A popular drug often prescribed to treat stomach upset may cause serious side effects.
Reglan (known generically as metoclopramide) is often prescribed to treat a variety of stomach and esophageal problems, including nausea and vomiting (caused by chemotherapy or migraines), diabetic gastroparesis (slow emptying of the stomach into the intestines), hyperemesis gravidarum (severe morning sickness during pregnancy) and gastrointestinal reflux disease (in which stomach acid backs up into the esophagus).
Manufactured by Schwarz Pharma, Reglan was first approved by the FDA in 1985 for use in a range of gastrointestinal ailments. It is classified as a dopamine antagonist, a drug that blocks the reception of the neuro-chemical dopamine. Reglan has now been linked to a range of mild to serious side effects. In rare instances, Reglan side effects can be fatal.
One of the most disturbing side effects to which Reglan has been linked is a severe neurological condition called tardive dyskinesia. This disorder is characterized by involuntary, repetitive writhing movements of the extremities, fingers and toes; rapid eye blinking; swaying of the trunk or hips; facial grimacing; random tongue protrusion; and smacking, puckering, or pursing of the lips. Young children and the elderly are particularly susceptible to developing this disease.
Tardive dyskinesia is rarely reversible and there is no known treatment.
Recent studies suggest that metoclopramide drugs such as Reglan are the most common cause of drug-induced movement disorders like tardive dyskinesia.
It is estimated that more than two million people in the United States use products containing metoclopramide in its many available forms, such as tablets, syrups and injections. Some of the widely-used products containing metoclopramide are Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection.
On February 26, 2009, the Federal Food and Drug Administration issued a safety alert to the public in the strongest possible terms; the FDA mandated that Reglan drug labels display a "black box" warning to inform the public about serious Reglan side effects and the risk factors for these complications.
As part of the printed warning, Schwarz Pharma must also include information regarding the complications associated with high Reglan dosage and using Reglan for longer than 12 weeks at a time.
Black box warnings indicate that a medication has the potential to cause life-threatening complications.
Lawsuits concerning Reglan and tardive dyskinesia are emerging across the country. While rare, other serious side effects of Reglan have been noted in the suits, including hallucinations, jaundice, seizures, severe allergic reaction, tachycardia (arrhythmia and increased heart rate), and neuroleptic malignant syndrome, a life-threatening neurological condition marked by delirium, fever and muscle rigidity.