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Current Drug Safety

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ISSN (Print): 1574-8863
ISSN (Online): 2212-3911

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Review Article

Drug Withdrawal Due to Safety: A Review of the Data Supporting Withdrawal Decision

Author(s): Nuno Sales Craveiro*, Bruno Silva Lopes, Lara Tomás and Sofia Fraga Almeida

Volume 15, Issue 1, 2020

Page: [4 - 12] Pages: 9

DOI: 10.2174/1574886314666191004092520

Abstract

Introduction: Several drugs were withdrawn from the market due to safety.

Objective: The aim of this study was to describe data supporting drug withdrawal from the market due to safety reasons in countries belonging to the World Health Organization.

Methods: We analyzed drugs withdrawn from the market between 1990 and 2010. All medicine agencies of the countries belonging to the Program for International Drug Monitoring of the World Health Organization were contacted. To complete data, Medline, reference books and available drug databases were also searched. Information sources on which authorities based their withdrawal were categorized and the average time between the first date of exposure and withdrawal was calculated and stratified.

Results: A total of 133 drugs that met the inclusion/exclusion criteria were withdrawn from the market due to safety reasons in the period reviewed (1990 - 2010). Hepatotoxicity (n=36, 27.1%), cardiac disorders (n=25, 18.8%), hypersensitivity (n=17, 12.8%) and nephrotoxicity (n=14, 9.8%) were the major reasons responsible for 69.2% of all drugs withdrawn. In most cases, Information Sources for drug withdrawal were spontaneous reports and/or case reports (n=86, 64.7%), followed by clinical trials (n=24, 18.0%). The average time between the introduction of a drug and its withdrawal due to safety reasons was 20.3 years (SD±13.8).

Conclusion: According to available and published evidence, there is no gold standard to identify risks associated with drug exposure. These findings strengthen the role of different information sources within the drug safety review process.

Keywords: Hepatotoxicity, nephrotoxicity, program for international drug monitoring, clinical trials, observational studies, laboratory studies.

« Previous Next »
[1]
Olivier P, Montastruc JL. The nature of the scientific evidence leading to drug withdrawals for pharmacovigilance reasons in France. Pharmacoepidemiol Drug Saf 2006; 15(11): 808-12.
[http://dx.doi.org/10.1002/pds.1248] [PMID: 16700082]
[2]
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(1): 89-91.
[http://dx.doi.org/10.1007/s002280100265] [PMID: 11372600]
[3]
Lasser KE, Allen PD, Woolhandler SJ, Himmelstein DU, Wolfe SM, Bor DH. Timing of new black box warnings and withdrawals for prescription medications. JAMA 2002; 287: 2215-20.
[http://dx.doi.org/10.1001/jama.287.17.2215]
[4]
Fung M, Thornton A, Mybeck K, Hsiao-hui J, Hornbuckle K, Muniz E. Evaluation of the characteristics of safety withdrawal of prescription drugs from worldwide pharmaceutical markets – 1960 to 1999. Drug Inf J 2001; 35: 293-317.
[http://dx.doi.org/10.1177/009286150103500134]
[5]
Onakpoya IJ, Heneghan CJ, Aronson JK. Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: A systematic review of the world literature. BMC Med 2016; 14: 10.
[http://dx.doi.org/10.1186/s12916-016-0553-2] [PMID: 26843061]
[6]
Onakpoya IJ, Heneghan CJ, Aronson JK. Delays in the post-marketing withdrawal of drugs to which deaths have been attributed: A systematic investigation and analysis. BMC Med 2015; 13: 26.
[http://dx.doi.org/10.1186/s12916-014-0262-7] [PMID: 25651859]
[7]
WHO. Pharmaceuticals: Restrictions in use and availability (update of the Eighth Issue) Update of the. 8th ed. Geneva: World Health Organization 2005.
[8]
WHO. Pharmaceuticals: Restrictions in use and availability (Update of the Fourteenth Issue). Geneva: World Health Organization 2010.
[9]
WHO. Pharmaceuticals: Restrictions in use and availability (Update of the Twelfh Issue). Geneva: World Health Organization 2008.
[10]
Arlt VM, Stiborova M, Schmeiser HH. Aristolochic acid as a probable human cancer hazard in herbal remedies: A review. Mutagenesis 2002; 17(4): 265-77.
[http://dx.doi.org/10.1093/mutage/17.4.265] [PMID: 12110620]
[11]
UN. Consolidated list of products whose consumption and/or sale have been banned, withdrawn, severely restricted or not approved br governments. 12th ed. New York: United Nations 2005.
[12]
UN. Consolidated list of products whose consumption and/or sale have been banned, withdrawn, severely restricted. New York: United Nations 2009.
[13]
UN. Consolidated list of products whose consumption and/or sale have been banned, withdrawn, severely restricted or not approved br governments. New York: United Nations 2009.
[14]
Bunniran S, McCaffrey DJ III, Bentley JP, Bouldin AS. Pharmaceutical product withdrawal: Attributions of blame and its impact on trust. Res Social Adm Pharm 2009; 5(3): 262-73.
[http://dx.doi.org/10.1016/j.sapharm.2008.10.002] [PMID: 19733827]
[15]
Sittig M. Pharmaceutical manufacturing encyclopedia. 3rd ed. Norwich, New York, U.S.A.: William Andrew Publishing 2007.
[16]
Lee MH, Graham GG, Williams KM, Day RO. A benefit-risk assessment of benzbromarone in the treatment of gout. Was its withdrawal from the market in the best interest of patients? Drug Saf 2008; 31(8): 643-65.
[http://dx.doi.org/10.2165/00002018-200831080-00002] [PMID: 18636784]
[17]
Administration FD. List of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness--FDA. Proposed rule. Fed Regist 1998; 63(195): 54082-9.
[PMID: 10185826]
[18]
Ibáñez L, Ballarín E, Pérez E, Vidal X, Capellà D, Laporte JR. Agranulocytosis induced by pyrithyldione, a sedative hypnotic drug. Eur J Clin Pharmacol 2001; 27: 305-13.
[19]
Attia SM. Deleterious effects of reactive metabolites. Oxid Med Cell Longev 2010; 3(4): 238-53.
[http://dx.doi.org/10.4161/oxim.3.4.13246] [PMID: 20972370]
[20]
Sander M1. Spies CD, Martiny V, Rosenthal C, Wernecke KD, von Heymann C. Mortality associated with administration of highdose tranexamic acid and aprotinin in primary open-heart procedures: A retrospective analysis. Crit Care 2010; 14: R148.
[http://dx.doi.org/10.1186/cc9216] [PMID: 20682059]
[21]
Liu HH. Safety profile of the fluoroquinolones: Focus on levofloxacin. Drug Saf 2010; 33(5): 353-69.
[http://dx.doi.org/10.2165/11536360-000000000-00000] [PMID: 20397737]
[22]
Goldkind L, Laine L. A systematic review of NSAIDs withdrawn from the market due to hepatotoxicity: Lessons learned from the bromfenac experience. Pharmacoepidemiol Drug Saf 2006; 15(4): 213-20.
[http://dx.doi.org/10.1002/pds.1207] [PMID: 16456879]
[23]
Ibáñez L, Ballarín E, Pérez E, Vidal X, Capellà D, Laporte JR. Agranulocytosis induced by pyrithyldione, a sedative hypnotic drug. Eur J Clin Pharmacol 2000; 55(10): 761-4.
[http://dx.doi.org/10.1007/s002280050011] [PMID: 10663456]
[24]
Kasper D, Fauci A, Longo D, Hauser S, Jameson JL, Loscalzo J. Toxic and drug-induced hepatitis Harrison’s Principles of Internal Medicine. USA: McGraw-Hill 2011.
[25]
Ross JS, Madigan D, Hill KP, Egilman DS, Wang Y, Krumholz HM. Pooled analysis of rofecoxib placebo-controlled clinical trial data: Lessons for post-market pharmaceutical safety surveillance. Arch Intern Med 2009; 169(21): 1976-85.
[http://dx.doi.org/10.1001/archinternmed.2009.394] [PMID: 19933959]
[26]
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(5): 881-92.
[http://dx.doi.org/10.1016/j.socscimed.2005.01.004] [PMID: 15955393]
[27]
Krayenbühl JC, Vozeh S, Kondo-Oestreicher M, Dayer P. Drug-drug interactions of new active substances: Mibefradil example. Eur J Clin Pharmacol 1999; 55(8): 559-65.
[http://dx.doi.org/10.1007/s002280050673] [PMID: 10541773]
[28]
Brunton LL, Hilal-Dandan R, Knollmann BC. The pharmacological bases of Goodman and Gilman Therapeutics. 13th ed. Rio de Janeiro: McGraw-Hill 2018.
[29]
Agnelli G, Eriksson BI, Cohen AT, et al. Safety assessment of new antithrombotic agents: Lessons from the EXTEND study on ximelagatran. Thromb Res 2009; 123(3): 488-97.
[http://dx.doi.org/10.1016/j.thromres.2008.02.017] [PMID: 18485453]
[30]
Diane K, Wysowski LS. Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002. Arch Intern Med 2005; 165: 1363-9.
[http://dx.doi.org/10.1001/archinte.165.12.1363]
[31]
Fau D, Lekehal M, Farrell G, et al. Diterpenoids from germander, an herbal medicine, induce apoptosis in isolated rat hepatocytes. Gastroenterology 1997; 113: 1334-46.
[http://dx.doi.org/10.1053/gast.1997.v113.pm9322529]
[32]
CDER. Report to the Nation: Improving public health through human drugs. Rockville, Maryland: U.S. Food and Drug Administration 2005.
[33]
CDER. Report to the Nation: Improving public health through human drugs. Rockville, Maryland: U.S. Food and Drug Administration 2004.
[34]
CDER. Report to the Nation: Improving public health through human drugs. Rockville, Maryland: U.S. Food and Drug Administration 2003.
[35]
CDER. Report to the Nation: Improving public health through human drugs. Rockville, Maryland: U.S. Food and Drug Administration 2001.
[36]
CDER. Report to the Nation: Improving public health through human drugs. Rockville, Maryland: U.S. Food and Drug Administration 2002.
[37]
CDER. Report to the Nation: Improving public health through human drugs. Rockville, Maryland: U.S. Food and Drug Administration 2000.
[38]
CDER. Report to the Nation: Improving public health through human drugs. Rockville, Maryland: U.S. Food and Drug Administration 2007.
[39]
List of Globally identified Websites of Medicines Regulatory Authorities. Available from: http://www.who.int/medicines/areas/quality_safety/regulation_legislation/ListMRAWebsites.pdf2019
[40]
Hauben M, Bate A. Decision support methods for the detection of adverse events in post-marketing data. Drug Discov Today 2009; 14(7-8): 343-57.
[http://dx.doi.org/10.1016/j.drudis.2008.12.012] [PMID: 19187799]
[41]
Chan KA, Hauben M. Signal detection in pharmacovigilance: Empirical evaluation of data mining tools. Pharmacoepidemiol Drug Saf 2005; 14(9): 597-9.
[http://dx.doi.org/10.1002/pds.1128] [PMID: 16134080]

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