Safety Alerts & Recalls

What does this mean?

Metoclopramide HCl is widely used for treating stomach and intestinal symptoms on a short-term basis. If you have been on Metoclopramide HCl for longer than 12 weeks, this safety alert highlights the importance of talking to your doctor and reviewing the benefits and risks of continuing treatment.

If you experience any signs of tardive dyskinesia, such as uncontrollable, repetitive movements of the arms and legs, uncontrollable movements of the face (such as lip smacking, sticking out of the tongue, rapid eye movements or blinking, puckering and pursing of the lips), or loss of the ability to move the fingers, please contact your doctor immediately.

Boxed Warning Added to Metoclopramide Labeling

The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide (also sold as the brand name Reglan) must add a boxed warning to the drug label about the risk of its long-term or high-dose use. Metoclopramide HCl is FDA approved for short-term use, up to 12 weeks, for stomach and intestinal symptoms of gastroesophageal reflux and symptoms of diabetes-associated delayed gastric emptying, such as nausea, vomiting, heartburn, persistent fullness after meals and loss of appetite.

Long-term use of Metoclopramide HCl has been linked to a rare but serious condition called tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drug is no longer taken. There is no known treatment for tardive dyskinesia and in some patients, the symptoms do not go away even when the drug is stopped. 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.

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Source: FDA
Publication Date: 2009-02-26
Last Updated: 2009-12-05

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