FDA, 2018, 2018
FDA, 2013
Watson, 2009, The New Food and Drug Administration Drug Package Insert: implications for patient safety and clinical care, Anesthesia Analgesia, 108, 211, 10.1213/ane.0b013e31818c1b27
McMahon, 2014, The package insert: who writes it and why, what are its implications, and how well does medical school explain it?, J Psychiatric Pract, 20, 284, 10.1097/01.pra.0000452565.83039.20
FDA, 2011
EMA, 2009
Kashoki, 2020, A comparison of EMA and FDA decisions for new drug marketing applications 2014–2016: concordance, discordance, and why, Clin Pharmacol Ther, 107, 195, 10.1002/cpt.1565
Bjornsson, 2015, Discrepancies in liver disease labeling in the package inserts of commonly prescribed medications, Gastroenterology, 148, 269, 10.1053/j.gastro.2014.12.007
DeMuro, 2013, Assessment of PRO label claims granted by the FDA as compared to the EMA (2006–2010), Value Health, 16, 1150, 10.1016/j.jval.2013.08.2293
Nieminen, 2005, Differences in product information of biopharmaceuticals in the EU and the USA: implications for product development, Eur J Pharm Biopharm, 60, 319, 10.1016/j.ejpb.2005.01.013
FDA, 2020
Ernst, 2001, Drug-related morbidity and mortality: updating the cost-of-illness model, J Am Pharm Assoc, 41, 192
Johnson, 1997, Drug-related morbidity and mortality and the economic impact of pharmaceutical care, Am J Health-Syst Pharm, 54, 554, 10.1093/ajhp/54.5.554
Lazarou, 1998, Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies, JAMA, 279, 1200, 10.1001/jama.279.15.1200
Murphy, 2006, ‘Black box’ 101: how the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk, J Allergy Clin Immunol, 117, 34, 10.1016/j.jaci.2005.10.031
Chen, 2016, DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans, Drug Discovery Today, 21, 648, 10.1016/j.drudis.2016.02.015
Suzuki, 2015, Comedications alter drug-induced liver injury reporting frequency: data mining in the WHO VigiBase™, Regulat Toxicol Pharmacol: RTP, 72, 481, 10.1016/j.yrtph.2015.05.004
Hoyumpa, 1982, Major drug interactions: effect of liver disease, alcohol, and malnutrition, Annu Rev Med, 33, 113, 10.1146/annurev.me.33.020182.000553
Franz, 2013, Dose adjustment in patients with liver cirrhosis: impact on adverse drug reactions and hospitalizations, Eur J Clin Pharmacol, 69, 1565, 10.1007/s00228-013-1502-z
Frye, 2006, Liver disease selectively modulates cytochrome P450–mediated metabolism, Clin Pharmacol Ther, 80, 235, 10.1016/j.clpt.2006.05.006
Chalasani, 2016, Drug-induced liver injury in patients with preexisting chronic liver disease in drug development: how to identify and manage?, Gastroenterology, 151, 1046, 10.1053/j.gastro.2016.10.010
Chalasani, 2010, Risk factors for idiosyncratic drug-induced liver injury, Gastroenterology, 138, 2246, 10.1053/j.gastro.2010.04.001
Lewis, 2002, The rational use of potentially hepatotoxic medications in patients with underlying liver disease, Expert Opin Drug Saf, 1, 159, 10.1517/14740338.1.2.159
Russo, 2004, Are patients with elevated liver tests at increased risk of drug-induced liver injury?, Gastroenterology, 126, 1477, 10.1053/j.gastro.2004.03.030
Fontana, 2009, Drug-Induced Liver Injury Network (DILIN) prospective study: rationale, design and conduct, Drug Saf, 32, 55, 10.2165/00002018-200932010-00005
Chen, 2011, FDA-approved drug labeling for the study of drug-induced liver injury, Drug Discovery Today, 16, 697, 10.1016/j.drudis.2011.05.007
Björnsson, 2016, Categorization of drugs implicated in causing liver injury: Critical assessment based on published case reports, Hepatology, 63, 590, 10.1002/hep.28323
Liang, 2002, FDA use of the black box warning: time for reevaluation as a safety tool, J Clin Anesth, 14, 561, 10.1016/S0952-8180(02)00444-0
Yarrington, 2019, Impact of FDA black box warning on fluoroquinolone and alternative antibiotic use in southeastern US hospitals, Infect Control Hosp Epidemiol, 40, 1297, 10.1017/ice.2019.247
McCormack, 2005, Metformin’s contraindications should be contraindicated, Can Med Assoc J, 173, 502, 10.1503/cmaj.045292
Zaremba, 2019, Metastatic Merkel cell carcinoma and myasthenia gravis: contraindication for therapy with immune checkpoint inhibitors?, J ImmunoTher Cancer, 7, 10.1186/s40425-019-0626-9
Björnsson, 2016, Hepatotoxicity by drugs: the most common implicated agents, Int J Mol Sci, 17, 224, 10.3390/ijms17020224
Chalasani, 2015, Features and outcomes of 899 patients with drug-induced liver injury: The DILIN Prospective Study, Gastroenterology, 148, 1340, 10.1053/j.gastro.2015.03.006
Suzuki, 2010, Drugs associated with hepatotoxicity and their reporting frequency of liver adverse events in VigiBaseTM, Drug Saf, 33, 503, 10.2165/11535340-000000000-00000
Rockey, 2010, Causality assessment in drug-induced liver injury using a structured expert opinion process: comparison to the Roussel-Uclaf causality assessment method, Hepatology, 51, 2117, 10.1002/hep.23577
Hey-Hadavi, 2021, Overview of causality assessment for drug-induced liver injury (DILI) in clinical trials, Drug Saf, 44, 619, 10.1007/s40264-021-01051-5
Hazell, 2006, Under-reporting of adverse drug reactions: a systematic review, Drug Saf, 29, 385, 10.2165/00002018-200629050-00003
Alatawi, 2017, Empirical estimation of under-reporting in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), Expert Opin Drug Saf, 16, 761, 10.1080/14740338.2017.1323867
Tomlin, 2012, Methods for retrospective detection of drug safety signals and adverse events in electronic general practice records, Drug Saf, 35, 733, 10.1007/BF03261970