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 Adverse Cases


Back Reported Adverse Drug Reaction Cases
Serious gastrointestinal effects with celecoxib and rofecoxib
ADRAC has received a significant number of reports of peptic ulcer (with and without perforation or haemorrhage) and of gastrointestinal (GI) haemorrhage with celecoxib (Celebrex) and rofecoxib (Vioxx).

Many of the patients with peptic ulcer had known risk factors: they were aged = 60 years (73% for celecoxib vs 97% for rofecoxib), they had a history of peptic ulcer (18% vs 0%) or they were taking other medication which increased their risk (45% vs 81%). However, 16 of those who developed peptic ulcer with celecoxib (none with rofecoxib) were aged < 60 years and had no stated risk factors. In five of these cases the ulcer was diagnosed within 4 weeks of initiation of celecoxib. In nine of the 16 cases, the diagnosis was confirmed by endoscopy, radiology, or during surgery.

Table: Reports of peptic ulcer or GI haemorrhage with celecoxib and rofecoxib

 

Celecoxib

Rofecoxib

PBS prescriptions
May 2000 to Dec 2002

9.3 million

4.3 million

Total reports

3315

637

Total peptic ulcers

101

31

     with risk factors

84

31

     without risk factors

16

-

Total GI haemorrhage

250

56

     with risk factors

234

51

     without risk factors

16

5

Of the reports of GI haemorrhagic events (in the absence of a diagnosis of peptic ulcer), 16 cases with celecoxib and five with rofecoxib involved patients aged < 60 years, with no stated history of GI ulcer and no concurrent use of another NSAID. Those reports mentioning alcohol as a possible factor were excluded. For these 21 cases, time to onset ranged from 1 day to 8 months (median 13 days). In four cases the reaction occurred after a single dose, and in one of these cases the patient's haematemesis recurred following a single dose a week later.

Initial results from clinical trials indicated a rate of upper GI ulceration with celecoxib or rofecoxib of around 2 per 100 patient-years during 6-9 months' treatment, significantly lower than with the nonselective NSAIDs.1,2 However, while a pivotal study suggested that there may be a long-term advantage of rofecoxib over the nonselective NSAIDs for upper GI ulceration,1 results after 12 months' usage of celecoxib indicated similar rates of ulcer complications to diclofenac and ibuprofen.3 The differences between celecoxib and rofecoxib apparent in the ADRAC data may reflect the differences seen in the clinical trials and/or they may relate to differences between the populations of users. Whatever the absolute rates of peptic ulcer may be with celecoxib and rofecoxib, the serious events reported to ADRAC suggest that selective COX-2 inhibitors should be treated with similar caution to other NSAIDs.

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