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U.S. Department of Health and Human Services

Safety

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Public Health Advisory: FDA Recommendations Concerning the Use of NSAIDs

Audience: All healthcare professionals and consumers 

The FDA issued a Public Health Advisory summarizing the agency's recent recommendations concerning the use of non-steroidal anti-inflammatory drug products (NSAIDs), including those known as COX-2 selective agents. This advisory was issued because of recently released data from controlled clinical trials showing that the COX-2 selective agents (Vioxx, Celebrex, and Bextra) may be associated with an increased risk of serious cardiovascular events (heart attack and stroke) and after release of preliminary results from a long-term clinical trial which suggested that long-term use of a non-selective NSAID, naproxen (sold as Aleve, Naprosyn and other trade name and generic products), may be associated with an increased cardiovascular risk compared to placebo. The public health advisory is an interim measure, pending further review by FDA of data that continue to be collected. 

[December 23, 2004 - Public Health Advisory - FDA]