metoclopramide is the most common cause of drug-induced movement disorders.

Metoclopramide containing medications are approved by the FDA for short term use no longer than 12 weeks maximum. Civil trial lawyers across the country specializing in product liability claims involving drug injury cases are in the process of investigating and filing claims against many metoclopramide drug companies. The product liability attorneys are alleging drug makers used deceptive marketing practices and misleading medication labeling for doctors to repeatedly prescribe the medications to patients suffering with the chronic gastrointestinal orders. This has caused many patients to take the medication for longer than the approved short term treatment, and at much higher doses, leading to cases of irreversible tardive dyskinesia.

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