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 issued supplemental request letters to sponsors of all NSAIDs requesting that they make labeling changes to their products. These letters included 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. In December 2006 the FDA also proposed to amend labeling regulations to require new warnings regarding the potential for stomach bleeding in certain patients and to require that the term "NSAID" be prominently labeled on the medicine. Visit http://www.fda.gov/ for the most recent updates.
First published August 8, 2005
Last updated June 23, 2008
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