The rosiglitazone decision process at FDA and EMA. What should we learn?

International Journal of Risk and Safety in Medicine

Volumn 24, Issue 2, 2012, Pages 73-80

  Pouwels, Koen B ^a   Van Grootheest, Kees ^a,b  

^a UNIVERSITY OF GRONINGEN   (Netherlands)

^b Netherlands Pharmacovigilance Centre Lareb   (Netherlands)

Author keywords

decisions; EMA; FDA; myocardial ischemia; Rosiglitazone

Indexed keywords

INSULIN; ROSIGLITAZONE;

ARTICLE; CARDIOVASCULAR RISK; DECISION MAKING; DRUG APPROVAL; DRUG MARKETING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEART FAILURE; HUMAN; ISCHEMIC HEART DISEASE;

DIABETES MELLITUS, TYPE 2; DRUG APPROVAL; DRUG SYNERGISM; DRUG THERAPY, COMBINATION; EUROPE; EUROPEAN UNION; GUIDELINES AS TOPIC; HEART FAILURE; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; META-ANALYSIS AS TOPIC; MYOCARDIAL ISCHEMIA; RISK ASSESSMENT; SAFETY-BASED DRUG WITHDRAWALS; THIAZOLIDINEDIONES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84863702943     PISSN: 09246479     EISSN: 18786847     Source Type: Journal    
DOI: 10.3233/JRS-2012-0559     Document Type: Article

References (51)

1. E. Blind, K. Dunder, P.A. de Graeff and E. Abadie, Rosiglitazone: A European regulatory perspective, Diabetologia 54(2) (2011), 213-218.
2. S.E. Nissen, The rise and fall of rosiglitazone, Eur Heart J 31(7) (2010), 773-776.
3. D. Cohen, Rosiglitazone: What went wrong? BMJ 6(341) (2010), c4848.
4. European Medicines Agency. European Medicines Agency recommends suspension of Avandia, Avandmet and Avaglim. Press release. 2010; Available at: http://www.ema.europa.eu/docs/en GB/document library/Press release/2010/09/ WC500096996.pdf. Accessed June 27, 2011.
5. J. Woodcock, J.M. Sharfstein and M. Hamburg, Regulatory action on rosiglitazone by the U.S. Food and Drug Administration, N Engl J Med 363(16) (2010), 1489-1491.
6. European Medicines Agency. Avandia: EPAR - Scientific Discussion. 2011; Available at: http://www.ema.europa.eu/ docs/en GB/document library/EPAR - Scientific Discussion/human/000268/WC500029103.pdf. Accessed July 25, 2011.
7. European Medicines Agency. Avandia-H-C-268-A20-75: EPAR - Assessment Report. 2011; Available at: http://www. ema.europa.eu/docs/en GB/document library/EPAR - Assessment Report - Variation/human/000268/WC500100757.pdf. Accessed June 28, 2011.
8. U.S. Food and Drug Administration. Label approved on 05/25/1999 for Avandia. 1999; Available at: http://www. accessdata.fda.gov/drugsatfda docs/label/1999/21071lbl.pdf. Accessed June 27, 2011.
9. U.S. Food and Drug Administration. Label approved on 04/03/2000 for Avandia. 2000; Available at: http://www. accessdata.fda.gov/drugsatfda docs/nda/2000/21-071S001 Avandia prntlbl.pdf. Accessed June 27, 2011.
10. U.S. Food and Drug Administration. Approval package for Avandia (NDA 21-071/S-004). 2003; Available at: http://www.accessdata.fda.gov/drugsatfda docs/nda/2003/021071 S004 AVANDIA.pdf. Accessed July 25, 2011.
11. U.S. Food and Drug Administration. Briefing document. Division of Metabolism and Endocrine Products and Office of Surveillance and Epidemiology. Joint meetin of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee 2007; Available at: http://www.fda.gov/ ohrms/dockets/ac/07/briefing/2007-4308b1-02-fda- backgrounder.pdf. Accessed June 29, 2011.
12. U.S. Food and Drug Administration. Label approved on 04/23/2007 for Avandia. 2007; Available at: http://www. accessdata.fda.gov/drugsatfda docs/label/2007/021071s023lbl.pdf. Accessed June 27, 2011.
13. European Medicines Agency. Avandia: EPAR - Procedural steps taken and scientific information after authorisation. 2011; Available at: http://www.ema.europa.eu/docs/en GB/document library/EPAR - Procedural steps taken and scientific information after authorisation/human/000268/WC500029110. pdf. Accessed July 25, 2011.
14. D.M. Nathan, Rosiglitazone and cardiotoxicity-weighing the evidence, N Engl J Med 357(1) (2007), 64-66.
15. B.M. Psaty and C.D. Furberg, The record on rosiglitazone and the risk of myocardial infarction, N Engl J Med 357(1) (2007), 67-69.
16. E.A. Gale, Therapy: The second time as farce: Rosiglitazone and the regulators, Nat Rev Endocrinol 7(1) (2011), 5-6.
17. U.S. Food and Drug Administration. Jenkins JK. Recommendations for regulatory actions - rosiglitazone. 2010; Available at; http://www.fda.gov/ downloads/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ UCM226236.pdf. Accessed July 27, 2011.
18. S.E. Nissen and K. Wolski, Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes, N Engl J Med 356(24) (2007), 2457-2471.
19. P.D. Home, S.J. Pocock, H. Beck-Nielsen, R. Gomis, M. Hanefeld and N.P. Jones, et al., Rosiglitazone evaluated for cardiovascular outcomes-an interim analysis, N Engl J Med 357(1) (2007), 28-38.
20. U.S. Food and Drug Administration. GlaxoSmithKline Core Presentations, AVANDIA (rosiglitazone maleate) Tablets, for the July 13-14, 2010 Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. 2010; Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ Drugs/EndocrinologicandMetabolic DrugsAdvisoryCommittee/UCM218500.pdf. Accessed July 27, 2011.
21. S.E. Kahn, S.M. Haffner, M.A. Heise, W.H. Herman, R.R. Holman and N.P. Jones, et al., Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy, N Engl J Med 355(23) (2006), 2427-2443.
22. DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) Trial Investigators, H.C. Gerstein, S. Yusuf, J. Bosch, J. Pogue and P. Sheridan, et al., Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: A randomised controlled trial, Lancet 368(9541) (2006), 1096-1105.
23. C.B. Johannes, C.E. Koro, S.G. Quinn, J.A. Cutone and J.D. Seeger, The risk of coronary heart disease in type 2 diabetic patients exposed to thiazolidinediones compared to metformin and sulfonylurea therapy, Pharmacoepidemiol Drug Saf 16(5) (2007), 504-512.
24. A.T. McAfee, C. Koro, J. Landon, N. Ziyadeh and A.M. Walker, Coronary heart disease outcomes in patients receiving antidiabetic agents, Pharmacoepidemiol Drug Saf 16(7) (2007), 711-725.
25. Cardiac Safety Research Consortium. Kaul S. How to leverage large databases for prospective and retrospective safety and benefit analyses: Is a CV safety warehouse feasible? 2011; Available at: https://www.cardiac-safety.org/ thinktanks/ presentations-4-13-11/%232-%20Kaul.pdf. Accessed June 25, 2011.
26. European Medicines Agency. Avandia-H-C-268-II-52: EPAR - Scientific Discussion - Variation. 2011; Available at: http://www.ema.europa.eu/docs/en GB/document library/EPAR - Scientific Discussion - Variation/human/000268/ WC500029107.pdf. Accessed June 25, 2011.
27. U.S. Food and Drug Administration. Parks MH, M.D., Director, Division of Metabolism and Endocrinology Products (DMEP). 2010; Available at: http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/ Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM218482.pdf. Accessed June 25, 2011.
28. U.S. Food and Drug Administration. Dal Pan GJ. RE: Recommendations for Regulatory Action for Rosiglitazone and Rosiglitazone containing Products (NDA 21-071, supplement 035, incoming submission dated August 25, 2009). 2010; Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/UCM226240.pdf. Accessed June 25, 2011.
29. P.D. Home, S.J. Pocock, H. Beck-Nielsen, P.S. Curtis, R. Gomis, M. Hanefeld, et al., Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): A multicentre, randomised, open-label trial, Lancet 373(9681) (2009 Jun 20), 2125-2135.
30. D.J. Graham, R. Ouellet-Hellstrom, T.E. MaCurdy, F. Ali, C. Sholley, C.Worrall, et al., Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone, JAMA 304(4) (2010), 411-418.
31. S.E. Nissen and K. Wolski, Rosiglitazone revisited: An updated meta-analysis of risk for myocardial infarction and cardiovascular mortality, Arch Intern Med 170(14) (2010), 1191-1201.
32. U.S. Food and Drug Administration. Woodcock J. Decision on continued marketing of rosiglitazone (Avandia, Avandamet, Avandaryl). 2010; Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/UCM226959.pdf. Accessed June 26, 2011.
33. L.L. Lipscombe, T. Gomes, L.E. Levesque, J.E. Hux, D.N. Juurlink and D.A. Alter, Thiazolidinediones and cardiovascular outcomes in older patients with diabetes, JAMA 298(22) (2007), 2634-2643.
34. K.M. Stockl, L. Le, S. Zhang and A.S. Harada, Risk of acute myocardial infarction in patients treated with thiazolidinediones or other antidiabetic medications, Pharmacoepidemiol Drug Saf 18(2) (2009), 166-174.
35. I. Tzoulaki, M. Molokhia, V. Curcin, M.P. Little, C.J. Millett, A. Ng, et al., Risk of cardiovascular disease and all cause mortality among patients with type 2 diabetes prescribed oral antidiabetes drugs: Retrospective cohort study using UK general practice research database, BMJ 339 (2009), b4731.
36. N. Ziyadeh, A.T. McAfee, C. Koro, J. Landon and K. Arnold Chan, The thiazolidinediones rosiglitazone and pioglitazone and the risk of coronary heart disease: A retrospective cohort study using a US health insurance database, Clin Ther 31(11) (2009), 2665-2677.
37. D.N. Juurlink, T. Gomes, L.L. Lipscombe, P.C. Austin, J.E. Hux and M.M. Mamdani, Adverse cardiovascular events during treatment with pioglitazone and rosiglitazone: population based cohort study, BMJ 339 (2009), b2942.
38. W.C.Winkelmayer, S. Setoguchi, R. Levin and D.H. Solomon, Comparison of cardiovascular outcomes in elderly patients with diabetes who initiated rosiglitazone vs. pioglitazone therapy, Arch Intern Med 168(21) (2008), 2368-2375.
39. A.M. Walker, C.E. Koro and J. Landon, Coronary heart disease outcomes in patients receiving antidiabetic agents in the PharMetrics database 2000-2007, Pharmacoepidemiol Drug Saf 17(8) 760-768.
40. C.M. Gerrits, M. Bhattacharya, S. Manthena, R. Baran, A. Perez and S. Kupfer, A comparison of pioglitazone and rosiglitazone for hospitalization for acute myocardial infarction in type 2 diabetes, Pharmacoepidemiol Drug Saf 16(10) (2007), 1065-1071.
41. C.R. Dormuth, M. Maclure, G. Carney, S. Schneeweiss, K. Bassett and J.M. Wright, Rosiglitazone and myocardial infarction in patients previously prescribed metformin, PLoS One 4(6) (2009), e6080.
42. J.S. Brownstein, S.N. Murphy, A.B. Goldfine, R.W. Grant, M. Sordo, V. Gainer, et al., Rapid identification of myocardial infarction risk associated with diabetes medications using electronic medical records, Diabetes Care 33(3) (2010), 526-531.
43. C.E. Koro, Q. Fu and M. Stender, An assessment of the effect of thiazolidinedione exposure on the risk of myocardial infarction in type 2 diabetic patients, Pharmacoepidemiol Drug Saf 17(10) (2008), 989-996.
44. U.S. Food and Drug Admininstration. McEvoy B, Dr.P.H., Office of Biostatistics, Office of Translational Sciences, CDER, FDA. 2010; Available at: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM224739.pdf. Accessed July 26, 2011.
45. U.S. Food and Drug Admininstration. Gelperin K, M.D., Medical Officer, Division of Epidemiology, Office of Surveillance and Epidemiology. 2010; Available at: http://www.fda.gov/downloads/AdvisoryCommittees/Committees MeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ UCM224730.pdf. Accessed July 26, 2011.
46. European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. THIN database study on rosiglitazone use. 2010; Available at: http://www.encepp.eu/encepp/viewResource.htm?id=1592. Accessed May 25, 2011.
47. A.J. Krentz, Rosiglitazone: Trials, tribulations and termination, Drugs 71(2) (2011 Jan 22), 123-130.
48. U.S. Food and Drug Administration. Guidance for Industry. Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. 2008; Available at: www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm071627.pdf. Accessed May 24, 2011.
49. U.S. Food and Drug Administration. Guidance for Industry. Diabetes Mellitus:Developing Drugs and Therapeutic Biologics for Treatment and Prevention - draft. 2008;. Accessed May 25, 2011.
50. European Medicines Agency. Guideline on clincial investigation of medicinal products in the treatment of diabetes mellitus - draft. 2010; Available at: http://www.ema.europa.eu/docs/en GB/document library/Scientific guideline/2010/02/WC500073570.pdf. Accessed May 24, 2011.
51. S. Garattini and V. Bertele', Rosiglitazone and the need for a new drug safety agency, BMJ 341 (2010), c5506.