FDA Requires Changes to NSAID Labeling
CONSUMER HEALTH INTERACTIVE
FDA Requires Changes to NSAID LabelingOn April 28, 2009, the United States Food and Drug Administration (FDA) directed all manufacturers of over-the counter non-steroidal anti-inflammatory drugs (NSAIDs) to revise the labels for their products to ensure that they warn of the risk of stomach bleeding and that the term NSAID is prominently displayed on the container and the box. The new labels must be in place within a year of the ruling. This new rule comes four years after the FDA asked the manufacturer of Celebrex® (celecoxib), as well as all manufacturers of prescription and over-the-counter NSAIDs to voluntarily revise their labels to provide more specific information about the potential risk of cardiovascular (CV) events and gastrointestinal (GI) bleeding risks of their individual products and remind patients of the limited dose and duration of treatment of these products in accordance with the package instructions. Visit http://www.fda.gov/ for the most recent updates.
References
FDA. Questions and answers on final rule for labeling changes to over-the-counter pain relievers. May 2009. http://www.fda.gov/Drugs/NewsEvents/ucm144068.htm
Last updated July 31, 2009
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