Severe Hepatotoxicity Associated With Bromfenac Sodium

Moses, Peter L.; Schroeder, Brad; Alkhatib, Ousama; Ferrentino, Nicholas; Suppan, Thomas; Lidofsky, Steven D.

doi:10.1111/j.1572-0241.1999.01093.x

Cited by 65 publications

(19 citation statements)

References 6 publications

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“…Data from rat models of hypertension suggest that celecoxib but not rofecoxib may be associated with improvements in endothelial function and reductions in oxidative stress, but this finding has not been reported in all studies. 5,6 There are other examples of specific agents in a medication class with distinct side effect risks, such as bromfenac, a nonspecific NSAID, with a higher than typical risk of hepatoxicity 20 and cerivastatin, a lipid-lowering agent that is associated with rhabdomyolysis at increased rates compared with other statins. 21 …”

Section: Discussionmentioning

confidence: 99%

Relationship Between COX-2 Specific Inhibitors and Hypertension

et al. 2004

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Abstract-There is controversy whether cyclooxygenase-2 (COX-2) specific inhibitors are associated with elevations in blood pressure requiring treatment in typical clinical practice. We examined the risk of new onset hypertension in a retrospective case-control study involving 17 844 subjects aged Ն65 years from 2 US states. Multivariable logistic models were examined to assess the relative risk of new onset hypertension requiring treatment in patients who used celecoxib or rofecoxib compared with patients taking either the other COX-2 specific inhibitor, a nonspecific NSAID, or no NSAID. During the 1999 to 2000 study period, 3915 patients were diagnosed and began treatment for hypertension; 4 controls were selected for every case. In no model was celecoxib significantly associated with the development of hypertension. Rofecoxib users were at a significantly increased relative risk of new onset hypertension compared with patients taking celecoxib (odds ratio [OR] 1.6; 95% confidence interval [CI], 1.2 to 2.1), taking a nonspecific NSAID (OR 1.4; 95% CI, 1.1 to 1.9), or taking no NSAID (OR 1.6; 95% CI, 1.3 to 2.0). There were no clear dosage or duration effects. In patients with a history of chronic renal disease, liver disease, or congestive heart failure, the relative risk of new onset hypertension was twice as high in those taking rofecoxib compared with celecoxib (OR 2.1; 95% CI, 1.0 to 4.3). In this retrospective case-control study of patients aged Ն65 years, rofecoxib use was associated with an increased relative risk of new onset hypertension; this was not seen in patients taking celecoxib.

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Section: Discussionmentioning

confidence: 99%

Relationship Between COX-2 Specific Inhibitors and Hypertension

et al. 2004

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“…Despite these efforts, the manufacturer and the FDA continued to receive reports of severe injuries, including reports of death or need for liver transplantation (Moses and Schroeder et al 1999;Hunter and Johnston et al 1999;Rabkin and Smith et al 1999;Fontana and McCashland et al 1999). Given the availability of other effective NSAIDs, bromfenac was withdrawn from the market in June 1998.…”

Section: Duract (Bromfenac)mentioning

confidence: 99%

ACG Clinical Guideline: The Diagnosis and Management of Idiosyncratic Drug-Induced Liver Injury

Chalasani

Hayashi

Bonkovsky

et al. 2014

American Journal of Gastroenterology

680

656

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“…Benoxaprofen and bromfenac are two NSAIDs that were withdrawn from public use after reports of hepatotoxicity [16,19]. Benoxaprofen was withdrawn in 1982, the same year that it was approved [16].…”

Section: Attrition Due To Hepatotoxicitymentioning

confidence: 99%