FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide-Containing Drugs

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide-Containing Drugs

FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide-Containing Drugs
Thu, 26 Feb 2009 15:55:00 -0600

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.

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