Celebrex Has No Safety Advantage Over NSAIDs, Panel Says
Celebrex’s manufacturer’s are not going to like this. The new selective COX-2 inhibitors where designed to be safer on the stomach (don’t forget that NSAIDs can also damage the liver, kidneys, GI tract other than the stomach, as well as the joints themselves…). But post-marketing studies do not support the advocacy of safer stomachs, primarily with concomitant use of aspirin. And remember, the population that is most likely to be continued users of “arthritis drugs” will also be more likely to be taking an aspirin a day for heart disease prevention.
(article) A postmarket study of celecoxib, conducted by the drug firm Pharmacia, failed to establish the drug’s safety superiority to nonsteroidal anti-inflammatory drugs (NSAIDs), an advisory panel to the US Food and Drug Administration (FDA) determined on Wednesday. The Arthritis Advisory Committee met here to discuss whether findings from Pharmacia’s extensive Celecoxib Long-term Arthritis Safety Study (CLASS) trial proved that celecoxib is safer than ibuprofen and diclofenac, and whether COX-2 inhibitors taken with aspirin may pose a health risk that warrants further study. The panel agreed that Pharmacia had not established a “clinically meaningful” safety advantage over NSAIDs and that data from the CLASS study would not support a superiority claim at present. According to the committee, the ability of the CLASS study to demonstrate a better safety profile was hindered by one compelling factor: concomitant aspirin use. Although the trial showed an overall twofold reduction in gastrointestinal complications in celecoxib-treated patients, that trend was reversed among subjects who took also low-dose aspirin. Among aspirin takers, celecoxib did not demonstrate safety superiority over ibuprofen or over pooled NSAIDS da….