Drug-induced liver injury associated with lopinavir-ritonavir in patients with COVID-19: a disproportionality analysis of U.S. food and drug administration adverse event reporting system (FAERS) data

{ 'indexed': { 'date-parts': [[2022, 11, 19]], 'date-time': '2022-11-19T07:27:12Z', 'timestamp': 1668842832298}, 'reference-count': 17, 'publisher': 'Springer Science and Business Media LLC', 'issue': '4', 'license': [ { 'start': { 'date-parts': [[2021, 7, 30]], 'date-time': '2021-07-30T00:00:00Z', 'timestamp': 1627603200000}, 'content-version': 'tdm', 'delay-in-days': 0, 'URL': 'https://www.springer.com/tdm'}, { 'start': { 'date-parts': [[2021, 7, 30]], 'date-time': '2021-07-30T00:00:00Z', 'timestamp': 1627603200000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://www.springer.com/tdm'}], 'content-domain': {'domain': ['link.springer.com'], 'crossmark-restriction': False}, 'published-print': {'date-parts': [[2021, 8]]}, 'DOI': '10.1007/s11096-021-01311-5', 'type': 'journal-article', 'created': {'date-parts': [[2021, 7, 30]], 'date-time': '2021-07-30T15:02:53Z', 'timestamp': 1627657373000}, 'page': '1116-1122', 'update-policy': 'http://dx.doi.org/10.1007/springer_crossmark_policy', 'source': 'Crossref', 'is-referenced-by-count': 2, 'title': 'Drug-induced liver injury associated with lopinavir-ritonavir in patients with COVID-19: a ' 'disproportionality analysis of U.S. food and drug administration adverse event reporting system ' '(FAERS) data', 'prefix': '10.1007', 'volume': '43', 'author': [ { 'ORCID': 'http://orcid.org/0000-0002-5814-6657', 'authenticated-orcid': False, 'given': 'Huilin', 'family': 'Tang', 'sequence': 'first', 'affiliation': []}, {'given': 'Liyuan', 'family': 'Zhou', 'sequence': 'additional', 'affiliation': []}, {'given': 'Xiaotong', 'family': 'Li', 'sequence': 'additional', 'affiliation': []}, {'given': 'Alan C.', 'family': 'Kinlaw', 'sequence': 'additional', 'affiliation': []}, {'given': 'Jeff Y.', 'family': 'Yang', 'sequence': 'additional', 'affiliation': []}, {'given': 'Andrew M.', 'family': 'Moon', 'sequence': 'additional', 'affiliation': []}, {'given': 'Edward L.', 'family': 'Barnes', 'sequence': 'additional', 'affiliation': []}, {'given': 'Tiansheng', 'family': 'Wang', 'sequence': 'additional', 'affiliation': []}], 'member': '297', 'published-online': {'date-parts': [[2021, 7, 30]]}, 'reference': [ { 'key': '1311_CR1', 'doi-asserted-by': 'crossref', 'unstructured': 'Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, ' 'Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, ' 'Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. ' 'Clinical features of patients infected with 2019 novel coronavirus in ' 'Wuhan, China. Lancet. 2020;395(10223):497–506.', 'DOI': '10.1016/S0140-6736(20)30183-5'}, { 'issue': '5', 'key': '1311_CR2', 'doi-asserted-by': 'publisher', 'first-page': '428', 'DOI': '10.1016/S2468-1253(20)30057-1', 'volume': '5', 'author': 'C Zhang', 'year': '2020', 'unstructured': 'Zhang C, Shi L, Wang FS. Liver injury in COVID-19: management and ' 'challenges. Lancet Gastroenterol Hepatol. 2020;5(5):428–30.', 'journal-title': 'Lancet Gastroenterol Hepatol'}, { 'key': '1311_CR3', 'doi-asserted-by': 'crossref', 'unstructured': 'Olry A, Meunier L, Delire B, Larrey D, Horsmans Y, Le Louet H. ' 'Drug-Induced Liver Injury and COVID-19 Infection: The Rules Remain the ' 'Same. Drug Saf. 2020;43(7):615–7', 'DOI': '10.1007/s40264-020-00954-z'}, { 'key': '1311_CR4', 'doi-asserted-by': 'crossref', 'unstructured': 'Osborne V, Davies M, Lane S, Evans A, Denyer J, Dhanda S, Roy D, Shakir ' 'S. Lopinavir-ritonavir in the treatment of COVID-19: a dynamic ' 'systematic benefit-risk assessment. Drug Saf. 2020;43(8):809–21.', 'DOI': '10.1007/s40264-020-00966-9'}, { 'key': '1311_CR5', 'doi-asserted-by': 'crossref', 'unstructured': 'Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei ' 'M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan ' 'Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu ' 'X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu ' 'Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia ' 'C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang ' 'C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A trial of ' 'lopinavir-ritonavir in adults hospitalized with severe Covid-19. N Engl ' 'J Med. 2020;382(19):1787–99', 'DOI': '10.1056/NEJMoa2001282'}, { 'key': '1311_CR6', 'doi-asserted-by': 'crossref', 'unstructured': 'Gahr M, Zeiss R, Lang D, Connemann BJ, Hiemke C, Schonfeldt-Lecuona C. ' 'Drug-induced liver injury associated with antidepressive ' 'psychopharmacotherapy: an explorative assessment based on quantitative ' 'signal detection using different MedDRA terms. J Clin Pharmacol. ' '2016;56(6):769–78.', 'DOI': '10.1002/jcph.662'}, { 'issue': '8', 'key': '1311_CR7', 'doi-asserted-by': 'publisher', 'first-page': '519', 'DOI': '10.1002/pds.1001', 'volume': '13', 'author': 'KJ Rothman', 'year': '2004', 'unstructured': 'Rothman KJ, Lanes S, Sacks ST. The reporting odds ratio and its ' 'advantages over the proportional reporting ratio. Pharmacoepidemiol Drug ' 'Saf. 2004;13(8):519–23.', 'journal-title': 'Pharmacoepidemiol Drug Saf'}, { 'issue': '2', 'key': '1311_CR8', 'doi-asserted-by': 'publisher', 'first-page': '157', 'DOI': '10.1038/sj.clpt.6100258', 'volume': '82', 'author': 'JS Almenoff', 'year': '2007', 'unstructured': 'Almenoff JS, Pattishall EN, Gibbs TG, DuMouchel W, Evans SJ, Yuen N. ' 'Novel statistical tools for monitoring the safety of marketed drugs. ' 'Clin Pharmacol Ther. 2007;82(2):157–66', 'journal-title': 'Clin Pharmacol Ther'}, { 'key': '1311_CR9', 'doi-asserted-by': 'crossref', 'unstructured': 'Sherman KE, Shire NJ, Cernohous P, Rouster SD, Omachi JH, Brun S, Da ' 'Silva B. Liver injury and changes in hepatitis C Virus (HCV) RNA load ' 'associated with protease inhibitor-based antiretroviral therapy for ' 'treatment-naive HCV-HIV-coinfected patients: lopinavir-ritonavir versus ' 'nelfinavir. Clin Infect Dis. 2005;41(8):1186–95.', 'DOI': '10.1086/444501'}, { 'key': '1311_CR10', 'doi-asserted-by': 'crossref', 'unstructured': 'Cai Q, Huang D, Yu H, Zhu Z, Xia Z, Su Y, Li Z, Zhou G, Gou J, Qu J, Sun ' 'Y, Liu Y, He Q, Chen J, Liu L, Xu L. COVID-19: Abnormal liver function ' 'tests. J Hepatol. 2020;73(3):566–74.', 'DOI': '10.1016/j.jhep.2020.04.006'}, { 'issue': '7', 'key': '1311_CR11', 'doi-asserted-by': 'publisher', 'first-page': '1561', 'DOI': '10.1016/j.cgh.2020.04.002', 'volume': '18', 'author': 'Z Fan', 'year': '2020', 'unstructured': 'Fan Z, Chen L, Li J, Cheng X, Yang J, Tian C, Zhang Y, Huang S, Liu Z, ' 'Cheng J. Clinical Features of COVID-19-Related Liver Functional ' 'Abnormality. Clin Gastroenterol Hepatol. 2020;18(7):1561–6.', 'journal-title': 'Clin Gastroenterol Hepatol'}, { 'issue': '1 Suppl', 'key': '1311_CR12', 'doi-asserted-by': 'publisher', 'first-page': 'S132', 'DOI': '10.1016/j.jhep.2005.11.027', 'volume': '44', 'author': 'M Nunez', 'year': '2006', 'unstructured': 'Nunez M. Hepatotoxicity of antiretrovirals: incidence, mechanisms and ' 'management. J Hepatol. 2006;44(1 Suppl):S132–9.', 'journal-title': 'J Hepatol'}, { 'issue': '3', 'key': '1311_CR13', 'doi-asserted-by': 'publisher', 'first-page': '155', 'DOI': '10.1038/s41584-020-0372-x', 'volume': '16', 'author': 'E Schrezenmeier', 'year': '2020', 'unstructured': 'Schrezenmeier E, Dorner T. Mechanisms of action of hydroxychloroquine ' 'and chloroquine: implications for rheumatology. Nat Rev Rheumatol. ' '2020;16(3):155–66.', 'journal-title': 'Nat Rev Rheumatol'}, { 'key': '1311_CR14', 'unstructured': 'Recovery Collaborative Group. Lopinavir-ritonavir in patients admitted ' 'to hospital with COVID-19 (RECOVERY): a randomised, controlled, ' 'open-label, platform trial. Lancet. 2021;396(10259):1345–52.'}, { 'key': '1311_CR15', 'doi-asserted-by': 'crossref', 'unstructured': 'Rochwerg B, Agarwal A, Siemieniuk RA, Agoritsas T, Lamontagne F, Askie ' 'L, Lytvyn L, Leo YS, Macdonald H, Zeng L, Amin W, Burhan E, Bausch FJ, ' 'Calfee CS, Cecconi M, Chanda D, Du B, Geduld H, Gee P, Harley N, Hashimi ' 'M, Hunt B, Kabra SK, Kanda S, Kawano-Dourado L, Kim YJ, Kissoon N, ' 'Kwizera A, Mahaka I, Manai H, Mino G, Nsutebu E, Preller J, Pshenichnaya ' 'N, Qadir N, Sabzwari S, Sarin R, Shankar-Hari M, Sharland M, Shen Y, ' 'Ranganathan SS, Souza JP, Stegemann M, De Sutter A, Ugarte S, ' 'Venkatapuram S, Dat VQ, Vuyiseka D, Wijewickrama A, Maguire B, Zeraatkar ' 'D, Bartoszko JJ, Ge L, Brignardello-Petersen R, Owen A, Guyatt G, Diaz ' 'J, Jacobs M, Vandvik PO. A living WHO guideline on drugs for covid-19. ' 'BMJ. 2020;370m3379.', 'DOI': '10.1136/bmj.m3379'}, { 'key': '1311_CR16', 'unstructured': 'Infections disease society of America. IDSA guidelines on the treatment ' 'and management of patients with COVID-19. 2021 June 25,2021 [cited 2021 ' 'July 8]; Available from: ' 'https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/.'}, { 'key': '1311_CR17', 'unstructured': 'US Food and Drug Administration. Coronavirus (COVID-19) Update: FDA ' 'revokes emergency use authorization for chloroquine and ' 'hydroxychloroquine. 2020 06/15 [cited 2021 July 9]; Available from: ' 'https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and.'}], 'container-title': 'International Journal of Clinical Pharmacy', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://link.springer.com/content/pdf/10.1007/s11096-021-01311-5.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/article/10.1007/s11096-021-01311-5/fulltext.html', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/content/pdf/10.1007/s11096-021-01311-5.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2021, 8, 9]], 'date-time': '2021-08-09T19:30:57Z', 'timestamp': 1628537457000}, 'score': 1, 'resource': {'primary': {'URL': 'https://link.springer.com/10.1007/s11096-021-01311-5'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2021, 7, 30]]}, 'references-count': 17, 'journal-issue': {'issue': '4', 'published-print': {'date-parts': [[2021, 8]]}}, 'alternative-id': ['1311'], 'URL': 'http://dx.doi.org/10.1007/s11096-021-01311-5', 'relation': {}, 'ISSN': ['2210-7703', '2210-7711'], 'subject': ['Pharmacology (medical)', 'Pharmaceutical Science', 'Pharmacology', 'Toxicology', 'Pharmacy'], 'container-title-short': 'Int J Clin Pharm', 'published': {'date-parts': [[2021, 7, 30]]}, 'assertion': [ { 'value': '4 May 2021', 'order': 1, 'name': 'received', 'label': 'Received', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '21 July 2021', 'order': 2, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '30 July 2021', 'order': 3, 'name': 'first_online', 'label': 'First Online', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, {'order': 1, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Declarations'}}, { 'value': 'HT is a consultant for Evidpro, LLC. The other authors have no conflict of ' 'interest to declare.', 'order': 2, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Conflicts of interest'}}, { 'value': 'This content has been made available to all.', 'name': 'free', 'label': 'Free to read'}]}