Reglan® is a drug prescribed to treat a variety of symptoms, including heartburn, nausea, vomiting, and loss of appetite in some patients. Reglan’s chemical name is metoclopramide.
Reglan Linked to Severe Neurological Disorder
Reglan use has been linked to the development of a severe neurological disorder known as tardive dyskinesia (tahr-div dis-ki-nee-zhuh). According to the National Institute of Neurological Disorders and Stroke, tardive dyskinesia is characterized by:
- rapid eye blinking
- repetitive and involuntary movements of the arms, legs, fingers, or toes
- smacking, puckering, and pursing of the lips
- sticking the tongue in and out (tongue protrusion)
- swaying movements of the trunk or hips
- uncontrolled grimacing
Tardive dyskinesia is often extremely embarrassing for the affected person, as the related movements are uncontrollable and unintentional.
The warning label of the drug cautions, “Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with metoclopramide. There is no known treatment for established cases of tardive dyskinesia.”
Black Box Warning Update
The Food and Drug Administration (FDA) announced in February 2009 that Reglan manufacturers must add a black box warning—the strongest warning possible—to the class of the drug’s label regarding the risk of its long-term or high-dose use. Chronic use of the drug has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drug is no longer taken, according to the FDA.
The black box warning states: “Treatment with metoclopramide [Reglan] can cause tardive dyskinesia (TD), a potentially irreversible and disfiguring disorder characterized by involuntary movements of the face, tongue, or extremities. Although the risk of TD with metoclopramide has not been extensively studied, one published study reported a TD prevalence of 20% among patients treated for at least 12 weeks. 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 TD.”
Reglan comes in the following forms:
- Metoclopramide oral solution
- Reglan injection
- Reglan oral disintegrating tablets
- Reglan tablets
More than 2 million Americans use these products, according to the FDA.
If you or someone you care about has taken Reglan and been diagnosed with tardive dyskinesia, someone at our law firm would like to speak with you. We may be able to help you and your loved ones win compensation for medical bills, lost wages, and the pain and suffering endured while affected by tardive dyskinesia. We want to help.
Sources:
- The Food and Drug Administration Web site (www.fda.gov)
- The Mayo Clinic Web site (www.mayoclinic.com)
- National Institute of Neurological Disorders and Stroke Web site (www.ninds.nih.gov)
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