Reglan FDA Black Box Warning

Drugs containing metoclopramide (the generic version of Reglan) have been prescribed for years as treatment for several conditions, including gastroesophageal reflux disease (GERD) and diabetic gastroparesis. The drugs trigger two physiological responses. First, they cause muscular contractions within the upper gastrointestinal tract. This helps the stomach contents empty into the intestines more quickly. Second, they help the esophageal sphincter remain closed, thereby preventing the patient's stomach contents from moving back into the esophagus.

On February 26th, 2009, the U.S. Food and Drug Administration (FDA) issued a black box warning on all metoclopramide-containing drugs. Below, I'll explain the specifics of this warning and the new responsibilities of Reglan manufacturers. I'll also describe the involuntary movement disorder tardive dyskinesia and how the FDA hopes to protect patients in the future.

Black Box Warning Covers All Metoclopramide Products

The FDA has mandated that their boxed warning be placed on the labels of all formulations of metoclopramide. That includes all forms of Reglan (i.e. oral solutions, injections, and tablets). The reason the FDA issued their mandate is due to the drug being associated with tardive dyskinesia, a lifelong, incurable disorder. Because over two million people currently take metoclopramide products, there is significant public exposure to tardive dyskinesia and other incapacitating side effects.

Under the black box warning, Reglan manufacturers are now required to highlight text that warns patients about the risk of tardive dyskinesia with chronic use of the drug. In addition, the FDA has mandated that makers of metoclopramide products initiate a risk evaluation and mitigation strategy (REMS). The purpose of the REMS is to further ensure patients are informed about the risks.

What Is Tardive Dyskinesia?

The boxed warning was finally drafted and approved by the FDA due to the link between drugs containing metoclopramide and the development of tardive dyskinesia. People who suffer from this disorder lose control of the muscles within their extremities, lips, eyes, and tongue. Involuntary lip smacking or pursing, repetitive tongue protrusions, and quick blinking are common. So too, are persistent muscle spasms or muscular rigidity.

Unfortunately, these side effects are often incurable. Once tardive dyskinesia is diagnosed, treatment is prescribed to reduce the severity of the symptoms rather than eliminate the disorder.

Protecting Patients And Mitigating Risk

The risk evaluation and mitigation strategy mandated as part of the FDA's black box warning seeks to protect patients by informing them of the risks of chronic Reglan use. Manufacturers are required to provide a medication guide that explains the link between metoclopramide products and tardive dyskinesia when use of the drug exceeds twelve weeks. By requiring this guide, the government hopes to reduce the public's exposure to the risks associated with taking these products.

Is It Time To Seek Legal Representation?

Reglan has been prescribed for decades to treat GERD, nausea and other conditions. While the FDA's boxed warning is a welcome move that promises to better inform patients of the risk, it does little to help those who are already suffering from the side effects. If you or someone you know has become a victim of tardive dyskinesia as the result of using Reglan products, now is the time to contact a lawyer to explore your legal rights.

About the Author:

Steve Fields is author of this article on Reglan Lawsuit. Find more information about Reglan Side Effects here.