Delays in the post-marketing withdrawal of drugs to which deaths have been attributed: A systematic investigation and analysis

BMC Medicine

Volumn 13, Issue 1, 2015, Pages

  Onakpoya, Igho J ^a   Heneghan, Carl J ^a   Aronson, Jeffrey K ^a  

^a UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

Death; Drug withdrawal; Review; Voluntary recall

Indexed keywords

ADVERSE DRUG REACTION; AFRICA; ARTICLE; AUTHORITY; BOOK; CARDIOTOXICITY; CLINICAL TRIAL (TOPIC); DATA BASE; DEATH; DRUG FATALITY; DRUG MANUFACTURE; DRUG MARKETING; DRUG RECALL; DRUG SAFETY; EUROPEAN; HUMAN; LIVER TOXICITY; MEDLINE; MORTALITY; POSTMARKETING SURVEILLANCE; PUBLICATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESPIRATION DEPRESSION; SYSTEMATIC REVIEW; WORLD HEALTH ORGANIZATION; EUROPE; STATISTICS AND NUMERICAL DATA;

DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EUROPE; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; SAFETY-BASED DRUG WITHDRAWALS;

EID: 84924082630     PISSN: None     EISSN: 17417015     Source Type: Journal    
DOI: 10.1186/s12916-014-0262-7     Document Type: Article

References (57)

1. Edwards R, Wiholm BE, Martinez C. Concepts in risk-benefit assessment. A simple merit analysis of a medicine? Drug Saf. 1996;15:1-7.
2. Raine J, Wise L, Talbot J, Aronson JK. Proactive pharmacovigilance and risk management. In: Talbot J, Aronson JK, editors. Stephens' Detection and Evaluation of Adverse Drug Reactions: Principles and Practice. 6th ed. Oxford: Wiley-Blackwell; 2011. p. 389-409.
3. Greener M. Drug safety on trial. Last year's withdrawal of the anti-arthritis drug Vioxx triggered a debate about how to better monitor drug safety even after approval. EMBO Rep. 2005;6:202-4.
4. European Commission. A Guideline on Summary of Product Characteristics (SmPC). September 2009. http://ec.europa.eu/health/files/eudralex/vol-2/c/smpc_guideline_rev2_en.pdf. [Accessed 20th March, 2014].
5. Aronson JK. Drug withdrawals because of adverse effects. In: Side Effects of Drugs Annual 30, vol. 30. Amsterdam: Elsevier; 2008. p. xxxi-v.
6. Talbot J, Waller P, editors. Stephens' Detection of New Adverse Drug Reactions. 5th ed. Chichester: John Wiley and Sons Ltd; 2004.
7. WHO Collaborating Centre for Drug Statistics Methodology. Complete ATC/DDD Index 2008. http://www.whocc.no/atcddd. [Accessed 21 Apr 2013].
8. OCEBM Levels of Evidence Working Group. The Oxford 2011 Levels of Evidence. Oxford Centre for Evidence-Based Medicine. http://www.cebm.net/index.aspx?o=5653.
9. Chilcote RR, Williams B, Wolff LJ, Baehner RL. Sudden death in an infant from methemoglobinemia after administration of "sweet spirits of nitre". Pediatrics. 1977;59:280-2.
10. Wright HN. Fatal phenobarbital poisoning. report of a case with toxicologic analysis. Arch Intern Med (Chic). 1929;43:85-9.
11. Aronson JK, Price D, Ferner RE. A strategy for regulatory action when new adverse effects of a licensed product emerge. Drug Saf. 2009;32:91-8.
12. Wingspread Conference on the Precautionary Principle. 26 January 1998. http://www.sehn.org/wing.html. [Accessed 17th November, 2014].
13. Clarke A, Deeks JJ, Shakir SA. An assessment of the publicly disseminated evidence of safety used in decisions to withdraw medicinal products from the UK and US markets. Drug Saf. 2006;29:175-81.
14. McNaughton R, Huet G, Shakir S. An investigation into drug products withdrawn from the EU market between 2002 and 2011 for safety reasons and the evidence used to support the decision-making. BMJ Open. 2014;4:e004221.
15. Arnaiz JA, Carné X, Riba N, Codina C, Ribas J, Trilla A. The use of evidence in pharmacovigilance. Case reports as the reference source for drug withdrawals. Eur J Clin Pharmacol. 2001;57:89-91.
16. Aronson JK, Loke Y, Derry S. Adverse drug reactions: keeping up to date. Fundam Clin Pharmacol. 2002;16:49-56.
17. Loke YK, Derry S, Price D, Aronson JK. Case reports of suspected adverse drug reactions-systematic literature survey of follow-up. BMJ. 2006;332:335-9.
18. Romain N, Giroud C, Michaud K, Mangin P. Suicide by injection of a veterinarian barbiturate euthanasia agent: report of a case and toxicological analysis. Forensic Sci Int. 2003;131:103-7.
19. Beasley R, Pearce N, Crane J, Burgess C. Withdrawal of fenoterol and the end of the New Zealand asthma mortality epidemic. Int Arch Allergy Immunol. 1995;107:325-7.
20. Belongia EA, Hedberg CW, Gleich GJ, White KE, Mayeno AN, Loegering DA, et al. An investigation of the cause of the eosinophilia-myalgia syndrome associated with tryptophan use. N Engl J Med. 1990;323:357-65.
21. Morley C. Pumactant and poractant alfa in respiratory distress syndrome. Lancet. 2000;356:765.
22. Thomas SH, Drici MD, Hall GC, Crocq MA, Everitt B, Lader MH, et al. Safety of sertindole versus risperidone in schizophrenia: principal results of the sertindole cohort prospective study (SCoP). Acta Psychiatr Scand. 2010;122:345-55.
23. Dieppe PA, Shah E, Martin RM, Jüni P. Lessons from the withdrawal of rofecoxib: Patients would be safer if drug companies disclosed adverse events before licensing. BMJ. 2004;329:867-8.
24. Health Sciences Authority. Nefazodone and liver failure: update on Eprex® and pure red cell aplasia. Adv Drug React News. 2013;5:1-4.
25. Abadie SH, Samuels M. A fatality associated with dithiazanine iodide therapy. JAMA. 1965;192:326-7.
26. The New York Times. Glaxo agrees to pay $3 billion in fraud settlement. July 2, 2012. http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?_r=0.
27. European Medicines Agency. European Medicines Agency acts on deficiencies in Roche medicines-safety reporting. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/06/news_detail_001539.jsp&mid=WC0b01ac058004d5c1. Press release 21/06/2012.
28. Chetley A. A drug no-one needs. Health Action International, 1993. http://www.bukopharma.de/uploads/file/Archiv/Dipyrone-ADrugNo-oneNeeds.pdf.
29. Bhaumik S. India's health ministry bans pioglitazone, metamizole, and flupentixol-melitracen. BMJ. 2013;347:f4366.
30. The International Agranulocytosis and Aplastic Anemia Study. Risks of agranulocytosis and anemia: a first report of their relation to drug use with special reference to analgesics. JAMA. 1986;256:1749-57.
31. Menkes DB. Hazardous drugs in developing countries. BMJ. 1997;315:1557-8.
32. Psaty BM, Furberg CD, Ray WA, Weiss NS. Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis. JAMA. 2004;292:2622-31.
33. Stuckler D, Basu S, McKee M. Global health philanthropy and institutional relationships: how should conflicts of interest be addressed? PLoS Med. 2011;8:e1001020.
34. Anonymous. Conflicts of interest on adverse drug reactions. Emerg Med News. 2005;27:44-5.
35. Strom BL. Potential for conflict of interest in the evaluation of suspected adverse drug reactions: a counterpoint. JAMA. 2004;292:2643-6.
36. Finney DJ. An international drug safety program. J New Drugs. 1963;3:262-5.
37. Organisation mondiale de la santé. Série de rapports techniques. No. 425. Pharmaco-vigilance internationale: rôle de l'hôpital. Rapport d'une réunion de l'OMS. Genève: Organisation mondiale de la santé; 1969.
38. Evans SJW, Nitsch D. Statistics: analysis and presentation of safety data. In: Talbot J, Aronson JK, editors. Stephens' Detection and Evaluation of Adverse Drug Reactions: Principles and Practice. 6th ed. Oxford: Wiley-Blackwell; 2011. p. 348-88.
39. Loke YK, Price D, Herxheimer A, the Cochrane Adverse Effects Methods Group. Systematic reviews of adverse effects: framework for a structured approach. BMC Med Res Methodol. 2007;7:32.
40. Aronson JK, Hauben M. Anecdotes that provide definitive evidence. BMJ. 2006;332:1267-9.
41. Hauben M, Madigan D, Gerrits CM, Walsh L, Van Puijenbroek EP. The role of data mining in pharmacovigilance. Expert Opin Drug Saf. 2005;4:929-48.
42. 99mTc] fanolesomab). 2009-05-14. www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152014.htm.
43. Curtis SH. Sudden death following the intravenous injection of bismuth tartrate. JAMA. 1930;95:1588-9.
44. Agbabiaka TB, Savović J, Ernst E. Methods for causality assessment of adverse drug reactions: a systematic review. Drug Saf. 2008;31:21-37.
45. Aronson JK. Causality assessment. In: Talbot J, Aronson JK, editors. Stephens' Detection and Evaluation of Adverse Drug Reactions: Principles and Practice. 6th ed. Oxford: Wiley-Blackwell; 2011. p. 64-7.
46. Breckenridge A. Development and delivery of clinical pharmacology in regulatory agencies. Br J Clin Pharmacol. 2012;73:866-9.
47. International Conference on Harmonization. Clinical safety data management: definitions and standards for expedited reporting (ICH E2A). Geneva: International Conferences on Harmonization, 27 October 1994. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2A/Step4/E2A_Guideline.pdf.
48. European Medicines Agency. Standard Operating Procedure. 21 Sept 2010. http://www.ema.europa.eu/docs/en_GB/document_library/Standard_Operating_Procedure_-_SOP/2010/10/WC500098412.pdf.
49. United States Food and Drug Administration. Regulatory Procedures Manual-July 2012. Chapter 7 Recall Procedures. http://www.fda.gov/downloads/iceci/compliancemanuals/regulatoryProceduresManual/UCM074312.pdf._rfcollab United States Food and Drug Administration
50. India Central Drug Standard Control Organization. Guidelines on recall and rapid alert system for drugs (including biological and vaccines). http://www.cdsco.nic.in/writereaddata/Guidlines%20on%20Recall.pdf. [Accessed 1 May 2013].
51. Australia Therapeutic Goods Administration. Uniform Recall Procedure for Therapeutic Goods. 2004 edition. Version 1.6, September 2014. https://www.tga.gov.au/publication/uniform-recall-procedure-therapeutic-goods-urptghttps://www.tga.gov.au/publication/uniform-recall-procedure-therapeutic-goods-urptg.
52. Bakke OM, Wardell WM, Lasagna L. Drug discontinuations in the United Kingdom and the United States, 1964 to 1983: issues of safety. Clin Pharmacol Ther. 1984;35:559-67.
53. Abraham J, Davis C. A comparative analysis of drug safety withdrawals in the UK and the US (1971-1992): implications for current regulatory thinking and policy. Soc Sci Med. 2005;61:881-92.
54. Cohen D. EMA consults public on plan to increase transparency of drug trial data. BMJ. 2013;346:f4124.
55. Aronson JK. Guidelines and a checklist for reporting suspected adverse drug reactions anecdotally in journals. In: Talbot J, Aronson JK, editors. Stephens' Detection and Evaluation of Adverse Drug Reactions: Principles and Practice. 6th ed. Oxford: Wiley-Blackwell; 2011. p. 699-708.
56. Gagnier JJ, Kienle G, Altman DG, Moher D, Sox H, Riley D, et al. The CARE guidelines: consensus-based clinical case report guideline development. BMJ Case Rep. 2013;7:223.
57. Huggett B. How Tysabri survived. Nat Biotechnol. 2009;27:986.