Effect of safety issues with HIV drugs on the approval process of other drugs in the same Class: An analysis of European public assessment reports

Drug Safety

Volumn 34, Issue 11, 2011, Pages 1101-1114

  Arnardottir, Arna H ^a   Haaijer Ruskamp, Flora M ^a   Straus, Sabine M J ^b,c   De Graeff, Pieter A ^a,b   Mol, Peter G M ^a,b  

^a UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^b MEDICINES EVALUATION BOARD   (Netherlands)

^c ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

Abacavir; Antiretrovirals; Atazanavir; Clinical trial design; HIV protease inhibitors; Indinavir; Legislation; Lopinavir; Nelfinavir; Nevirapine; Postmarketing surveillance; Regulatory process; Ritonavir; Stavudine; Tenofovir; Tipranavir

Indexed keywords

ABACAVIR; ABACAVIR PLUS LAMIVUDINE; ATAZANAVIR; DIDANOSINE; DIDANOSINE PLUS LAMIVUDINE; HUMAN IMMUNODEFICIENCY VIRUS PROTEINASE INHIBITOR; HYPERICUM PERFORATUM EXTRACT; INDINAVIR; LAMIVUDINE; LOPINAVIR PLUS RITONAVIR; NELFINAVIR; NEVIRAPINE; NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR; OMEPRAZOLE; RNA DIRECTED DNA POLYMERASE INHIBITOR; STAVUDINE; TENOFOVIR; TIPRANAVIR; UNCLASSIFIED DRUG;

ACUTE KIDNEY FAILURE; ARTICLE; BRAIN HEMORRHAGE; CLINICAL ASSESSMENT; DRUG APPROVAL; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG INFORMATION; DRUG SAFETY; GUILLAIN BARRE SYNDROME; HEART INFARCTION; HUMAN; LIVER DYSFUNCTION; MEDICATION ERROR; NEPHROGENIC DIABETES INSIPIDUS; PRIORITY JOURNAL; SIDE EFFECT; SKIN MANIFESTATION;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ANTI-HIV AGENTS; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG TOXICITY; EUROPE; HUMANS; LEGISLATION, DRUG; REFERENCE STANDARDS; RISK FACTORS; TIME FACTORS;

EID: 80053926999     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.2165/11592060-000000000-00000     Document Type: Article

References (63)

1. Schneeweiss S. Developments in post-marketing compara-tive effectiveness research. Clin Pharmacol Ther 2007 Aug; 82 (2): 143-56 (Pubitemid 47075343)
2. Stricker BH, Psaty BM. Detection, verification, and quan-tification of adverse drug reactions. BMJ 2004 Jul 3; 329 (7456): 44-7 (Pubitemid 38870007)
3. Garattini S, Chalmers I. Patients and the public deserve big changes in evaluation of drugs. BMJ 2009 Mar 31; 338: 804-6
4. Reed SD, Califf RM, Schulman KA. How changes in drug-safety regulations affect the way drug and biotech companies invest in innovation. Health Aff (Millwood) 2006 Sep-Oct; 25 (5): 1309-17 (Pubitemid 44497630)
5. Aagaard L, Soendergaard B, Stenver DI, et al. Knowledge creation about ADRs: turning the perspective from the rear mirror to the projector? Br J Clin Pharmacol 2008 Mar; 65 (3): 364-76 (Pubitemid 351316910)
6. Mol PG, Straus SM, Piening S, et al. A decade of safety-related regulatory action in the Netherlands: a retrospective analysis of direct healthcare professional communications from 1999 to 2009. Drug Saf 2010 Jun 1; 33 (6): 463-74
7. Committee for Medicinal Products for Human Use (CHMP). Guideline on the clinical development of medicinal products for the treatment of HIV infection EMEA/CPMP/EWP/633/02 Rev.2 [online]. Available from URL: http://www.ema.europa. eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003460.pdf [Accessed 2010 Jan 12]
8. Epstein RA. The pharmaceutical industry at risk: how ex-cessive government regulation stifles innovation. Clin Pharmacol Ther 2007 Aug; 82 (2): 131-2 (Pubitemid 47075345)
9. Honig P, Lalonde R. The economics of drug development: a grim reality and a role for clinical pharmacology. Clin Pharmacol Ther 2010 Mar; 87 (3): 247-51
10. Struble KA, Chan-Tack KM, Soon GG. Regulatory issues in developing new HIV protease inhibitors: risks and benefits. Curr Opin HIV AIDS 2008 Nov; 3 (6): 676-80
11. Greene WC, Debyser Z, Ikeda Y, et al. Novel targets for HIV therapy. Antiviral Res 2008 Dec; 80 (3): 251-65
12. Hammer SM, Eron Jr JJ, Reiss P, et al. Antiretroviral treatment of adult HIV infection: 2008 recommendations of the International AIDS Society-USA panel. JAMA 2008 Aug 6; 300 (5): 555-70
13. WHO Collaborating Centre for Drug Statistics Methodol-ogy [online]. Available from URL: http://www.whocc.no/atcddd [Accessed 2009 Jan 18]
14. Giezen TJ, Mantel-Teeuwisse AK, Straus SM, et al. Safety-related regulatory actions for biologicals approved in the United States and the European Union. JAMA 2008 Oct 22; 300 (16): 1887-96
15. Dutch Medicines Evaluation Board [online]. Available from URL: www.cbg-meb.nl [Accessed 2009 Jan 6]
16. EMA human medicines [online]. Available from URL: http://www.emea.europa. eu/index/indexh1.htm [Accessed 2009 Jan 29]
17. Committee for Medicinal Products for Human Use (CHMP). Note for guidance on population exposure: the extent of population exposure to assess clinical safety CPMP/ICH/375/95 [online]. Available from URL: http://www.ema. europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500002747. pdf [Accessed 2009 Sep 10]
18. European Medicines Agency. Note for guidance on popula-tion exposure: the extent of population exposure to assess clinical safety (CPMP/ICH/375/95), 1995 [online]. Available from URL: http://www.ema.europa.eu/ema/pages/includes/ document/open-document.jsp?webContentId=WC500002747 [Accessed 2009 Jan 29]
19. European Commission [online]. Available from URL: http://ec.europa.eu/ enterprise/pharmaceuticals/index-en.htm [Accessed 2010 Feb 5]
20. Committee for Medicinal Products for Human Use (CHMP). Guideline on procedures for the granting of a marketing authorisation under exceptional circumstances, pursuant to article 14 (8) of regulation (EC) No 726/2004 (EMEA/357981/2005). 2005 [online]. Available from URL: http://www.ema.europa.eu/ docs/en-GB/document-library/Reg ulatory-and-procedural-guideline/2009/10/ WC500004883. pdf [Accessed 2009 Aug 27]
21. European Commission. Commission regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) no. 726/2004 of the European Parliament and of the Council. 2006 [online]. Available from URL: http://ec.europa.eu/health/files/eu dralex/vol-1/reg-2006-507/reg-2006-507-en. pdf [Accessed 2009 Sep 27]
22. Thomson Reuters [online]. Available from URL: http://thomsonreuters.com [Accessed Jan 20]
23. Grubb P. Protecting the assets: patenting and intellectual property. In: Rang HP, editor. Drug discovery and development, technology in transition. London: Churchill Livingstone, 2006: 273-80
24. Plosker GL, Noble S. Indinavir: a review of its use in the man-agement of HIV infection. Drugs 1999 Dec; 58 (6): 1165-203 (Pubitemid 30055050)
25. European Medicines Agency. Agenerase: summary of pro-duct characteristics, 2000 [online]. Available from URL: http://ec.europa.eu/health/ documents/community-register/2000/200010203852/anx-3852-en.pdf [Accessed 2010 Jan]
26. European Medicines Agency. Kaletra: summary of product characteristics, 2001 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/2001/200103204167/anx-4167-en.pdf [Accessed 2010 Jan]
27. European Medicines Agency. Reyataz: summary of product characteristics, 2004 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/2004/200403027570/anx-7570-en.pdf [Accessed 2009 Jan]
28. European Medicines Agency. Telzir: summary of product characteristics, 2004 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/2004/200407127969/anx-7969-en.pdf [Accessed 2010 Jan]
29. European Medicines Agency. Aptivus: summary of product characteristics, 2005 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/2005/2005102510127/anx-10127-en.pdf [Accessed 2010 Jan]
30. European Medicines Agency. Prezista: summary of product characteristics, 2007 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/2007/2007021219209/anx-19209-en.pdf [Accessed 2010 Jan]
31. European Medicines Agency. Norvir: summary of product characteristics, 1996 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/1996/199608263040/anx-3040-en.pdf [Accessed 2010 Jan]
32. European Medicines Agency. Viracept: summary of product characteristics, 1998 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/1998/199801223163/anx-3163-en.pdf [Accessed 2010 Jan]
33. European Medicines Agency. Invirase: summary of product characteristics, 1996 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/1996/199610043314/anx-3314-en.pdf [Accessed 2010 Jan]
34. D:A:D Study Group, Sabin CA, Worm SW, et al. Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients enrolled in the D:A:D study: a multi-cohort collaboration. Lancet 2008 Apr 26; 371 (9622): 1417-26
35. European Medicines Agency. Norvir: summary of product characteristics, 2010 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/2010/20100110392008/anx-92008-en.pdf [Accessed 2011 Jan]
36. European Medicines Agency. Viracept: summary of product characteristics, 2010 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/2010/2010012073128/anx-73128-en.pdf [Accessed 2011 Jan]
37. European Medicines Agency. Invirase: summary of product characteristics, 2010 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/2010/2010072883894/anx-83894-en.pdf [Accessed 2011 Jan]
38. European Medicines Agency. Crixivan: summary of product characteristics, 1996 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/1996/199610043052/anx-3052-en.pdf [Accessed 2010 Jan]
39. European Medicines Agency. Agenerase: summary of pro-duct characteristics, 2009 [online]. Available from URL: http://ec.europa.eu/health/ documents/community-register/2009/2009122171951/anx-71951-en.pdf [Accessed 2011 Jan]
40. European Medicines Agency. Kaletra: summary of product characteristics, 2010 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/2010/2010121394669/anx-94669-en.pdf [Accessed 2011 Jan]
41. European Medicines Agency. Telzir: summary of product characteristics, 2010 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/2010/2010082686289/anx-86289-en.pdf [Accessed 2011 Jan]
42. European Medicines Agency. Crixivan: summary of product characteristics, 2010 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/2010/2010080684649/anx-84649-en.pdf [Accessed 2011 Jan]
43. European Medicines Agency. Reyataz: summary of product characteristics, 2010 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/2010/2010070582656/anx-82656-en.pdf [Accessed 2011 Jan]
44. European Medicines Agency. Viread: summary of product characteristics, 2002 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/2002/200202054861/anx-4861-en.pdf [Accessed 2009 Jan]
45. European Medicines Agency. Emtriva: summary of product characteristics, 2003 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/2003/200310247078/anx-7078-en.pdf [Accessed 2010 Jan]
46. European Medicines Agency. Epivir: summary of product characteristics, 1996 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/1996/199608084840/anx-4840-en.pdf [Accessed 2009 Jan]
47. European Medicines Agency. Ziagen: patient information leaflet, 2000 [online]. Available from URL: http://ec.eur opa.eu/health/documents/community- register/2000/2000021 53492/anx-3492-en.pdf [Accessed 2010 Jan]
48. European Medicines Agency. Epivir: summary of product characteristics, 2010 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/2010/2010102591188/anx-91188-en.pdf [Accessed 2011 Jan]
49. European Medicines Agency. Ziagen: summary of product characteristics, 2010 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/2010/2010051079633/anx-79633-en.pdf [Accessed 2011 Jan]
50. European Medicines Agency. Zerit: summary of product characteristics, 1996 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/1996/199605082960/anx-2960-en.pdf [Accessed 2010 Jan]
51. European Medicines Agency. Zerit: summary of product characteristics, 2010 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/2010/2010120393869/anx-93869-en.pdf [Accessed 2011 Jan]
52. European Medicines Agency. Intelence: summary of pro-duct characteristics, 2009 [online]. Available from URL: http://ec.europa.eu/health/ documents/community-register/2009/2009042358548/anx-58548-en.pdf [Accessed 2010 Jan]
53. European Medicines Agency. Sustiva: summary of product characteristics, 1999 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/1999/199905283323/anx-3323-en.pdf [Accessed 2010 Jan]
54. European Medicines Agency. Sustiva: summary of product characteristics, 2010 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/2010/2010110391890/anx-91890-en.pdf [Accessed 2011 Jan]
55. European Medicines Agency. Viread: summary of product characteristics, 2010 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/2010/2010090686009/anx-86009-en.pdf [Accessed 2011 Jan]
56. European Medicines Agency. Emtriva: summary of product characteristics, 2010 [online]. Available from URL: http://ec.europa.eu/health/documents/ community-register/2010/2010082687328/anx-87328-en.pdf [Accessed 2011 Jan]
57. European Medicines Agency. Aptivus: summary of product characteristics [online]. Available from URL: http://www. ema.europa.eu/docs/en-GB/document- library/EPAR-Product-Information/human/000631/WC500025936.pdf [Accessed 2009 Jan 29]
58. Falcon RW, Kakuda TN. Drug interactions between HIV protease inhibitors and acid-reducing agents. Clin Phar-macokinet 2008; 47 (2): 75-89
59. CMR International 2010 Pharmaceutical R&D Factbook. London: CMR International, a Thomson Reuters business, 2010
60. Lasser KE, Allen PD, Woolhandler SJ, et al. Timing of new black box warnings and withdrawals for prescription medications. JAMA 2002 May 1; 287 (17): 2215-20 (Pubitemid 34441937)
61. Struble KA, Reynolds KS. A regulatory perspective on the role of drug interactions in antiretroviral drug development. Curr Opin HIV AIDS 2008 May; 3 (3): 325-9 (Pubitemid 351521018)
62. Dunne M. Antiretroviral drug development: the challenge of cost and access. AIDS 2007 Jul; 21 Suppl. 4: S73-9 (Pubitemid 47051752)
63. Arnardottir AH, Haaijer-Ruskamp FM, Straus SM, et al. Additional safety risk to exceptionally approved drugs in Europe? Br J Clin Pharmacol 2011 Sep; 72 (3): 490-9