Personal Injury Law

Reglan Gets a Blackbox Warning: Tardive Dyskinesia

What is Reglan? Reglan is used for the short-term treatment of heartburn in patients who have already tried other medications but had no relief of symptoms. The way that Reglan works is that it increases the muscle contractions in the upper digestive tract, which in turn speeds up the rate at which the stomach empties into the intestines. People that suffer from diabetes sometimes suffer from a slow gastric emptying, which can cause nausea, vomiting, heartburn, loss of appetite, and a feeling of fullness after meals, so they take Reglan as well.

In February of 2009, the FDA issued a warning about Reglan:

Agency warns against chronic use of these products to treat gastrointestinal disorders

The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its 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 implement a risk evaluation and mitigation strategy, or REMS, to ensure patients are provided with a medication guide that discusses this risk.

Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment. The development of this condition is directly related to the length of time a patient is taking metoclopramide and the number of doses taken. Those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time.

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.

Full post as published by A Georgia Lawyer on March 09, 2009 (boomark / email).