Evidence-Based Safety Reassessment of Post Marketed Drug - Importance of Recall of Refecoxib_Chinese Journal of Evidence-Based Medicine

Authors：

HU Da yi , YANG Jin gang

Beijing Tongren Hospital Cardiovascular Center; Capital University of Medical Sciences; Beijing 100073; China;

Corresponding author：

Keywords：

Refecoxib; Adverse reaction; Post marked monitoring of drug safety

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

This article aims to review the recall of refecoxib which increases the incidence of cardiovascular and cerebrovascular diseases and to find the methods to solve problems in post marked monitoring of drug safety.

Citation： HU Da yi,YANG Jin gang. Evidence-Based Safety Reassessment of Post Marketed Drug - Importance of Recall of Refecoxib. Chinese Journal of Evidence-Based Medicine, 2005, 05(2): 94-96. doi: Copy

1.	Hunt RH, Bowen B, Mortensen ER, Simon TJ, James C, Cagliola A, Quan H, Bolognese JA.A randomized trial measuring fecal blood loss after treatment with refecoxib, ibuprofen, or placebo in healthy subjects[J]. Am J Med, 2000;109(3): 201-206.
2.	Department of Health and Ageing. Consumer level recall of arthritis drug[R]. Available from URL: http://www.tga.gov.au/media/2004/040930_vioxx.htm, 2004;10.
3.	Mamdani M, Rochon PA, Juurlink DN, Kopp A, Anderson GM, Naglie G, Peter C Austin, Andreas Laupacis. Observational study of upper gastrointestinal haemorrhage in elderly patients given selective cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs[J]. BMJ, 2002;325(7 365): 624.
4.	Topol EJ. Failing the public health-Refecoxib, Merck, and the FDA[J]. New Eng J Med, 2004;1 466(351): 1 707-1 709.
5.	Khan KN, Paulson SK, Verburg KM, Lefkowith JB, Maziasz TJ. Pharmacology of Cyclooxygenase-2 inhibition in the kidney[J]. Kidney Int, 2002;61(4): 1 210-1 219.
6.	Layton D, Riley J, Wilton LV, Shakir SA. Safety profile of refecoxib as used in general practice in England: results of a prescription-event monitoring study[J]. Br J Clin Pharmacol, 2003;55(23): 166-174.
7.	Fendrick AM, Garabedian-Ruffalo SM. A clinician’s guide to the selection of NSAID therapy[J]. P & T, 2002;53(27): 579- 582.
8.	Cox ER, Frisse M, Behm A, Fairman KA. Over-the-counter pain reliever and aspirin use within a sample of long-term cyclooxygenase-2 users[J]. Arch Intern Med, 2004;456(164): 1 243- 1 246.
9.	Chan FK, Hung LC, Suen BY. Celecoxib versus diclofenac and omeprazole in reducing the risk of recurrent ulcer bleeding in patients with arthritis[J]. N Engl J Med, 2002;847(347): 2 104- 2 110.
10.	Bjordal JM, Ljunggren AE, Klovning A, Slordal L. Non-steroidal anti-inflammatory drugs, including cyclooxygenase-2 inhibitors, in osteoarthritic knee pain: meta-analysis of randomized placebo controlled trials[J]. BMJ, 2004;329(7 478): 1 317.
11.	Dieppe P, Bartlett C ,Davey P, Doyal L, Ebrahim S. Balancing benefits and harms: the example of non-steroidal anti-inflammatory drugs[J]. BMJ, 2004;2 562(329): 31-34.

1. Hunt RH, Bowen B, Mortensen ER, Simon TJ, James C, Cagliola A, Quan H, Bolognese JA.A randomized trial measuring fecal blood loss after treatment with refecoxib, ibuprofen, or placebo in healthy subjects[J]. Am J Med, 2000;109(3): 201-206.
2. Department of Health and Ageing. Consumer level recall of arthritis drug[R]. Available from URL: http://www.tga.gov.au/media/2004/040930_vioxx.htm, 2004;10.
3. Mamdani M, Rochon PA, Juurlink DN, Kopp A, Anderson GM, Naglie G, Peter C Austin, Andreas Laupacis. Observational study of upper gastrointestinal haemorrhage in elderly patients given selective cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs[J]. BMJ, 2002;325(7 365): 624.
4. Topol EJ. Failing the public health-Refecoxib, Merck, and the FDA[J]. New Eng J Med, 2004;1 466(351): 1 707-1 709.
5. Khan KN, Paulson SK, Verburg KM, Lefkowith JB, Maziasz TJ. Pharmacology of Cyclooxygenase-2 inhibition in the kidney[J]. Kidney Int, 2002;61(4): 1 210-1 219.
6. Layton D, Riley J, Wilton LV, Shakir SA. Safety profile of refecoxib as used in general practice in England: results of a prescription-event monitoring study[J]. Br J Clin Pharmacol, 2003;55(23): 166-174.
7. Fendrick AM, Garabedian-Ruffalo SM. A clinician’s guide to the selection of NSAID therapy[J]. P & T, 2002;53(27): 579- 582.
8. Cox ER, Frisse M, Behm A, Fairman KA. Over-the-counter pain reliever and aspirin use within a sample of long-term cyclooxygenase-2 users[J]. Arch Intern Med, 2004;456(164): 1 243- 1 246.
9. Chan FK, Hung LC, Suen BY. Celecoxib versus diclofenac and omeprazole in reducing the risk of recurrent ulcer bleeding in patients with arthritis[J]. N Engl J Med, 2002;847(347): 2 104- 2 110.
10. Bjordal JM, Ljunggren AE, Klovning A, Slordal L. Non-steroidal anti-inflammatory drugs, including cyclooxygenase-2 inhibitors, in osteoarthritic knee pain: meta-analysis of randomized placebo controlled trials[J]. BMJ, 2004;329(7 478): 1 317.
11. Dieppe P, Bartlett C ,Davey P, Doyal L, Ebrahim S. Balancing benefits and harms: the example of non-steroidal anti-inflammatory drugs[J]. BMJ, 2004;2 562(329): 31-34.

Chinese Journal of Evidence-Based Medicine

Evidence-Based Safety Reassessment of Post Marketed Drug - Importance of Recall of Refecoxib

Abstract Full text Figures/Tables Video References Cited by

Format

Content