FDA Orders Black Box Warning for Reglan

In late February 2009, the U.S. Food & Drug Administration (FDA) ordered a Black Box Warning for drugs containing the active ingredient metoclopramide. Reglan is a brand name for a drug containing metoclopramide. Over two million people in the U.S. use this medication. The Black Box warning is the most serious warning the FDA gives.

Reglan is designed to treat acid reflux disease, heartburn, gastroesophageal reflux disorder and symptoms of diabetic gastroparesis. Reglan works by increasing the contractions of both the stomach and small intestine. This helps with the passage of foods and it speeds up the rate that the stomach empties into the intestines. There are several different forms of Reglan, including tablets, oral disintegrating tablets and injections. All three types now have the Black Box Warning.

Reglan is only recommended for short-term use. Patients should only take Reglan for 1-3 months. Long-term use of Reglan can lead to very serious side effects. Reglan has been shown to cause mild to severe depression in patients. In addition, Reglan can also cause Parkinson-like symptoms, such as tremor, rigidity and slow movements. The most severe side effect is tardive dyskinesia. Tardive dyskinesia is a neurological disorder, which causes involuntary and repetitive movements. Patients suffer from jerky movements in the jaw, mouth, tongue, face, arms, and legs.

The involuntary movements have decreased or stopped in a few patients after they stopped taking Reglan. Unfortunately for most patients, tardive dyskinesia is irreversible and they will continue to suffer from this disorder. There is not any known treatment for tardive dyskinesia. Most people will suffer from this disorder for the rest of their lives. The people most at risk for developing tardive dyskinesia are older, female patients. Risk of developing tardive dyskinesia is also linked to the dosage and length of time patients took Reglan. Other side effects of Reglan include intense restlessness, anxiety, agitation, foot-tapping, pacing, the inability to sit still, jitteriness and insomnia.

Because of the risk of developing tardive dyskinesia, the FDA ordered a Black Box Warning for the Reglan label. In addition, Reglan is required to provide a Medication Guide to patients before they take the drug.

If you believe that you or a loved one has suffered as a result of taking Reglan, you may want to speak with an attorney regarding a potential claim.

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Daniel D. Sewell, Angela B. Kodsi, Michael P. Caligiuri, and Dilip V. Jeste (1992). Metoclopramide and Tardive Dyskinesia. BIOL PSYCHIATRY 1994;36:63&632

Christopher Kenney, MD, Christine Hunter, RN, Anthony Davidson, BS,
and Joseph Jankovic, MD. Metoclopramide, an Increasingly Recognized
Cause of Tardive Dyskinesia. Journal of Clinical Pharmacology, 2008;48:379-384