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FDA Requires Boxed Warning and Risk Mitigation Strategy for Reglan

By Jessica Smagacz

Yesterday FDA announced that manufacturers of the drug metoclopramide, most commonly found in Reglan, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use.

Metoclopramide is a drug used in the treatment of gastrointestinal disorders. It has been linked to tardive dyskinesia, 'which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken.'

Patients need to know about this risk in order to make an informed decision about the treatment they will use. This is why FDA is implementing this requirement. FDA is also requiring the manufacturers to implement a risk evaluation and mitigation strategy (REMS) in order to ensure patients are provided with the information to guide them and discuss the risks.

Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research said, 'The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk.'

The current labeling only warns of the risk of tardive dyskinesia with chronic metoclopramide treatment.

The greatest risk of taking this medication is on the elderly, especially older women and people who have been on the drug for a long time.

FDA explains tardive dyskinesia as this:

'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.'

Metoclopramide speeds up the movement of the stomach muscles and increases the rate at which the stomach empties into the intestines. It's usually used in short-term treatment and recommended to not exceed three months.

The drug is available in a variety of formulations including tablets, injections, and syrups. Names include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection.

Over two million Americans use this product. This product has been suggested as the most common cause of drug-induced movement disorders.

FDA also studies showed that about 20 percent of patients who used the drug took it for longer than three months.

Originally posted at InjuryBoard by Jessica Smagacz

Full post as published by Atlanta Personal Injury Lawyer on March 03, 2009 (boomark / email).