NSAID warnings from FDA

NEWS IN BRIEF — Posted July 4, 2005

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The Food and Drug Administration has asked for labeling changes on all nonsteroidal anti-inflammatory drugs, for both prescription and over-the-counter products.

The agency is asking that manufacturers of all OTC NSAIDs, such as ibuprofen, include more specific information about the potential for gastrointestinal bleeding and cardiovascular risks associated with the popular pain relievers. The FDA exempts aspirin from the new recommendations, noting that it has been clearly shown that aspirin reduces the risk of serious adverse cardiovascular events in certain patients.

The agency is also asking that black-box warnings be carried by all prescription NSAIDs, including Celebrex (celecoxib0, the only COX-2 selective NSAID still on the market. The warnings should highlight the potential for increased risk of cardiovascular events as well as gastrointestinal bleeding associated with their use.

Note: This item originally appeared at

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