Australia. A significant number of cases of GI adverse effects associated with rofecoxib and celecoxib have been reported to the Adverse Drug Reactions Advisory Committee (ADRAC), many involving elderly patients with known risk factors. However, 16 reports of celecoxib-associated peptic ulcer and 16 of celecoxib- and 5 of rofecoxib - associated GI haemorrhage occurred in patients aged less than 60 years with no stated risk factors. The Committee points out that ‘the serious events reported to ADRAC suggest that selective COX-2 inhibitors should be treated with similar caution to other NSAIDs’.
Australian Adverse Drug Reactions Bulletin 22: 15, No. 4, Aug 2003.