PDA

View Full Version : FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide-Containing


News Reader
02-26-2009, 05:05 PM
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.

More... (http://www.fda.gov/bbs/topics/NEWS/2009/NEW01963.html)