Observational studies and the withdrawal of rofecoxib

Pharmacoepidemiology and Drug Safety

Volumn 15, Issue 3, 2006, Pages 203-205

  Arellano, Félix M ^a,b  

^a Risk Management Resources   (United States)

^b UNIVERSITY OF NEW SOUTH WALES   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

CELECOXIB; NONSTEROID ANTIINFLAMMATORY AGENT; ROFECOXIB;

CLINICAL PRACTICE; CLINICAL TRIAL; DRUG DOSE REGIMEN; DRUG WITHDRAWAL; EPIDEMIOLOGICAL DATA; FOOD AND DRUG ADMINISTRATION; HEART INFARCTION; HUMAN; MEDICAL DECISION MAKING; META ANALYSIS; NOTE; OBSERVATIONAL STUDY; PRIORITY JOURNAL; RISK ASSESSMENT; STATISTICAL SIGNIFICANCE; SYSTEMATIC REVIEW; THROMBOEMBOLISM;

EID: 33645309368     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1220     Document Type: Note

References (16)

1. Watson DJ, Santanello N. Observational studies and the withdrawal of rofecoxib. PD Safe 2006; 15: 199-201.
2. Arellano FM. The withdrawal of rofecoxib. PD Safe 2005; 14: 213-217.
3. Solomon DH, Schneweis S, Glynn RJ, et al. Relationship between selective cyclo-oxygenase-2 inhibitors and acute myocardial infarction in older adults. Circulation 2004; 109: 2068-2073.
4. Rothman KJ. Lessons from John Graunt. Lancer 1996; 347: 37-39.
5. Arellano FM, Castellsague J. (Un)learned lessons from Ken Rothman. A CLASSic example. Clin Ther 2003; 25: 2891-2896.
6. Bresalier R, Sandler RS, Quan H, et al. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 2005; 352: 1092-1102.
7. Bombardier C, Lain L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000; 343: 520-528.
8. Konstam MA, Weir MR, Reicin A, et al. Cardiovascular thrombotic events in controlled clinical trials of rofecoxib. Circulation 2001; 104: 2280-2288.
9. Ray WA, Stein M, Hall K, et al. Non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease: an observational cohort study. Lancer 2002; 359: 118-123.
10. Graham DJ, Campen DH, Hui R, et al. Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study. Lancet 2005; 365: 475-481.
11. Levesque LE, Brophy JM, Zhang B. The risk for myocardial infarction with cyclooxygenase-2 inhibitors: a population study of elderly adults. Ann Intern Med 2005; 142: 481-489.
12. Kimmel SE, Berlin JA, Reilly M, et al. Patients exposed to rofecoxib and celecoxib have different odds of nonfatal myocardial infarction. Ann Intern Med 2005; 142: 157-164.
13. Mamdami M, Rochon P, Juurlink DN, et al. Effect of selective cyclo-oxygenase inhibitors and naproxen on short-term risk of acute myocardial infarction in the elderly. Arch Intern Med 2003; 163: 481-486.
14. Vioxx® prescribing information. http://www.vioxx.com/rofecoxib/vioxx/consumer /prescribing_jnformation.jsp. Last visited October 2nd 2004.
15. Arellano FM, Ulcickas-Yood M, Wentworth CE, et al. Use of cyclo-oxygenase 2 inhibitors (COX-2) and non-steroidal anti-inflammatory drugs (NSAID) in a UK and a USA populations. Implications for COX-2 cardiovascular profile. Submitted for publication.
16. Drazen JM. COX-2 inhibitors - a lesson in unexpected problems. N Engl J Med 2005; 352: 1131-1132.