Onsenal: marketing authorisation withdrawn in the European Union. Company failed to supply required data.

摘要

In late March 2011, European marketing authorisation for Onsenal0 (cele-coxib; Pfizer) was withdrawn at the company's request (1,2). Onsenaldeg had been marketed in France since late 2010. This nonsteroidal anti-inflammatory drug, a "selective" cox-2 inhibitor, was authorised in the European Union for "the reduction of the number of adeno-matous intestinal polyps in familial ade-nomatous polyposis", despite a negative harm-benefit balance (2,3).The efficacy of celecoxib in terms of colorectal cancer prevention has not been demonstrated, but its adverse effect profile is particularly unfavourable and includes haemorrhage and cardiovascular disorders (3). Marketing authorisation had been granted in 2003 under "exceptional circumstances" (a), with the company obligated to continue the assessment in order "to provide further data" (1,2).