U.S. Supreme Court Decision Favors Consumers

The U.S. Food & Drug Administration (FDA) recently gave a Black Box Warning the drug Reglan. This warning is needed because of the serious risks caused by Reglan.

Chronic use of Reglan causes a neurological disorder called tardive dyskinesia. This disorder is characterized by Parkinson-like symptoms. Patients suffer from repetitive and involuntary movements throughout their body. These symptoms are often irreversible. In addition, there is no treatment for tardive dyskinesia; people will suffer with these symptoms for the rest of the lives. In addition, Reglan can actually mask symptoms of tardive dyskinesia. The active drug in Reglan, metoclopramide, suppresses symptoms of tardive dyskinesia.

The FDA knows people are taking Reglan too long. Anything beyond three months is considered chronic use. The FDA knows these people are at risk for developing tardive dyskinesia. According to a study data from the FDA, over 20% of patients take Reglan for more than three months. In addition, two studies have shown that nearly 30% of patients who take Reglan for over a year develop tardive dyskinesia. These patients will constantly suffer from involuntary movements of their face, mouth, jaw, tongue, eyes, neck, shoulders, torso, larynx, diaphragm, arms, legs, feet, and hands. Clearly patients are not being made aware of the dangers of long term use. The FDA is not doing enough to warn patients about the risks of developing tardive dyskensia. In addition, the FDA has reports of people developing tardive dyskensia even though they took Reglan for less than three months.

Reglan is prescribed to treat gastroesophageal refleux, gastroesophageal relflux disease and diabetic gastroparesis. Older, female patients are at a high risk of developing tardive dyskinesia. However, children and infants have a greater risk of developing tardive dyskinesia than adults. Children and infants will also have to suffer from the symptoms of tardive dyskinesia for their entire lives.

The FDA is failing the public by not putting the Black Box Warning on Reglan sooner. The FDA also needs to make it clear that Reglan should only be used as a drug of last resort, meaning if all other treatments have failed. Because of the risk of developing an irreversible disorder, the FDA has to be better about warning the public of the dangers associated with Reglan. Patients should know the risk that taking a drug to treat acid reflux can lead to neurological disorders.