South Carolina Reglan Attorney
Reglan® (metoclopramide) was recently directed by the FDA to add a black box warning--the strongest possible--for the side-effect of tardive dyskinesia. A severe neurologic disorder, tardive dyskinesia is characterized by:
- rapid blinking of eyes
- repetitive, involuntary movements of extremities
- tongue protrusion
- smacking lips, puckering or pursing lips
- gyrating or swaying hips
- uncontrollable smiling or grimacing
Tardive dyskinesia is often extremely embarrassing for the affected person, as the related movements are uncontrollable and unintentional. Reglan® is prescribed for a variety of symptoms including heartburn, vomiting, and loss of appetite.
The warning label on Reglan® states, "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."
FDA Warning Updated
The FDA announced in Feb 09 that manufacturers of Reglan are required to add a “black box warning”—the strongest possible warning—to the drug’s label regarding long-term or high-dose usage.
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 these forms:
- Metoclopramide oral solution
- Reglan injection
- Reglan oral distegrating tablets
- Reglan tablets
According to the FDA, more than 2 million Americans use Reglan products.
If you or someone you care about has taken Reglan and have been diagnosed with tardive dyskinesia, our Dan Pruitt would like to speak with you. Our firm may be able to help you and your loved ones win compensation for medical bills, lost wages, and pain and suffering associated with tardive dyskinesia.
More about Reglan:
The Food and Drug Administration (www.fda.gov), Mayo Clinic Web (www.mayoclinic.com), National Institute of Neurological Disorders and Stroke Web (www.ninds.nih.gov). Reglan is a registered trademark of Schwarz Pharma, Inc.