FREE NEJM E-TOC    HOME   |   SUBSCRIBE   |   CURRENT ISSUE   |   PAST ISSUES   |   COLLECTIONS   |   Search Term  Advanced Search

Sign in | Get NEJM's E-Mail Table of Contents — Free | Subscribe

Volume 351:1707-1709 October 21, 2004 Number 17 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

	Full Text PDF PDA Full Text Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

On May 21, 1999, Merck was granted approval by the Food and Drug Administration (FDA) to market rofecoxib (Vioxx). On September 30, 2004, after more than 80 million patients had taken this medicine and annual sales had topped $2.5 billion, the company withdrew the drug because of an excess risk of myocardial infarctions and strokes. This represents the largest prescription-drug withdrawal in history, but had the many warning signs along the way been heeded, such a debacle could have been prevented.

Neither of the two major forces in this five-and-a-half-year affair — neither Merck nor the FDA — fulfilled its . . . [Full Text of this Article]

Source Information

From the Cleveland Clinic Foundation, Cleveland.

Related Letters:

Rofecoxib, Merck, and the FDA
Kim P. S., Reicin A. S., Villalba L., Witter J., Wolfe M. M., Topol E. J.
Extract | Full Text | PDF  
N Engl J Med 2004; 351:2875-2878, Dec 30, 2004. Correspondence

This article has been cited by other articles:

• SRINIVAS, S., FELDMAN, D. (2009). A Phase II Trial of Calcitriol and Naproxen in Recurrent Prostate Cancer. Anticancer Res 29: 3605-3610 [Abstract] [Full Text]  
• Irwin, R. S. (2009). The Role of Conflict of Interest in Reporting of Scientific Information. Chest 136: 253-259 [Abstract] [Full Text]  
• Currie, J. A, Preston, H., Weerapperuma, S. (2009). EC, don't let drug companies give information to the public. BMJ 338: b290-b290 [Full Text]  
• Mintzes, B. (2008). Direct to consumer advertising of prescription drugs. BMJ 337: a985-a985 [Full Text]  
• Pisacane, A. (2008). Rethinking continuing medical education. BMJ 337: a973-a973 [Full Text]  
• Vasen, H F A, Moslein, G, Alonso, A, Aretz, S, Bernstein, I, Bertario, L, Blanco, I, Bulow, S, Burn, J, Capella, G, Colas, C, Engel, C, Frayling, I, Friedl, W, Hes, F J, Hodgson, S, Jarvinen, H, Mecklin, J-P, Moller, P, Myrhoi, T, Nagengast, F M, Parc, Y, Phillips, R, Clark, S K, de Leon, M P., Renkonen-Sinisalo, L, Sampson, J R, Stormorken, A, Tejpar, S, Thomas, H J W, Wijnen, J (2008). Guidelines for the clinical management of familial adenomatous polyposis (FAP). Gut 57: 704-713 [Abstract] [Full Text]  
• Carpenter, D., Zucker, E. J., Avorn, J. (2008). Drug-Review Deadlines and Safety Problems. NEJM 358: 1354-1361 [Abstract] [Full Text]  
• Lee, K. (2008). Has the hunt for conflicts of interest gone too far? No. BMJ 336: 477-477 [Full Text]  
• Dhalla, I. MD, Laupacis, A. MD MSc (2008). Moving from opacity to transparency in pharmaceutical policy. CMAJ 178: 428-431 [Full Text]  
• Pearce, N. (2008). Corporate influences on epidemiology. Int J Epidemiol 37: 46-53 [Abstract] [Full Text]  
• Turner, E. H., Matthews, A. M., Linardatos, E., Tell, R. A., Rosenthal, R. (2008). Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy. NEJM 358: 252-260 [Abstract] [Full Text]  
• Sade, R. M., Grande, D., Gorske, A. L., Campbell, E. G. (2007). A National Survey of Physician-Industry Relationships. NEJM 357: 507-508 [Full Text]  
• O'Byrne, K. J., Danson, S., Dunlop, D., Botwood, N., Taguchi, F., Carbone, D., Ranson, M. (2007). Combination Therapy With Gefitinib and Rofecoxib in Patients With Platinum-Pretreated Relapsed Non Small-Cell Lung Cancer. JCO 25: 3266-3273 [Abstract] [Full Text]  
• Abraham, J., Davis, C. (2007). Deficits, Expectations and Paradigms in British and American Drug Safety Assessments: Prising Open the Black Box of Regulatory Science. Science Technology Human Values 32: 399-431 [Abstract]  
• Cavalieri, T. A. (2007). Managing Pain in Geriatric Patients. JAOA: Journal of the American Osteopathic Association 107: ES10-ES16 [Abstract] [Full Text]  
• Bennett, C. L., Nebeker, J. R., Yarnold, P. R., Tigue, C. C., Dorr, D. A., McKoy, J. M., Edwards, B. J., Hurdle, J. F., West, D. P., Lau, D. T., Angelotta, C., Weitzman, S. A., Belknap, S. M., Djulbegovic, B., Tallman, M. S., Kuzel, T. M., Benson, A. B., Evens, A., Trifilio, S. M., Courtney, D. M., Raisch, D. W. (2007). Evaluation of Serious Adverse Drug Reactions: A Proactive Pharmacovigilance Program (RADAR) vs Safety Activities Conducted by the Food and Drug Administration and Pharmaceutical Manufacturers. Arch Intern Med 167: 1041-1049 [Abstract] [Full Text]  
• Antman, E. M., Bennett, J. S., Daugherty, A., Furberg, C., Roberts, H., Taubert, K. A. (2007). Use of Nonsteroidal Antiinflammatory Drugs: An Update for Clinicians: A Scientific Statement From the American Heart Association. Circulation 115: 1634-1642 [Full Text]  
• Rostom, A., Dube, C., Lewin, G., Tsertsvadze, A., Barrowman, N., Code, C., Sampson, M., Moher, D. (2007). Nonsteroidal Anti-inflammatory Drugs and Cyclooxygenase-2 Inhibitors for Primary Prevention of Colorectal Cancer: A Systematic Review Prepared for the U.S. Preventive Services Task Force. ANN INTERN MED 146: 376-389 [Abstract] [Full Text]  
• Zarraga, I. G. E., Schwarz, E. R. (2007). Coxibs and Heart Disease: What We Have Learned and What Else We Need to Know. J Am Coll Cardiol 49: 1-14 [Abstract] [Full Text]  
• Swami, S., Krishnan, A. V., Moreno, J., Bhattacharyya, R. B., Peehl, D. M., Feldman, D. (2007). Calcitriol and Genistein Actions to Inhibit the Prostaglandin Pathway: Potential Combination Therapy to Treat Prostate Cancer. J. Nutr. 137: 205S-210S [Abstract] [Full Text]  
• Gitlin, J. M., Trivedi, D. B., Langenbach, R., Loftin, C. D. (2007). Genetic deficiency of cyclooxygenase-2 attenuates abdominal aortic aneurysm formation in mice. Cardiovasc Res 73: 227-236 [Abstract] [Full Text]  
• Ruiz Cantero, M. T., Pardo, M. A. (2006). European Medicines Agency policies for clinical trials leave women unprotected.. J. Epidemiol. Community Health 60: 911-913 [Full Text]  
• Aberegg, S. K., Arkes, H., Terry, P. B. (2006). Failure to Adopt Beneficial Therapies Caused by Bias in Medical Evidence Evaluation. Med Decis Making 26: 575-582 [Abstract]  
• Graham, D. J. (2006). COX-2 Inhibitors, Other NSAIDs, and Cardiovascular Risk: The Seduction of Common Sense. JAMA 296: 1653-1656 [Full Text]  
• Bradford, W. D., Kleit, A. N., Nietert, P. J., Steyer, T., McIlwain, T., Ornstein, S. (2006). How Direct-To-Consumer Television Advertising For Osteoarthritis Drugs Affects Physicians' Prescribing Behavior. Health Aff (Millwood) 25: 1371-1377 [Abstract] [Full Text]  
• Leshnower, B. G., Sakamoto, H., Zeeshan, A., Parish, L. M., Hinmon, R., Plappert, T., Jackson, B. M., Gorman, J. H. III, Gorman, R. C. (2006). Role of acetaminophen in acute myocardial infarction. Am. J. Physiol. Heart Circ. Physiol. 290: H2424-H2431 [Abstract] [Full Text]  
• Brown, S. D., Daly, J. C., Kalish, L. A., McDaniel, S. A. (2006). Financial Disclosures of Scientific Papers Presented at the 2003 RSNA Annual Meeting: Association with Reporting of Non-Food and Drug Administration-approved Uses of Industry Products. Radiology 239: 849-855 [Abstract] [Full Text]  
• Roth-Cline, M. D. (2006). Clinical Trials in the Wake of Vioxx: Requiring Statistically Extreme Evidence of Benefit to Ensure the Safety of New Drugs. Circulation 113: 2253-2259 [Full Text]  
• Popp, R. L., Lorell, B. H., Stone, G. W., Laskey, W., Smith, J. J., Kaplan, A. V. (2006). An Outline for Public Registration of Clinical Trials Evaluating Medical Devices. J Am Coll Cardiol 47: 1518-1521 [Abstract] [Full Text]  
• Sooriakumaran, P (2006). COX-2 inhibitors and the heart: are all coxibs the same?. Postgrad. Med. J. 82: 242-245 [Abstract] [Full Text]  
• Papanikolaou, P. N., Christidi, G. D., Ioannidis, J. P.A. (2006). Comparison of evidence on harms of medical interventions in randomized and nonrandomized studies. CMAJ 174: 635-641 [Abstract] [Full Text]  
• Ioannidis, J. P.A., Mulrow, C. D., Goodman, S. N. (2006). Adverse events: the more you search, the more you find.. ANN INTERN MED 144: 298-300 [Full Text]  
• Ray, W. A., Stein, C. M. (2006). Reform of Drug Regulation -- Beyond an Independent Drug-Safety Board. NEJM 354: 194-201 [Full Text]  
• Abraham, J. (2005). Regulating the drugs industry transparently. BMJ 331: 528-529 [Full Text]  
• Genuis, S. J. (2005). The Proliferation of Clinical Practice Guidelines: Professional Development or Medicine-by-Numbers?. J Am Board Fam Med 18: 419-425 [Abstract] [Full Text]  
• Hudson, M., Richard, H., Pilote, L. (2005). Differences in outcomes of patients with congestive heart failure prescribed celecoxib, rofecoxib, or non-steroidal anti-inflammatory drugs: population based study. BMJ 330: 1370- [Abstract] [Full Text]  
• Freudenberg, N. (2005). Public Health Advocacy to Change Corporate Practices: Implications for Health Education Practice and Research. Health Educ Behav 32: 298-319 [Abstract]  
• Blackstone, E. H. (2005). Could It Happen Again?: The Bjork-Shiley Convexo-Concave Heart Valve Story. Circulation 111: 2717-2719 [Full Text]  
• Mello, M. M., Clarridge, B. R., Studdert, D. M. (2005). Academic Medical Centers' Standards for Clinical-Trial Agreements with Industry. NEJM 352: 2202-2210 [Abstract] [Full Text]  
• Sin, D. D., Man, P., Lacy, P., York, E. (2005). Fluticasone Reduces CRP in COPD. Am. J. Respir. Crit. Care Med. 171: 1191-1192 [Full Text]  
• Bennett, C. L., Nebeker, J. R., Lyons, E. A., Samore, M. H., Feldman, M. D., McKoy, J. M., Carson, K. R., Belknap, S. M., Trifilio, S. M., Schumock, G. T., Yarnold, P. R., Davidson, C. J., Evens, A. M., Kuzel, T. M., Parada, J. P., Cournoyer, D., West, D. P., Sartor, O., Tallman, M. S., Raisch, D. W. (2005). The Research on Adverse Drug Events and Reports (RADAR) Project. JAMA 293: 2131-2140 [Abstract] [Full Text]  
• Andreotti, F., Crea, F. (2005). Substandard life-saving drugs: a global concern. Eur Heart J 26: 858-860 [Full Text]  
• Fredy, J., Diggins, D. A Jr, Morrill, G. B (2005). Blood Pressure in Native Americans Switched from Celecoxib to Rofecoxib. The Annals of Pharmacotherapy 39: 797-802 [Abstract] [Full Text]  
• Kritchevsky, S. B., Cesari, M., Pahor, M. (2005). Inflammatory markers and cardiovascular health in older adults. Cardiovasc Res 66: 265-275 [Abstract] [Full Text]  
• Sackner-Bernstein, J. D., Kowalski, M., Fox, M., Aaronson, K. (2005). Short-term Risk of Death After Treatment With Nesiritide for Decompensated Heart Failure: A Pooled Analysis of Randomized Controlled Trials. JAMA 293: 1900-1905 [Abstract] [Full Text]  
• Fukunaga, K., Kohli, P., Bonnans, C., Fredenburgh, L. E., Levy, B. D. (2005). Cyclooxygenase 2 Plays a Pivotal Role in the Resolution of Acute Lung Injury. J. Immunol. 174: 5033-5039 [Abstract] [Full Text]  
• Bennett, J. S., Daugherty, A., Herrington, D., Greenland, P., Roberts, H., Taubert, K. A. (2005). The Use of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): A Science Advisory From the American Heart Association. Circulation 111: 1713-1716 [Full Text]  
• Eisenberg, R. S. (2005). Learning the Value of Drugs -- Is Rofecoxib a Regulatory Success Story?. NEJM 352: 1285-1287 [Full Text]  
• Solomon, S. D., McMurray, J. J.V., Pfeffer, M. A., Wittes, J., Fowler, R., Finn, P., Anderson, W. F., Zauber, A., Hawk, E., Bertagnolli, M., the Adenoma Prevention with Celecoxib (APC) Study, (2005). Cardiovascular Risk Associated with Celecoxib in a Clinical Trial for Colorectal Adenoma Prevention. NEJM 352: 1071-1080 [Abstract] [Full Text]  
• Cavalieri, T. A. (2005). Management of Pain in Older Adults. JAOA: Journal of the American Osteopathic Association 105: 12S-17S [Abstract] [Full Text]  
• Jain, A., Atreja, A., Harris, C. M., Lehmann, M., Burns, J., Young, J. (2005). Responding to the Rofecoxib Withdrawal Crisis: A New Model for Notifying Patients at Risk and Their Health Care Providers. ANN INTERN MED 142: 182-186 [Abstract] [Full Text]  
• Khatami, M., Mulshine, J. (2005). Cyclooxygenase Inhibitor Ketorolac or Mast Cell Stabilizers: Immunologic Challenges in Cancer Therapy. Clin. Cancer Res. 11: 1350-1352 [Full Text]  
• Iadecola, C., Gorelick, P. B. (2005). The Janus Face of Cyclooxygenase-2 in Ischemic Stroke: Shifting Toward Downstream Targets. Stroke 36: 182-185 [Full Text]  
• Chang, I. J., Harris, R. C. (2005). Are All COX-2 Inhibitors Created Equal?. Hypertension 45: 178-180 [Full Text]  
• Roden, D. M. (2005). An Underrecognized Challenge in Evaluating Postmarketing Drug Safety. Circulation 111: 246-248 [Full Text]  
• Topol, E. J. (2005). Arthritis Medicines and Cardiovascular Events--"House of Coxibs". JAMA 293: 366-368 [Full Text]  
• Rabausch, K., Bretschneider, E., Sarbia, M., Meyer-Kirchrath, J., Censarek, P., Pape, R., Fischer, J. W., Schror, K., Weber, A.-A. (2005). Regulation of Thrombomodulin Expression in Human Vascular Smooth Muscle Cells by COX-2-Derived Prostaglandins. Circ. Res. 96: e1-e6 [Abstract] [Full Text]  
• Kim, P. S., Reicin, A. S., Villalba, L., Witter, J., Wolfe, M. M., Topol, E. J. (2004). Rofecoxib, Merck, and the FDA. NEJM 351: 2875-2878 [Full Text]  
• Fontanarosa, P. B., Rennie, D., DeAngelis, C. D. (2004). Postmarketing Surveillance--Lack of Vigilance, Lack of Trust. JAMA 292: 2647-2650 [Full Text]  
• (2004). The Next Chapter in the COX-2 Saga. Journal Watch Cardiology 2004: 2-2 [Full Text]  
• (2004). Perspective on the Vioxx Recall. JWatch General 2004: 1-1 [Full Text]