Reglan Lawsuit Information
Reglan (metoclopramide) is a medication that helps with the digestive process and reduces the symptoms of acid reflux and heartburn. It is used for short term relief by individuals who have not been helped by the usual over-the-counter remedies.
Reglan is also used to treat slow gastric emptying in people with diabetes. This condition (diabetic gastroparesis) can cause nausea, vomiting, heartburn, loss of appetite, and a feeling of fullness after meals. The drug induces contractions in the upper intestinal tract that under normal circumstances are part of the digestive process. Some diabetics have chronic problems with these contractions, which don’t occur as they should. The medication inhibits relaxation of the stomach and increases relaxation in the muscles of the upper intestine, thereby accelerating the digestive process.
In February of 2009 the FDA issued a Public Health Advisory that included notification of a change in the packaging information provided by the manufacturers of the medications. This new “black box” labeling warns of problems with long term use and recommends against prescribing for patients with a movement disorder (Parkinson’s), a seizure disorder or a history of depression.
Evidence suggests that Reglan can cause a condition known as tardive dyskinesia, with symptoms characterized by tics, involuntary hand and limb movement, facial grimacing and other uncontrollable physical movement. This condition appears to arise most often with patients that have been using the drug for an extended period. The drug was approved by the FDA in 2004 for short term use only (4 – 12 weeks).
Some patients have exhibited symptoms of neuroleptic malignant syndrome, a serious condition with symptoms that include high fever, sweating, unstable blood pressure, stupor, muscular rigidity and an autonomic instability in general. This condition is usually a near-term extreme reaction that can be life threatening.
Reglan remains on the market with its new packaging information despite the fact that the development of tardive dyskinesia in long term users may be a substantial segment of all long term users. One of the elements of the FDA warning requires that a risk-mitigation strategy be developed by manufacturers of all drugs containing metoclopramide, in order to ensure that all patients receiving these medications are aware of the dangers to people who use the drug over an extended period.