Reglan is a prescription drug that is used to treat severe heartburn and gastroesophageal reflux disease in adults and children. In February 2009, the Federal Drug Administration placed a "black box" warning in package inserts of Reglan due to its adverse side effects. The warning states that patients who take Reglan long term may be at risk for an involuntary movement disorder called Tardive Dyskinesia.

How Reglan Works

Brand name Reglan tablets, manufactured by Alaven Pharmaceutical, and their generic counter-parts both work to enable the esophageal sphincter muscle to narrow and the pyloric sphincter muscle to relax. This allows food and drink to move through the stomach without refluxing back up into the esophagus. Reglan has been approved by the FDA for short term use, short term being described as "four to 12 weeks". Taken as directed by the FDA Reglan is safe and effective in combatting severe heartburn and gastroesophageal reflux disease. The serious side effects are seen when patients rely upon Reglan long term or beyond what has been approved by the FDA. Serious side effects are also seen in patients who are taking a much higher dose than what is advised or are not being monitored while taking the drug.

Reglan Side Effects

As with all prescription medications, Reglan has a comprehensive list of side effects. Most are not serious, some can be. The most common side effects of Reglan include fatigue, restlessness, erectile dysfunction, loss of bladder control, and vision changes. Some of the more serious yet not as common side effects include seizures, depression, Parkinsonian-like symptoms, and Tardive Dyskinesia.

Tardive Dyskenesia

Tardive Dyskinesia is a serious neurological disorder that causes random, involuntary, and often times repetitive movements of the face and body. Facial movements include repetitive eye blinking, lip smacking, and jaw and tongue movements. The jaw may move up and down as though chewing on gum and the tongue may thrust out of the mouth in a twisting manner. Involuntary movement of the fingers, hands, toes, feet, arms, legs, shoulders, and trunk can also take place. Patients suffering from Tardive Dyskinesia may also display complications when walking, talking, breathing, and swallowing.

Currently there is no treatment or cure for Tardive Dyskinesia. In some patients the disorder can be reversed, in others suffering may be lifelong.

Legal Implications

Recent legal action surrounding the prescription drug Reglan has occurred, as lawsuits are taking place across the U.S. against both the brand name Reglan and its generic alternatives. Because the drug companies did not make it well known that very serious side effects such as Tardive Dyskinesia can occur with long term use, many patients who have taken Reglan long term are suffering needlessly. Cases are being looked at and evaluated on an individual basis. At this point it is unlikely that a class action lawsuit will occur.

Reglan should only be taken for up to 12 weeks. Persons who are on Reglan should be closely monitored by their doctor. The patient's doctor should be notified immediately if any side effects become present. Raglan should be discontinued immediately if any symptoms of Tardive Dyskinesia appear.