Mastodon FDA approves new warnings for celecoxib ~ Pallimed

Friday, November 11, 2005

FDA approves new warnings for celecoxib

Medscape is reporting that the FDA has approved new warnings about celecoxib today (article here--requires free Medscape membership--I can't currently find this news story anywhere else which is weird). This seems to be the meat of it:
"The FDA also warned that chronic use of celecoxib may be linked to an increased risk for serious and potentially fatal cardiovascular thrombotic events, MI, and stroke. As with other NSAIDs, these risks may increase in the presence of existing cardiovascular disease and/or related risk factors. The warning was based on results of the Prevention of Sporadic Colorectal Adenomas with Celecoxib trial in 1,356 patients, showing that use of 400 mg of celecoxib twice daily was linked to a 3.4-fold increase in the composite risk of cardiovascular death, MI, or stroke, relative to placebo (95% confidence interval [CI], 1.4 - 8.5). In patients receiving 200 mg of celecoxib twice daily, the relative risk was 2.4 (95% CI, 1.0 - 6.4)."

Update Nov 13, 2005: well the reason I couldn't find any other news stories on this is because the warnings came out in July, which I completely missed, and for some reason Medscape decided to write a news story about it on the 9th. I'm laughing at myself.

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