Reglan Linked to Severe Neurological Disorder

by fstrack | July 25th, 2009

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 dyskinesi is characterized by:

  • repetitive and involuntary movements of the arms, legs, fingers, or toes
  • uncontrolled grimacing
  • sticking the tongue in and out (tongue protrusion)
  • smacking, puckering, and pursing of the lips
  • rapid eye blinking
  • swaying movements of the trunk or hips

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.”

The U.S. Food and Drug Administration 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.”

If you or someone you care about has taken Reglan and been diagnosed with tardive dyskinesia, An attorney at Nurenberg Paris 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.

Reglan is a registered trademark of Schwarz Pharma, Inc., and is used here only to identify the product in question.