Incidence of spontaneous notifications of adverse reactions with aceclofenac, meloxicam, and rofecoxib during the first year after marketing in the United Kingdom

Therapeutics and Clinical Risk Management

Volumn 3, Issue 2, 2007, Pages 225-230

  Raber, Anna ^a   Heras, Joan ^a   Costa, Joan ^b   Fortea, Josep ^a   Cobos, Albert ^c  

^a Almirall Prodesfarma S A   (Spain)

^b HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL   (Spain)

^c UNIVERSITY OF BARCELONA   (Spain)

Author keywords

Aceclofenac; Adverse reactions; Meloxicam; Nonsteroidal anti inflammatory drugs; Pharmacovigilance; Post marketing; Rofecoxib

Indexed keywords

ACECLOFENAC; CYCLOOXYGENASE 2; CYCLOOXYGENASE 2 INHIBITOR; MELOXICAM; NONSTEROID ANTIINFLAMMATORY AGENT; ROFECOXIB;

ABDOMINAL PAIN; ARTICLE; CONFIDENCE INTERVAL; DATA BASE; DRUG MARKETING; DRUG MONITORING; DRUG SELECTIVITY; DRUG SURVEILLANCE PROGRAM; EDEMA; GASTROINTESTINAL HEMORRHAGE; HUMAN; HYPERTENSION; INCIDENCE; LIVER TOXICITY; THROMBOEMBOLISM; UNITED KINGDOM; WORLD HEALTH ORGANIZATION;

EID: 34250014122     PISSN: 11766336     EISSN: None     Source Type: Journal    
DOI: 10.2147/tcrm.2007.3.2.225     Document Type: Article

References (31)

1. Altman DG, Machin D, Bryant TN, et al (eds). 2000. Statistics with Confidence. Bristol: BMJ Bks.
2. Bombardier C, Laine L, Reicin A, et al. 2000. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med, 343:1520-8.
3. Caulin C. 2002. From the chemical product to the authorization of drug marketing. Rev Prat, 52:486-90.
4. Hrachavec JB, Mora M. 2001. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. Author reply. JAMA, 286:2399-400.
5. Laporte JR, Ibanez L, Vidal X, et al. 2004. Upper gastrointestinal bleeding associated with the use of NSAIDs: newer versus older agents. Drug Saf, 27:411-20.
6. Layton O, Heeley E, Hugues K, et al. 2003. Comparison of the incidence rates of selected gastrointestinal events reported for patients prescribed rofecoxib and meloxicam in general practice in England using prescription-event monitoring data. Rheumatology, 42:622-31.
7. MacDonald TM, Morant SV, Goldstein JL, et al. 2003. Channelling bias and the incidence of gastrointestinal haemorrhage in users of meloxicam, coxibs, and older, non-specific non-steroidal anti-inflammatory drugs. Gut, 52:1265-70.
8. Malhotra S, Pandhi P, Shafiq N. 2004. COX-2 inhibitors: a CLASS act or Just VIGORously promoted. Med Gen Med, 6:6.
9. Merck & Co. 2004. Merck anuncia la retirada voluntaria de la venta de VIOXX® en todo el mundo [online]. Accessed on 3 October 2004. URL: http://www.vioxx.com/vioxx/documents/spanish/vioxx_press_release.pdf.
10. Moride Y, Ducruet T, Boivin JF, et al. 2005. Prescription channeling of COX-2 inhibitors and traditional nonselective nonsteroidal anti-inflammatory drugs: a population-based case-control study. Arthritis Res Ther, 7:R333-42.
11. Mukherjee D, Nissen SE, Topol EJ. 2001. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA, 286:954-9.
12. Ofman JJ, Badamgaray E, Henning JM, et al. 2004. Utilization of nonsteroidal anti-inflammatory drugs and antisecretory agents: a managed care claims analysis. Am J Med, 116:835-42.
13. Okie S. 2005. Raising the safety bar - the FDA's coxib meeting. N Eng J Med, 352:13.
14. Pedros C, Cerecza G, Laporte JR. 2002. Primeras notificaciones espontáneas de sospechas de reacciones adversas a los nuevos antiinflamatorios selectivos sobre la ciclooxigenasa-2. Med Clin, 118:415-17.
15. Peloso PM. 1996. Strategies and practice for use of nonsteroidal anti-inflammatory drugs. Scand J Rheumatol, 105(Suppl):29-43.
16. Rawson NS, Nourjah F, Grosser SC, et al. 2005. Factors associated with celecoxib and rofecoxib utilization. Ann Pharmacother, 39:597-602.
17. Sahai H, Khurshid A. 1996. Statistics in epidemiology, methods, techniques and applications. Boca Raton: CRC Pr.
18. Seibert K, Masferrer J, Zhang Y, et al. 1995. Mediation of inflammation by cyclooxygenase-2. Agents Actions, 46(Suppl):41-50.
19. Silverstein FE, Faich G, Goldstein JL, et al. 2000. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. Celecoxib Long-term Arthritis Safety Study. JAMA, 284:1247-55.
20. Simon LS. 1995. Actions and toxicity of nonsteroidal anti-inflammatory drugs. Curr Opin Rheumatol, 7:159-66.
21. Singh G, Rosen Ramey DR. 1998. NSAID reduced gastrointestinal complications: the ARAMIS perspective - 1997. Arthritis, Rheumatism and Aging Medical Information System. J Rheumatol, 51 (Suppl):8-16.
22. Tramer MR, Moore RA, Reynolds DJ, et al. 2000. Quantitative estimation of rare adverse events which follow a biological progression: a new model applied to chronic NSAID use. Pain, 85:169-82.
23. [UK MCA] Medicines and Healthcare products Regulatory Agency. 2004. Monitoring the safety and quality of medicines: Pharmacovigilance [online]. Accessed on 11 August 2004. URL: http://www.mhra.gov.uk.
24. Vane JR, Botting RM. 1998. Mechanism of action of nonsteroidal anti-inflammatory drugs. Am J Med, 104:2S-8S.
25. Vane JR. 1971. Inhibition of prostaglandin synthesis as a mechanism of action for aspirin-like drugs. Nature, 231:232-5.
26. [WHO] Norwegian Institute of Public Health. 2004. World Health Organisation Collaborating Centre for Drug Statistics Methodology [online]. Accessed on 3 October 2004. URL: http://www.whocc.no/atcddd.
27. Wolfe F, Anderson J, Burke TA, et al. 2002. Gastroprotective therapy and risk of gastrointestinal ulcers: risk reduction by COX-2 therapy. J Rheumatol, 29:467-73.
28. Wolfe F, Flowers N, Burke TA, et al. 2002. Increase in lifetime adverse drug reactions, service utilization, and disease severity among patients who will start COX-2 specific inhibitors: quantitative assessment of channeling bias and confounding by indication in 6689 patients with rheumatoid arthritis and osteoarthritis. J Rheumatol, 29:1015-22.
29. Wolfe MM, Lichtenstein DR, Singh G. 1999. Gastrointestinal toxicity of nonsteroidal anti-inflammatory drugs. N Engl J Med, 340:1888-99.
30. Wright JM, Perry TL, Bassett KL, et al. 2001. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA, 286:2398-400.
31. Zhao SZ, Burke TA, Whelton A, et al. 2002. Comparison of the baseline cardiovascular risk profile among hypertensive patients prescribed COX-2-specific inhibitors or nonspecific NSAIDs: data from real-life practice. Am J Manag Care, 8(15 Suppl):S392-400.