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Spontaneous Reports of Hypertension Leading to Hospitalisation in Association with Rofecoxib, Celecoxib, Nabumetone and Oxaprozin

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Abstract

Background and objective

Data on file with the US FDA, and other published studies, suggest that the selective cyclo-oxygenase (COX)-2 inhibitor NSAID rofecoxib has a greater hypertensive adverse effect than other NSAIDs, including celecoxib. In this study we describe a pharmacoepidemiologic analysis of spontaneous adverse event reports of acute, clinically serious hypertension (as defined by hospitalisation) reported in association with rofecoxib, celecoxib, nabumetone and oxaprozin. The objective of this analysis is to assess whether postmarketing data are consistent with results of clinical trials. We also collapse cases into series for the identification of possible risk factors for clinically severe, NSAID-associated hypertension.

Methods

Domestic (US) cases of apparently unconfounded, acute hypertension leading to hospitalisation were collected and reviewed from the spontaneous adverse events database of the FDA for rofecoxib, celecoxib, nabumetone and oxaprozin for the initial 3 years of marketing. Drug use data for the same intervals enabled calculation of reporting rates.

Results

In an analysis of reporting rates, hospitalisation for acute blood pressure (BP) elevation was reported more frequently (3.8-fold) for rofecoxib compared with celecoxib. A total of 34 cases are collapsed into case series. No cases were identified for either nabumetone or oxaprozin. Inspection of reviewed cases for celecoxib and rofecoxib suggest that these patients (average age 72 years) were potentially high-risk candidates for NSAID therapy.

Discussion and conclusion

During early marketing, hospitalisation for acute BP elevation appears to have been reported more frequently for rofecoxib compared with celecoxib. This is consistent with clinical trial data on file with the FDA, and other published studies that found rofecoxib to have a greater effect on BP than other NSAIDs, including celecoxib. This finding may be particularly relevant in older patients given the prevalence of hypertension and cardiovascular disease in this age group.

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Notes

  1. The use of trade names is for product identification purposes only and does not imply endorsement.

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Acknowledgements

The authors were employees of the US Government at the time this study was conducted and received no direct funding, nor declare any conflict of interest relevant to this research effort. The views expressed are those of the authors and do not necessarily represent those of the US FDA or imply its endorsement.

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Authors and Affiliations

  1. Division of Drug Risk Evaluation, Office of Drug Safety, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland, 20857, USA

    Allen Brinker, Renan Bonnel & Julie Beitz

  2. Division of Anti-inflammatory, Office of Drug Evaluation V, Analgesic and Ophthalmologic Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland, USA

    Lawrence Goldkind

Authors
  1. Allen Brinker
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  2. Lawrence Goldkind
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  3. Renan Bonnel
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  4. Julie Beitz
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Correspondence to Allen Brinker.

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Brinker, A., Goldkind, L., Bonnel, R. et al. Spontaneous Reports of Hypertension Leading to Hospitalisation in Association with Rofecoxib, Celecoxib, Nabumetone and Oxaprozin. Drugs Aging 21, 479–484 (2004). https://doi.org/10.2165/00002512-200421070-00005

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  • DOI: https://doi.org/10.2165/00002512-200421070-00005

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