Naproxen adverse events

Problems have also occurred in interpreting the results of VIGOR (33). There were significantly fewer upper gastrointestinal adverse events with rofecoxib compared with naproxen, but an unexpected substantial excess of serious cardiovascular events, making the overall safety of rofecoxib uncertain. When the... 

Nabumetone is a naproxen derivative, whose efficacy is related to its active metabolite, 6-methoxy-2-naphthyla-cetic acid. Not unexpectedly, a study in 2000 patients, mostly treated for more than 6 months, ehcited an adverse events pattern similar to the other derivatives of this class of NSAIDs (SEDA-13, 81). Adverse effects were reported in 18% of patients and 10% stopped taking the drug because of adverse reactions. Diarrhea was the most common problem (13%) followed by abdominal pain (9.9%), dyspepsia (9.3%), nausea (7.8%), and flatulence (4.7%). Ten ulcers were detected. Nervous system reactions, skin rashes, edema, unspecified eye disorders, and liver function test abnormahties aU occur (1). 

The safety profile of over-the-counter naproxen has been adequately evaluated, and the incidence of adverse events was similar to the incidence with placebo, ibuprofen, and paracetamol. There were no serious adverse reactions in these studies (SEDA-20, 93). 

Although opioid dose requirements are reduced with short-term use of NSAIDs including naproxen, it remains unclear whether reductions in dose are associated with a decrease in opioid-related adverse events such as nausea, vomiting, and constipation. Like other nonselective NSAIDs, naproxen is often withheld in the peri-operative period for fear of surgical site and GI bleeding. It should be appreciated that unlike aspirin, inhibition of platelet aggregation with naproxen is reversible, and temporally related to serum drug concentration. 

However, some non-selective NSAIDs other than naproxen may also increase cardiovascular risk. Coxibs cause more cardiovascular adverse events than naproxen but do not seem to increase cardiovascular risk compared with some other non-selective NSAIDs [5, 9 7- For example, data from the MEDAL study (n = 23 504 patients, see above) showed that the thrombotic cardiovascular risk hazard ratio of etoricoxib versus diclofenac was 0.96 (95% Cl = 0.81, 1.15), suggesting that etoricoxib was not more dangerous than diclofenac [bF]. 

Recent evidence has confirmed the lower risk of upper (but not lower) gastrointestinal adverse events with coxibs compared with traditional NSAIDs and also the increased cardiovascular risk with regular use of coxibs compared with placebo. However, the evidence now suggests that there may also be an increased cardiovascular risk for some (non-naproxen) non-selective NSAIDs. 

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