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Reglan It has recently been reported that the drug Reglan (also referred to as Metoclopramide) which is prescribed to treat gastrointestinal disorders (GERD) and nausea has been linked to the serious movement disorder Tardive Dyskinesia. Reglan, first approved in 1985, has been prescribed not only for acid reflux, but also for women who are pregnant and experiencing morning sickness, breastfeeding mothers, infants and children and for nausea associated with migraines. On January 26, 2009 the FDA issued an alert warning against chronic use of metoclopramide containing drugs and requiring a boxed warning. The Reglan side effect of Tardive Dyskinesia is a drug induced movement disorder, characterized by permanent symptoms that include random movements in the tongue, lips or jaw as well as facial grimacing, movements of arms, legs, fingers and toes along with swaying movements of the trunk or hip. After receiving an increasing number of reports regarding serious Reglan side effects, on February 26, 2009, the FDA mandated that Schwarz Pharma, a manufacturer of metoclopramide include "black box" warning labels of the Reglan® drug. Black box FDA warnings are the most serious type of FDA warning, as they indicate that a medication has the potential to cause life-threatening side effects. As part of the new printed warning, Schwarz Pharma must also include information regarding the complications associated with high Reglan dosage and use longer than 12 weeks. |
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