Celecoxib still on the market: but for whose benefit?

(1) The cardiovascular risks associated with Cox-2 inhibitor therapy were confirmed in early 2005, and measures restricting the use of these drugs were taken in several countries. Yet celecoxib remains on the market. (2) Comparative trials versus other NSAIDs failed to show that celecoxib was any more effective for pain relief. And, following damning revelations that the CLASS study results had been manipulated, it became clear that celecoxib had no tangible advantage in terms of serious gastrointestinal complications. (3) An increase in Cox-2 inhibitor prescriptions, primarily based on their reputation for better tolerability, led to an increase in the absolute number of cases of gastrointestinal haemorrhage. (4) A trial focusing on the prevention of colorectal polyps showed that cardiovascular events occurred two to three times more frequently with celecoxib than with placebo. Another trial showed no significant difference. (5) In a trial involving patients with Alzheimer's disease, overall mortality was higher with celecoxib than in the placebo group. The difference was similar to that observed in placebo-controlled trials of rofecoxib in Alzheimer's disease. (6) The celecoxib affair once again highlights certain failings of the American and European regulatory agencies: celecoxib is still on the market, exposing patients to risks associated with its use without providing any therapeutic advantage.