Hemorrhage rofecoxib

Two recently published articles have helped to clarify this point a systematic review of randomized clinical trials on the upper gastrointestinal safety of celecoxib (90) and a population-based retrospective cohort comparison of the rate of upper gastrointestinal hemorrhages in over 40 000 NSAID-naive elderly users of non-selective NSAIDs, celecoxib, or rofecoxib with the rate in 100 000 patients who had not been exposed to NSAIDs (91). 

This study has provided further evidence that the risk of upper gastrointestinal hemorrhage with COX-2 inhibitors is significantly lower than with conventional NSAIDs, whether or not they are taken with misoprostol. The apparently greater risk of gastrointestinal hemorrhage with rofecoxib than with celecoxib needs... 

A 60-year-old man developed angioedema after taking two doses of rofecoxib 12.5 mg 18 and 12 hours before (133). Despite intensive treatment he developed pulmonary hemorrhagic edema and died a day later. He had fibrotic lung disease, which may have predisposed him to the lethal event. 

The final analysis of the Adenomatous Polyp Prevention on Vioxx (APPROVe) study (n = 2587 patients rofecoxib 25 mg, n = 1287 and placebo, n = 1300) included the combined incidence ofnon-fatal myocardial infarction, non-fatal stroke, and death from cardiovascular, hemorrhagic, and unknown causes (Antiplatelet Trialists Collaboration, APTC, combined end-point) and found that 59 individuals had an APTC combined end-point in the rofecoxib 25 mg group versus 34 in the placebo group (HR = 1.79 95% Cl = 1.17, 2.73) [13 ]. 

Observational studies In postmarketing surveillance of serious adverse events associated with the use of rofecoxib from 1999 to 2002 there were 31 024 reports of serious adverse events, and the drug was considered the primary suspect in 97.8% of reports [51 ]. There were 3915, 3677, 1653, 1917, and 233 reports of hemorrhage, edema, death, thrombosis, and embolism respectively. The authors argued that, in addition to the risk of myocardial infarction and stroke, rofecoxib use might be associated with an increased risk of hemorrhage. A limitation of this analysis was that the data may have contained multiple reports from the same individual. 

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