European Journal of Epidemiology

, Volume 20, Issue 2, pp 127–129 | Cite as

Ten lessons to be learned from the withdrawal of Vioxx® (rofecoxib)

  • Xavier Carné
  • Núria Cruz


Public Health Infectious Disease Rofecoxib 
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  1. Pirmohamed, M, James, S, Meakin, S,  et al. 2004Adverse drug reactions as a cause of admission to hospital: prospective analysis of 18820 patients.Br Med J3241519Google Scholar
  2. Martin, MT, Codina, C, Tuset, M, Carné, X, Nogué, S, Ribas, J 2002Problemas relacionados con la medicación como causa del ingreso hospitalario.Med Clin (Barc)118205210Google Scholar
  3. Laporte, JR, Carné, X, Vidal, X,  et al. 1991Upper gastrointestinal bleeding in relation to previous use of analgesic and non-steroidal anti-inflammatory drugs.Lancet3378589CrossRefPubMedGoogle Scholar
  4. Langman, MJS, Weil, J, Wainwright, P,  et al. 1994Risks of bleeding peptic ulcer associated with individual non-steroidal anti-inflammatory drugs.Lancet34310751078CrossRefPubMedGoogle Scholar
  5. Lanas, A, Bajador, E, Serrano, P,  et al. 2000Nitrovasodilators, low-dose aspirin, other nonsteroidal antiinflammatory drugs and the risk of upper gastrointestinal bleeding.N Engl J Med343834839Google Scholar
  6. Henry, D, Lim, LL-Y, García, Rodríguez LA,  et al. 1996Variability in risk of gastrointestinal complications with individual non-steroidal anti-inflammatory drugs: results of a collaborative meta-analysis.Br Med J31215631566Google Scholar
  7. Hernández-Díaz, S, García-Rodríguez, LA 2000Association between nonsteroidal anti-inflammatory drugs and upper gastrointestinal tract bleeding/perforation: An overview of epidemiologic studies published in the 1990s.Arch Intern Med16020932099CrossRefPubMedGoogle Scholar
  8. Laporte, JR, Ibañez, L, Vidal, X, Vendrell, L, Leone, R 2004Upper gastrointestinal bleeding associated with the use of NSAIDs.Drug Safety27411420Google Scholar
  9. FitzGerald, GA, Patrono, C 2001The coxibs, selective inhibitors of cyclooxygenase-2.N Engl J Med345433442CrossRefPubMedGoogle Scholar
  10. FitzGerald, GA 2004Coxibs and cardiovascular disease.N Engl J Med35117091711Google Scholar
  11. Topol, EJ 2004Failing the public health. Rofecoxib, Merck and the FDA.N Engl J Med35117071709Google Scholar
  12. Bombardier, C, Laine, L, Reicin, A,  et al. 2000for the VIGOR Study Group. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis.N Engl J Med34315201528CrossRefPubMedGoogle Scholar
  13. Farkouh, ME, Kirshner, H, Harrington, RA,  et al. 2004on behalf of the TARGRT Study Group.Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), cardiovascular outcome: Randomised controlled trial. Lancet364675684Google Scholar
  14. Konstam, MA, Weir, MR, Reicin, A,  et al. 2001Cardiovascular thrombotic events in controlled, clinical trials of rofecoxib.Circulation10222802288Google Scholar
  15. Rahme, E, Pilote, L, LeLorier, J 2002Association between naproxen use and protection against acute myocardial infraction.Arch Intern Med16211111115Google Scholar
  16. Solomon, DH, Glynn, RJ, Levin, R, Avorn, J 2002Nonsteroidal anti-inflammatory drug use and acute myocardial infraction.Arch Intern Med16210991104Google Scholar
  17. Watson, DJ, Rhodes, T, Cai, B, Guess, HA 2002Lower risk of thromboembolic cardiovascular events with naproxen among patients with rheumatoid arthritis.Arch Intern Med16211051110Google Scholar
  18. Solomon, DH, Schneeweiss, S, Glynn, RJ,  et al. 2003Relationship between selective cyclooxigenase-2 inhibitors and acute myocardial infarction in older adults.Circulation10920682073Google Scholar
  19. White, WB, Faich, G, Borer, JS, Makuch, RW 2003Cardiovascular thrombotic events in arthritis trials of the cyclooxygenase-2 inhibitor celecoxib.Am J Cardiol92411418CrossRefPubMedGoogle Scholar
  20. White, WB, Faich, G, Whelton, A,  et al. 2002Comparison of thromboembolic events in patients treated with celecoxib, a cyclooxigenase-2 specific inhibitor, versus ibuprofen or diclofenac.Am J Cardiol89425430CrossRefPubMedGoogle Scholar
  21. Oberholzer-Gee, F, Inamdar, SN 2004Merck’s recall of rofecoxib. A strategic perspective.N Engl J Med35121472149Google Scholar
  22. Jüni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 2004; 364: 2021–2029.Google Scholar
  23. Horton R. Vioxx, the implosion of Merck, and aftershocks at the FDA. Lancet 2004; 364: 1995–1996.Google Scholar

Copyright information

© Springer 2005

Authors and Affiliations

  • Xavier Carné
    • 1
  • Núria Cruz
    • 1
  1. 1.Servei de Farmacologia Clínica, Unitat d’Avaluació, Suport i PrevencióInstitut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)BarcelonaSpain

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