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Reglan warnings have increased and become more severe ever since this medication was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults for whom other therapies have not sufficiently improved their:

• diabetic gastroparesis/diabetic gastric stasis, or
• symptomatic gastroesophageal reflux

Black Box Reglan Warning

The FDA recently reviewed several studies and concluded that Reglan and other metoclopramide-based medications are "the most frequent causes of drug-induced movement disorders." Thus, an FDA advisory was issued in early 2009 to provide a more severe "Black Box" warning to physicians and patients regarding Reglan; that is, a warning stating that:

The chronic or long-term use of the Reglan drug (and other metoclopramide drugs) has been linked to tardive dyskinesia (TD), a movement disorder characterized by involuntary, repetitive movements of the body, even after the drugs are no longer taken.

Tardive Dyskinesia Symptoms: Rarely Reversible

A significant number of individuals who were treated with Reglan (whether in tablet, syrup, or injection form) have developed TD, much to their dismay. Although the FDA's Reglan warning notes that in some cases the symptoms of TD may become less severe after stopping Reglan treatment, the symptoms of TD are rarely reversible, and there is no known treatment for TD.

Additional Reglan Warnings

Two other warnings have been made more obvious on the Reglan packaging:

• Reglan is recommended for adults only.
• Reglan treatment should not go any longer than 12 weeks (three months).

The "Usual" Reglan Warnings

Reglan was introduced to the U.S. market with a significant number of warnings and precautions on its labeling and Prescribing Information — much like any other drug. The "usual" Reglan warnings include descriptions of the links between Reglan treatment and:

• depression, including suicidal thoughts and suicide
• extrapyramidal symptoms (e.g., facial grimacing, rhythmic protrusion of the tongue, involuntary movements of the limbs, dystonic reactions resembling tetanus)
• Parkinsonian-like symptoms
• neuroleptic malignant syndrome (NMS, a rare and life-threatening neurological disorder)

Learn More about Reglan Warnings

For more information about the many side effects of Reglan and other metoclopramide drugs, contact our Reglan lawyer today. If you have already been treated with Reglan and have been injured by the medication, we will connect you with an experienced attorney for defective drugs who will evaluate your case and fight to protect your legal rights.