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BMJ 2005;330:381 (19 February), doi:10.1136/bmj.330.7488.381-a
Scott Gottlieb
New York
| The first 150 words of the full text of this article appear below. |
Results from recent studies that raised concerns about the cardiovascular safety of cyclo-oxygenase-2 (COX 2) inhibitors have been made available early, in advance of hearings on the drug class by the US Food and Drug Administration.
All the studies have been published online in the New England Journal of Medicine (http://nejm.org), and the journal lifted its normal embargo date for the studies because of what it described as the "possible public health implications."
The results come immediately before a three-day hearing looking into the benefits and risks of COX 2 inhibitors that is being held by the US Food and Drug Administration's advisory committee, starting on 16 February. Among other things, the advisory committee is expected to evaluate recent data that suggest that, in addition to rofecoxib (Vioxx), other COX 2 inhibitors may be associated with an increased risk of cardiovascular events and to consider changes to the
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