In February 2009, the U.S. Food and Drug Administration (FDA) issued a mandate that required a black box warning for the branded drug Reglan. This type of warning represents the FDA’s highest level of concern surrounding targeted medications. It is typically ordered after medical testing reveals that a prescribed drug carries a high likelihood of severe side effects.

In the case of Reglan, and all drugs containing the generic metoclopramide, the black box warning raises the public’s awareness regarding potential risks. Below, I’ll explain why the drug was targeted by the FDA as well as what the placement of the black box warning implies. I’ll also describe the symptoms of tardive dyskinesia, the main condition highlighted on the new warning.

FDA Tardive Dyskinesia Video

Why The FDA Black Box Warning Was Ordered

Reglan is a common treatment path prescribed for gastrointestinal issues such as gastroesophageal reflux disease (GERD). It is also used by nursing mothers to increase milk production, though its use in that context is normally limited to the first two weeks. By contrast, patients who use drugs containing metoclopramide in order to treat GERD-related symptoms will often take the medication for several months.

Risk of Tardive Dyskinesia

Studies have shown that there is a marked increase in the likelihood of developing a condition called tardive dyskinesia after three months of continuous use. This risk also exists for patients using Reglan in high doses, even if their use is limited to less than three months.

The FDA, after confirming the risk, ordered the black box warning for Reglan as well as all prescription drugs containing metoclopramide. It’s worth noting that the package labeling for these products had already highlighted the risk of developing tardive dyskinesia with prolonged use. However, the black box warning raises the public’s awareness by surrounding the text with a black border. Furthermore, it lends the authority of the FDA behind the warning.

Symptoms Of Tardive Dyskinesia

Tardive dyskinesia is a devastating neurological disorder. It manifests as involuntary movements in the patient’s facial area, though it can also affect his or her extremities. Symptoms can include such unnatural movements as lip smacking, tongue protrusion, and uncontrollable lip puckering. Grimacing and rapid blinking of the eyes are also common.

One of the reasons tardive dyskinesia is so injurious is that there seems to be no cure once the condition develops. While there are treatment measures that can reduce or partially suppress the symptoms, patients are usually forced to live with the disorder throughout their lives.

It was for this reason the FDA saw fit to order the black box warning on all drugs that contain metoclopramide, including the branded Reglan. Unfortunately, while the recent mandate is necessary and helpful, it has come far too late for many people. If you are suffering from symptoms related to tardive dyskinesia and believe it to be a result of taking Reglan, consider contacting an experienced attorney to discuss your options.

We represent all clients suffering side effects from Reglan side effects on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Reglan attorney will contact you to answer any of your questions.