Correlation versus Causation? Pharmacovigilance of the Analgesic Flupirtine Exemplifies the Need for Refined Spontaneous ADR Reporting
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{"title"=>"Correlation versus causation? pharmacovigilance of the analgesic flupirtine exemplifies the need for refined spontaneous adr reporting", "type"=>"journal", "authors"=>[{"first_name"=>"Nora", "last_name"=>"Anderson", "scopus_author_id"=>"14631498300"}, {"first_name"=>"Juergen", "last_name"=>"Borlak", "scopus_author_id"=>"7004331591"}], "year"=>2011, "source"=>"PLoS ONE", "identifiers"=>{"scopus"=>"2-s2.0-80054122083", "isbn"=>"1932-6203 (Electronic) 1932-6203 (Linking)", "doi"=>"10.1371/journal.pone.0025221", "pui"=>"362755709", "sgr"=>"80054122083", "issn"=>"19326203", "pmid"=>"22022383"}, "id"=>"b1d3bb69-a654-3145-a8e6-e37e18ce41a4", "abstract"=>"Annually, adverse drug reactions result in more than 2,000,000 hospitalizations and rank among the top 10 causes of death in the United States. Consequently, there is a need to continuously monitor and to improve the safety assessment of marketed drugs. Nonetheless, pharmacovigilance practice frequently lacks causality assessment. Here, we report the case of flupirtine, a centrally acting non-opioid analgesic. We re-evaluated the plausibility and causality of 226 unselected, spontaneously reported hepatobiliary adverse drug reactions according to the adapted Bradford-Hill criteria, CIOMS score and WHO-UMC scales. Thorough re-evaluation showed that only about 20% of the reported cases were probable or likely for flupirtine treatment, suggesting an incidence of flupirtine-related liver injury of 1∶100,000 when estimated prescription data are considered, or 0.8 in 10,000 on the basis of all 226 reported adverse drug reactions. Neither daily or cumulative dose nor duration of treatment correlated with markers of liver injury. In the majority of cases (151/226), an average of 3 co-medications with drugs known for their liver liability was observed that may well be causative for adverse drug reactions, but were reported under a suspected flupirtine ADR. Our study highlights the need to improve the quality and standards of ADR reporting. This should be done with utmost care taking into account contributing factors such as concomitant medications including over-the-counter drugs, the medical history and current health conditions, in order to avoid unjustified flagging and drug warnings that may erroneously cause uncertainty among healthcare professionals and patients, and may eventually lead to unjustified safety signals of useful drugs with a reasonable risk to benefit ratio.", "link"=>"http://www.mendeley.com/research/correlation-versus-causation-pharmacovigilance-analgesic-flupirtine-exemplifies-need-refined-spontan", "reader_count"=>33, "reader_count_by_academic_status"=>{"Unspecified"=>1, "Professor > Associate Professor"=>1, "Student > Doctoral Student"=>3, "Researcher"=>4, "Student > Ph. D. Student"=>7, "Student > Postgraduate"=>3, "Student > Master"=>9, "Other"=>3, "Student > Bachelor"=>2}, "reader_count_by_user_role"=>{"Unspecified"=>1, "Professor > Associate Professor"=>1, "Student > Doctoral Student"=>3, "Researcher"=>4, "Student > Ph. D. Student"=>7, "Student > Postgraduate"=>3, "Student > Master"=>9, "Other"=>3, "Student > Bachelor"=>2}, "reader_count_by_subject_area"=>{"Unspecified"=>2, "Environmental Science"=>1, "Nursing and Health Professions"=>1, "Medicine and Dentistry"=>20, "Agricultural and Biological Sciences"=>1, "Neuroscience"=>1, "Pharmacology, Toxicology and Pharmaceutical Science"=>3, "Business, Management and Accounting"=>1, "Psychology"=>1, "Chemistry"=>2}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>20}, "Neuroscience"=>{"Neuroscience"=>1}, "Chemistry"=>{"Chemistry"=>2}, "Psychology"=>{"Psychology"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>1}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>1}, "Unspecified"=>{"Unspecified"=>2}, "Environmental Science"=>{"Environmental Science"=>1}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>3}}, "reader_count_by_country"=>{"Finland"=>1}, "group_count"=>5}

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Figshare

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  • {"files"=>["https://ndownloader.figshare.com/files/725715"], "description"=>"<p>Annually spontaneously hepatobiliary adverse events reported for flupirtine (black) and proportion of cases rated to be ‘highly probable’ or ‘probable’ according to the CIOMS score (grey).</p>", "links"=>[], "tags"=>["reported", "cases", "flupirtine", "induced"], "article_id"=>396072, "categories"=>["Pharmacology", "Science Policy", "Medicine", "Biotechnology", "Immunology"], "users"=>["Nora Anderson", "Juergen Borlak"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0025221.g001", "stats"=>{"downloads"=>0, "page_views"=>2, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Annually_reported_cases_of_flupirtine_induced_liver_injury_/396072", "title"=>"Annually reported cases of flupirtine induced liver injury.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-10-11 01:41:12"}
  • {"files"=>["https://ndownloader.figshare.com/files/725809"], "description"=>"<p>Scatter plots of maximum AST (A), ALT (B), and bilirubin (C) levels (given in×ULN) in relation to the daily dose (left panel), cumulative doses (daily dose (mg)×duration of drug exposure (days), middle panel), and in relation to the time to onset (right panel) of the ADRs in cases of suspected hepatobiliary adverse events associated with flupirtine exposure.</p>", "links"=>[], "tags"=>["spontaneously", "reported"], "article_id"=>396170, "categories"=>["Pharmacology", "Science Policy", "Medicine", "Biotechnology", "Immunology"], "users"=>["Nora Anderson", "Juergen Borlak"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0025221.g002", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Results_of_liver_function_tests_of_spontaneously_reported_ADRs_/396170", "title"=>"Results of liver function tests of spontaneously reported ADRs.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-10-11 01:42:50"}
  • {"files"=>["https://ndownloader.figshare.com/files/726209"], "description"=>"<p>Sex and age distribution in 226 cases of spontaneously reported suspected ADRs to the German Federal Institute for Drugs and Medical Devices.</p>", "links"=>[], "tags"=>["226", "cases", "spontaneously", "reported", "suspected", "adrs", "german", "institute", "drugs"], "article_id"=>396558, "categories"=>["Pharmacology", "Science Policy", "Medicine", "Biotechnology", "Immunology"], "users"=>["Nora Anderson", "Juergen Borlak"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0025221.t002", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Sex_and_age_distribution_in_226_cases_of_spontaneously_reported_suspected_ADRs_to_the_German_Federal_Institute_for_Drugs_and_Medical_Devices_/396558", "title"=>"Sex and age distribution in 226 cases of spontaneously reported suspected ADRs to the German Federal Institute for Drugs and Medical Devices.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-10-11 01:49:18"}
  • {"files"=>["https://ndownloader.figshare.com/files/726170"], "description"=>"<p>Aims of post-marketing drug safety (pharmacovigilance) information reporting and management (adapted from Bate A et al., 2008 <a href=\"http://www.plosone.org/article/info:doi/10.1371/journal.pone.0025221#pone.0025221-Bate1\" target=\"_blank\">[28]</a>).</p>", "links"=>[], "tags"=>["post-marketing", "bate", "et", "2008"], "article_id"=>396527, "categories"=>["Pharmacology", "Science Policy", "Medicine", "Biotechnology", "Immunology"], "users"=>["Nora Anderson", "Juergen Borlak"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0025221.t001", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Aims_of_post_marketing_drug_safety_pharmacovigilance_information_reporting_and_management_adapted_from_Bate_A_et_al_2008_28_/396527", "title"=>"Aims of post-marketing drug safety (pharmacovigilance) information reporting and management (adapted from Bate A et al., 2008 [28]).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-10-11 01:48:47"}
  • {"files"=>["https://ndownloader.figshare.com/files/726043"], "description"=>"<p>Reporting scheme and critical issues in the management of suspected ADRs.</p>", "links"=>[], "tags"=>["issues", "suspected"], "article_id"=>396401, "categories"=>["Pharmacology", "Science Policy", "Medicine", "Biotechnology", "Immunology"], "users"=>["Nora Anderson", "Juergen Borlak"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0025221.g004", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Reporting_scheme_and_critical_issues_in_the_management_of_suspected_ADRs_/396401", "title"=>"Reporting scheme and critical issues in the management of suspected ADRs.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-10-11 01:46:41"}
  • {"files"=>["https://ndownloader.figshare.com/files/726233"], "description"=>"<p>Summary of the analyses of 226 spontaneous suspected ADRs reports.</p>", "links"=>[], "tags"=>["adapted", "bradford-hill"], "article_id"=>396595, "categories"=>["Pharmacology", "Science Policy", "Medicine", "Biotechnology", "Immunology"], "users"=>["Nora Anderson", "Juergen Borlak"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0025221.t003", "stats"=>{"downloads"=>5, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Causality_assessment_according_to_the_adapted_Bradford_Hill_criteria_/396595", "title"=>"Causality assessment according to the adapted Bradford-Hill criteria.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-10-11 01:49:55"}
  • {"files"=>["https://ndownloader.figshare.com/files/726278"], "description"=>"<p>Incidence of viral disease and cases with positive autoimmune titres in 226 cases of liver ADR linked to flupirtine treatment.</p>", "links"=>[], "tags"=>["viral", "cases", "autoimmune", "titres", "226", "adr", "linked", "flupirtine"], "article_id"=>396628, "categories"=>["Pharmacology", "Science Policy", "Medicine", "Biotechnology", "Immunology"], "users"=>["Nora Anderson", "Juergen Borlak"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0025221.t004", "stats"=>{"downloads"=>3, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Incidence_of_viral_disease_and_cases_with_positive_autoimmune_titres_in_226_cases_of_liver_ADR_linked_to_flupirtine_treatment_/396628", "title"=>"Incidence of viral disease and cases with positive autoimmune titres in 226 cases of liver ADR linked to flupirtine treatment.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-10-11 01:50:28"}
  • {"files"=>["https://ndownloader.figshare.com/files/726316"], "description"=>"<p>The 10 most common co-medications with a potential for hepatobiliary ADRs in n = 151 reported cases with co-medications possibly responsible or contributing factor(s) for hepatobiliary ADRs.</p>", "links"=>[], "tags"=>["10", "co-medications", "hepatobiliary", "adrs", "reported", "cases", "contributing"], "article_id"=>396663, "categories"=>["Pharmacology", "Science Policy", "Medicine", "Biotechnology", "Immunology"], "users"=>["Nora Anderson", "Juergen Borlak"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0025221.t005", "stats"=>{"downloads"=>1, "page_views"=>2, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_The_10_most_common_co_medications_with_a_potential_for_hepatobiliary_ADRs_in_n_8202_8202_151_reported_cases_with_co_medications_possibly_responsible_or_contributing_factor_s_for_hepatobiliary_ADRs_/396663", "title"=>"The 10 most common co-medications with a potential for hepatobiliary ADRs in n = 151 reported cases with co-medications possibly responsible or contributing factor(s) for hepatobiliary ADRs.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-10-11 01:51:03"}
  • {"files"=>["https://ndownloader.figshare.com/files/366840", "https://ndownloader.figshare.com/files/366879", "https://ndownloader.figshare.com/files/366925", "https://ndownloader.figshare.com/files/366963", "https://ndownloader.figshare.com/files/367000", "https://ndownloader.figshare.com/files/367038"], "description"=>"<div><p>Annually, adverse drug reactions result in more than 2,000,000 hospitalizations and rank among the top 10 causes of death in the United States. Consequently, there is a need to continuously monitor and to improve the safety assessment of marketed drugs. Nonetheless, pharmacovigilance practice frequently lacks causality assessment. Here, we report the case of flupirtine, a centrally acting non-opioid analgesic. We re-evaluated the plausibility and causality of 226 unselected, spontaneously reported hepatobiliary adverse drug reactions according to the adapted Bradford-Hill criteria, CIOMS score and WHO-UMC scales. Thorough re-evaluation showed that only about 20% of the reported cases were probable or likely for flupirtine treatment, suggesting an incidence of flupirtine-related liver injury of 1∶ 100,000 when estimated prescription data are considered, or 0.8 in 10,000 on the basis of all 226 reported adverse drug reactions. Neither daily or cumulative dose nor duration of treatment correlated with markers of liver injury. In the majority of cases (151/226), an average of 3 co-medications with drugs known for their liver liability was observed that may well be causative for adverse drug reactions, but were reported under a suspected flupirtine ADR. Our study highlights the need to improve the quality and standards of ADR reporting. This should be done with utmost care taking into account contributing factors such as concomitant medications including over-the-counter drugs, the medical history and current health conditions, in order to avoid unjustified flagging and drug warnings that may erroneously cause uncertainty among healthcare professionals and patients, and may eventually lead to unjustified safety signals of useful drugs with a reasonable risk to benefit ratio.</p> </div>", "links"=>[], "tags"=>["pharmacovigilance", "analgesic", "flupirtine", "exemplifies", "refined", "spontaneous", "adr"], "article_id"=>132504, "categories"=>["Pharmacology", "Science Policy", "Medicine", "Biotechnology", "Immunology"], "users"=>["Nora Anderson", "Juergen Borlak"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0025221.s001", "https://dx.doi.org/10.1371/journal.pone.0025221.s002", "https://dx.doi.org/10.1371/journal.pone.0025221.s003", "https://dx.doi.org/10.1371/journal.pone.0025221.s004", "https://dx.doi.org/10.1371/journal.pone.0025221.s005", "https://dx.doi.org/10.1371/journal.pone.0025221.s006"], "stats"=>{"downloads"=>10, "page_views"=>15, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Correlation_versus_Causation_Pharmacovigilance_of_the_Analgesic_Flupirtine_Exemplifies_the_Need_for_Refined_Spontaneous_ADR_Reporting/132504", "title"=>"Correlation versus Causation? Pharmacovigilance of the Analgesic Flupirtine Exemplifies the Need for Refined Spontaneous ADR Reporting", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2011-10-11 00:41:44"}
  • {"files"=>["https://ndownloader.figshare.com/files/725961"], "description"=>"<p>Laboratory results of a 53-year-old female patient after exposure and re-exposure to flupirtine. She experienced icterus with markedly increased serum transaminase levels. Upon discontinuation transaminase levels decreased. On day 6 of hospital admission re-exposure to an unknown dose of flupirtine resulted in a recurrent increase of laboratory values.</p>", "links"=>[], "tags"=>["hyper-sensitivity", "53-year-old"], "article_id"=>396315, "categories"=>["Pharmacology", "Science Policy", "Medicine", "Biotechnology", "Immunology"], "users"=>["Nora Anderson", "Juergen Borlak"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0025221.g003", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Flupirtine_hyper_sensitivity_of_a_53_year_old_female_patient_/396315", "title"=>"Flupirtine hyper-sensitivity of a 53-year-old female patient.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-10-11 01:45:15"}
  • {"files"=>["https://ndownloader.figshare.com/files/726130"], "description"=>"<p>\n <i>WHO-UMC causality assessment system categories were assigned to CIOMS score categories as follows: certain = highly probable+probable; probable/likely = probable, (highly probable); possible and possible/unclassified = possible; unlikely = unlikely, unclassified and unclassifiable = excluded.</i></p>", "links"=>[], "tags"=>["226", "cases", "suspected", "hepatobiliary", "adrs", "reported", "flupirtine", "cioms", "who-umc", "causality"], "article_id"=>396476, "categories"=>["Pharmacology", "Science Policy", "Medicine", "Biotechnology", "Immunology"], "users"=>["Nora Anderson", "Juergen Borlak"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0025221.t008", "stats"=>{"downloads"=>5, "page_views"=>11, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Evaluation_of_226_cases_with_suspected_hepatobiliary_ADRs_reported_for_flupirtine_obtained_with_the_CIOMS_score_and_the_WHO_UMC_causality_assessment_system_/396476", "title"=>"Evaluation of 226 cases with suspected hepatobiliary ADRs reported for flupirtine obtained with the CIOMS score and the WHO-UMC causality assessment system.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-10-11 01:47:56"}
  • {"files"=>["https://ndownloader.figshare.com/files/726396"], "description"=>"<p>Histopathological findings in liver biopsies taken from n = 49 patients with reported hepatobiliary ADRs (multiple histological findings were listed for one patient).</p>", "links"=>[], "tags"=>["findings", "biopsies", "taken", "patients", "reported", "hepatobiliary", "adrs", "histological", "listed"], "article_id"=>396746, "categories"=>["Pharmacology", "Science Policy", "Medicine", "Biotechnology", "Immunology"], "users"=>["Nora Anderson", "Juergen Borlak"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0025221.t007", "stats"=>{"downloads"=>1, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Histopathological_findings_in_liver_biopsies_taken_from_n_8202_8202_49_patients_with_reported_hepatobiliary_ADRs_multiple_histological_findings_were_listed_for_one_patient_/396746", "title"=>"Histopathological findings in liver biopsies taken from n = 49 patients with reported hepatobiliary ADRs (multiple histological findings were listed for one patient).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-10-11 01:52:26"}

PMC Usage Stats | Further Information

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Relative Metric

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