FDA Requests Changes to NSAID Labeling
CONSUMER HEALTH INTERACTIVE
FDA Requests Changes to NSAID LabelingOn April 7, 2005, the United States Food and Drug Administration (FDA) asked the manufacturer of Celebrex® (celecoxib), as well as all manufacturers of prescription and over-the-counter non-steroidal anti-inflammatory drugs (NSAIDs), to revise the labeling for their products. This request does not apply to aspirin. An update to this request was added on June 15, 2005. At this time, the FDA has issued supplemental request letters to sponsors of all NSAIDs requesting that they make labeling changes to their products. These letters include recommended proposed labeling for both the prescription and over-the-counter (OTC) NSAIDs and a medication guide for the entire class of prescription products. Manufacturers of non-prescription (OTC) NSAIDs are being asked to revise their labeling 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.
First published August 8, 2005
Last updated January 23, 2007
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