Open-label extension studies: Do they provide meaningful information on the safety of new drugs?

Drug Safety

Volumn 30, Issue 2, 2007, Pages 93-105

  Day, Richard O ^a   Williams, Kenneth M ^a  

^a ST VINCENT S HOSPITAL   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

CERIVASTATIN; CYCLOOXYGENASE 2 INHIBITOR; HALOPERIDOL; NAPROXEN; NONSTEROID ANTIINFLAMMATORY AGENT; OLANZAPINE; PLACEBO; ROFECOXIB; ROSUVASTATIN; STATIN;

CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DRUG EFFICACY; DRUG MARKETING; DRUG RESEARCH; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL SYMPTOM; HEALTH MAINTENANCE ORGANIZATION; HUMAN; MEDICAL INFORMATION; POSTMARKETING SURVEILLANCE; PRESCRIPTION; PRIORITY JOURNAL; PROFESSIONAL PRACTICE; REVIEW; RHEUMATOID ARTHRITIS; RISK FACTOR; SCHIZOPHRENIA; THROMBOSIS;

ADVERTISING; CLINICAL TRIALS; DRUG APPROVAL; DRUGS, INVESTIGATIONAL; ETHICS, CLINICAL; ETHICS, RESEARCH; GUIDELINES; HEALTH SERVICES ACCESSIBILITY; HUMANS; MARKETING OF HEALTH SERVICES; RESEARCH DESIGN;

EID: 33846661265     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200730020-00001     Document Type: Review

References (25)

1. Schneider LS. Open label extension studies and misinformation [letter]. Arch Neurol 2006; 63: 1036
2. Taylor WJ, Weatherall M. What are open-label extension studies for? J Rheumatol 2006; 33 (4): 642-3
3. Bathon JM, Martin RW, Fleischmann RM, et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med 2000; 343 (22): 1586-93
4. Taylor GJ, Wainwright P. Open label extension studies: research or marketing? BMJ 2005; 331: 572-4
5. Adverse drug reactions. BMJ 1989; 282: 1819-20
6. Inman WHW. Editor's introduction and commentary. In: Inman WHW, editor. Monitoring for drug safety. 2nd ed. Lancaster: Springer, 1986: 4
7. Fung M, Thornton A, Mybeck K, et al. Evaluation of the characteristics of safety withdrawal of prescription drugs from worldwide pharmaceutical markets: 1960 to 1999. Drug Inf J 2001; 35: 293-317
8. Johnsen SP, Larsson H, Tarone RE, et al. Risk of hospitalization for myocardial infarction among users of rofecoxib, celecoxib, and other NSAIDs: a population-based case-control study. Arch Intern Med 2005; 165: 978-84
9. de Klerk E, van der Heijde D, Landewe R, et al. Patient compliance in rheumatoid arthritis, polymyalgia and gout. J Rhematology 2003; 30 (1): 44-54
10. Bombardier C, Laine 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 (21): 1520-30
11. FitzGerald GA. Coxibs and cardiovascular disease. N Engl J Med 2004; 351 (17): 1709-10
12. Bresalier RS, Sandler RS, Quan H, et al. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 2005; 352 (11): 1092-102
13. Ray WA, Stein M, Daugherty JR, et al. Cox-2 selective non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease. Lancet 2002; 360: 1072-3
14. Schnitzer TJ, Truitt K, Fleishmann R, et al. The safety profile, tolerability, and effective dose range of rofecoxib in the treatment of rheumatoid arthritis. Clin Ther 1999; 21 (10): 1688-702
15. Ehrich EW, Schnitzer TJ, McIlwain H, et al. Effect of specific COX-2 inhibition in osteoarthritis of the knee: a 6 week double blind, placebo controlled pilot study of rofecoxib. J Rheumatol 1999; 26 (11): 2438-47
16. Reicin AS, Shapiro D, Sperling RS, et al. Comparison of cardiovascular thrombotic events in patients with osteoarthritis treated with rofecoxib versus nonselective nonsteroidal anti-inflammatory drugs (ibuprofen, diclofenac, and nabumetone) [comment]. Am J Cardiol 2002; 89 (2): 204-9
17. US Food and Drug Administration. Guidance for industry. Premarketing risk assessment. In: Services USDoHaH, Administration FaD, (CDER) CfDEaR, (CBER) CfBEaR, editors. Office of Training and Communication, Division of Drug Information, HFD-240, Center for Drug Evaluation and Research, Food and Drug 2005 [online]. Available from URL: http://www.fda.gov/cder/guidance/6357fnl.htm [Accessed 2006 Dec 27]
18. Silman A, Symmons D. Reporting requirements for longitudinal observational studies in rheumatology. J Rhematol 1999; 26: 481-3
19. Wolfe F, Hassere M, van der Heijde D, et al. Preliminary core set of domains and reporting requirements for longitudinal observation studies in rheumatology. J Rheumatol 1999; 26: 484-9
20. Donofrio PD, Raskin P, Rosenthal NR, et al. Safety and effectiveness of topiramate for the management of painful diabetic peripheral neuropathy in an open-label extension study. Clinical Ther 2005; 27 (9): 1420-31
21. Davidson MH. Rosuvastatin safety: lessons from the FDA review and post-approval surveillance. Expert Opin Drug Saf 2004; 3 (6): 547-57
22. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. General Considerations for Clinical Trials E8. 17 July 1997. Available from URL: http://www.ich.org/LOB/media/MEDIA484.pdf [Accessed 2007 Jan 3]
23. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice E6(RI). 10 June 1996. Available from URL: http://www.ich.org/LOB/media/Media482.pdf [Accessed 2007 Jan 3]
24. De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med 2004; 351 (12): 1250-1
25. Ray WA, Stein CM. Reform of drug regulation: beyond an independent drug-safety board. N Engl J Med 2006; 354 (2): 194-201