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FDA Black Box Warning Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose. Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment... |
FDA Black Box Warning Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose. Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia. |
Patients taking the heartburn drug metoclopramide (REGLAN) are advised that the Food and Drug Administration (FDA) has announced warnings about drug-induced involuntary movements caused by the drug.
According to the FDA’s February 2009 announcement, all products containing metoclopramide are required to display a black box warning (included above) in their professional product labels or package inserts warning about tardive dyskinesia, a sometimes irreversible movement disorder.
Tardive dyskinesia may include involuntary and repetitive movements of the body. Those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time. These involuntary movements may continue even after patients stop taking metoclopramide.
Metoclopramide is approved by the FDA for heartburn after eating and during the daytime (symptomatic gastroesophageal [GI] reflux) and for a GI condition in diabetics known as gastroparesis. The drug has not been shown to be safe and effective for children.
First approved in 1979, metoclopramide is one of the top-selling generic drugs in the U.S., with almost 6.5 million prescriptions dispensed in 2008. The drug is available in a variety of forms, including tablets, syrups and injections.
An analysis published in the March 2008 Journal of Clinical Pharmacology suggested that metoclopramide is the most common cause of drug-induced movement disorders, including tardive dyskinesia.
What You Can Do
We first warned about metoclopramide’s ability to cause tardive dyskinesia in the February 1996 Worst Pills, Best Pills News and, even earlier, in the first edition of our book, "Worst Pills, Best Pills" in 1988.
If you or a family member are taking metoclopramide and have developed uncontrollable movements, contact the prescribing physician immediately.
Pharmacists are now required to distribute an FDA-approved medication guide with each new and refill prescription for metoclopramide. You can also read an electronic version of the medication guide, available on the FDA’s Web site at: www.fda.gov/Drugs/DrugSafety/ucm085729.htm.
