Observational studies and the withdrawal of Rofecoxib

Pharmacoepidemiology and Drug Safety

Volumn 15, Issue 3, 2006, Pages 199-201

  Watson, Douglas J ^a   Santanello, Nancy C ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CELECOXIB; CYCLOOXYGENASE 2 INHIBITOR; NAPROXEN; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; ROFECOXIB;

CARDIOVASCULAR DISEASE; CLINICAL TRIAL; DRUG CONTRAINDICATION; DRUG DOSE REGIMEN; DRUG WITHDRAWAL; FOOD AND DRUG ADMINISTRATION; HEALTH CARE QUALITY; HEART INFARCTION; HUMAN; ISCHEMIC HEART DISEASE; LONG TERM CARE; MEDICAL DECISION MAKING; NOTE; OBSERVATIONAL STUDY; PEER REVIEW; PRIORITY JOURNAL; PUBLICATION; RISK ASSESSMENT; THROMBOSIS;

CLINICAL TRIALS; CLINICAL TRIALS AS TOPIC; CYCLOOXYGENASE 2 INHIBITORS; DATA INTERPRETATION, STATISTICAL; DRUG LABELING; HUMANS; LACTONES; MYOCARDIAL INFARCTION; OBSERVATION; PHARMACOEPIDEMIOLOGY; PRODUCT SURVEILLANCE, POSTMARKETING; RISK ASSESSMENT; SULFONES; THROMBOEMBOLISM;

EID: 33645318163     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1219     Document Type: Note

References (23)

1. Arellano FM. The withdrawal of rofecoxib. PD Safe 2005; 14: 213-217.
2. Bresalier RS, Sandler RS, Quan H, Bolognese JA, Oxenius B, Horgan K, et al. for the Adenomatous Polyp Prevention on Vioxx (APPROVe) Trial Investigators. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 2005; published at www.nejm.org on Feb 15, 2005 (10.1056/NEJMoa050493).
3. Ray WA, Stein CM, Daugherty JR, Hall K, Abrogast PG, Griffin MR. COX-2 selective non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease. Lancet 2002; 360: 1071-1073.
4. Mamdani M, Rochon P, Juurlink DN, et al. Effect of COX-2 selective cyclooxygenase inhibitors on short term risk of acute myocardial infarction in the elderly. Arch Int Med 2003; 163: 481-486.
5. Solomon DH, Schneeweiss MD, Glynn RJ, Kiyota Y, Levin R, Mogun H. Relationship between selective cyclooxygenase-2 inhibitors and acute myocardial infarction in older adults. Circulation 2004; 109: 2068-2073.
6. Levy GD, Cheetham C, Shoor S. Cohort analysis of myocardial risk and COX-2 in the Kaiser Large Observational Thrombosis Study (KLOTS). Arthritis Rheum 2002; 46(Suppl. 9): 5377.
7. Kimmel SE, Berlin JA, Reilly M, Jaskowiak J, Kishel L, Strom BL. Risk of myocardial infarction by type of cyclooxygenase-2 inhibitor. [Abstract]. Circulation 2003; 108(17, Suppl. IV): IV 752.
8. Rahme E, Kong SX, Watson DJ, Toubouti Y, LeLorier J. Association between rofecoxib, diclofenac/ibuprofen and hospitalization for acute myocardial infarction. PD Safe 2004; 13: S235.
9. Shaya FT, Blume SW, Blanchette CM, Mullins CD, Weir MR. Cardiovascular risk of selective cyclooxygenase-2 inhibitors compared to other nonsteroidal anti-inflammatory agents: an observational study of a Medicaid population. PD Safe 2004; 13: S234-235.
10. Graham DJ, Campen D, Cheetham C, Hui R, Spence M, Ray WA. Risk of acute cardiac events among patients treated with cyclooxygenase-2 selective and non-selective nonsteroidal anti-inflammatory drugs. PD Safe 2004; 13: S287-288.
11. Campen DH, Graham D, Cheetham C, et al. Risk of acute cardiac events among patients treated with cyclooygenase-2 selective and non-selective-nonsteroidal anti-inflammatory drugs. Arthritis Rheum 2004; 50(Suppl. 9): S657.
12. Temple R. Meta-analysis and epidemiologic studies in drug development and postmarketing surveillance. JAMA 1999; 281(9): 841-844.
13. Minutes of Arthritis Drug Advisory Committee, February 16-18, 2005 Joint Meeting with the Drug Safety and Risk Management Advisory Committee. http://www.fda.gov/ohrms/dockets/ac/05/minutes/2005-4090M1_Final.htm. (accessed April 8, 2005)
14. Bradford-Hill A. The environment and disease: association or causation? President's Address. Proc Royal Soc Med 1965; 9: 295-300.
15. Stampfer MJ, Willett WC, Colditz GA, Rosner B, Speizer FE, Hennekens CH. A prospective study of postmenopausal estrogen therapy and coronary heart disease. NEJM 1985; 313: 1044-1049.
16. Stampfer MJ, Colditz G. Estrogen replacement therapy and coronary heart disease: a quantitative assessment of the epidemiologic evidence. Prev Med 1991; 20: 47-63.
17. Stampfer MJ, Colditz GA, Willett WC, et al. Postmenopausal estrogen therapy and cardiovascular disease: ten-year follow-up from the Nurses' Health Study. NEJM 1991; 325: 756-762.
18. Barrett-Connor E. Hormone replacement therapy, heart disease, and other considerations. Ann Review Public Health 1998; 19: 55-72.
19. Hulley S, Grady D, Bush T, et al. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. JAMA 1998; 280: 605-613.
20. FDA Statement on the Results of the Women's Health Initiative (13 Aug 2002). Women's health initiative (WHI) results signal need for reassessment of risks and benefits of conjugated equine estrogens/medroxyprogesterone acetate (prempro) in postmenopausal women. http://www.fda.gov/cder/drug/safety/WHI_statement.htm (accessed 20 March 2005).
21. Grady D, Herrington D, Bittner V, et al. Cardiovascular disease outcomes during 6.8 years of hormone therapy. Heart and estrogen/progestin replacement study follow-up (HERS II). JAMA 2002; 288: 49-57.
22. Rossouw JE, Anderson GL, Prentice RL, et al. for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA 2002; 288: 321-333.
23. FDA news release issued on 1 Jan 2003. http:www.fda.gov/bbs/topics/NEWS/2003/NEW00863.html (accessed 20 Mar 2005)