Litigation

Reglan Gets A Blackbox Warning

By Angel L. Reyes, III

On February 26, 2009, the FDA required the manufacturers of metoclopramide-containing drugs such as Reglan to include a black-boxed warning (the strongest warning available) to their drug labels about the risk of the long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. Manufacturers will be required to include a medication guide with their products that discusses this risk.

According to the FDA, "Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped."

Reglan (generic name metoclopramide) is designed to be used only on a short-term basis to treat heartburn caused by gastroesophageal reflux, and prescribed to patients for whom other treatments have not worked. It is also used to treat slow gastric emptying in diabetics, a condition called diabetic gastroparesis which causes nausea, vomiting, heartburn and loss of appetite. Additionally, it may be used for treatment of other gastrointestinal conditions. Metoclopramide works by speeding up the movement of the stomach muscles, increasing the rate at which the stomach empties into the intestines. It is recommended that treatment not exceed three months.

Metoclopramide is available in tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection, and over two million Americans use these products.

"The FDA wants patients and health care professionals to know about this risk so they can make informed decisions about treatment," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk." Patients who have the highest risk include the elderly, especially older women, who have been taking Reglan over a long period of time.

©2009 Angel Reyes
www.ReyesLaw.com

Full post as published by Angel Reyes Blog on April 14, 2009 (boomark / email).