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June 15, 2005
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA has requested that sponsors of all non-steroidal anti-inflammatory drugs (NSAID) make labeling changes to their products. FDA recommended proposed labeling for both the prescription and over-the-counter (OTC) NSAIDs and a medication guide for the entire class of prescription products. All sponsors of marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, have been asked to revise the labeling (package insert) for their products to include a boxed warning, highlighting the potential for increased risk of cardiovascular (CV) events and the well described, serious, potential life-threatening gastrointestinal (GI) bleeding associated with their use. FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern.
Read the complete MedWatch 2005 Safety summary, including a link to the updated Drug Information Page and Medication Guide, at:
http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#NSAID
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