FDA Warning Over Reglan: Users May Face Irreversible Muscle Disorder
If you use the prescription drug Reglan, take note: you may be at risk for an incurable muscle disorder that causes uncontrollable facial twitches.
The U.S. Food and Drug Administration (FDA) says extended use of Reglan, which is used to treat gastrointestinal diseases, may cause tardive dyskinesia -- a serious and often irreversible muscle condition.
Symptoms
People with tardive dyskinesia are afflicted with rapid muscle movements that are repetitive, involuntary and purposeless. The condition may affect facial muscles, resulting in grimacing, tongue protrusion, lip-smacking, puckering and pursing of the lips, and rapid eye-blinking.
Patients with tardive dyskinesia have difficulty not moving. Victims of tardive dyskinesia are often embarrassed by the symptoms of the disease and may withdraw socially, leading to depression.
Uses
Reglan has been prescribed to more than 2 million Americans for gastroesophageal reflux disease, diabetic gastroparesis and delayed gastric diseases. Metoclopramide medications speed up the movement of the stomach muscles, thus increasing the rate at which the stomach empties into the intestines, helping to relieve stomach distress.
Reglan is recommended for up to three months of use, but one in every five users takes it for longer periods because of the chronic nature of their conditions. The extended use puts patients at a higher risk of developing tardive dyskinesia.
FDA Warning
As a result of these serious side effects, the FDA has required the makers of Reglan, the brand name for metoclopramide, to make safety related changes to Reglan's packaging, including the addition of a boxed warning -- the strongest labeling requirement the FDA can order against a drug. The boxed warning includes the statement that “ chronic treatment with metoclopramide can cause tardive dyskinesia.”
Contact Us
If you have been affected by tardive dyskinesia due to the use of Reglan, you may be entitled to compensation for your injuries. Our qualified pharmaceutical lawyers can help you determine if you have a case.
Contact Gordon & Doner, P.A. by completing our online contact form or call us toll free at 1-800-659-1159.
