Valproic Acid and Fatalities in Children: A Review of Individual Case Safety Reports in VigiBase
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{"title"=>"Valproic acid and fatalities in children: A review of individual case safety reports in VigiBase", "type"=>"generic", "authors"=>[{"first_name"=>"Kristina", "last_name"=>"Star", "scopus_author_id"=>"24077399800"}, {"first_name"=>"I. Ralph", "last_name"=>"Edwards", "scopus_author_id"=>"35829653800"}, {"first_name"=>"Imti", "last_name"=>"Choonara", "scopus_author_id"=>"7005457874"}], "year"=>2014, "source"=>"PLoS ONE", "identifiers"=>{"pui"=>"600125292", "scopus"=>"2-s2.0-84907841730", "pmid"=>"25302991", "sgr"=>"84907841730", "doi"=>"10.1371/journal.pone.0108970", "issn"=>"19326203"}, "id"=>"d1ee5aed-5950-382c-8676-a0827abf12df", "abstract"=>"INTRODUCTION: Valproic acid is an effective first line drug for the treatment of epilepsy. Hepatotoxicity is a rare and potentially fatal adverse reaction for this medicine.\\n\\nOBJECTIVE: Firstly to characterise valproic acid reports on children with fatal outcome and secondly to determine reporting over time of hepatotoxicity with fatal outcome.\\n\\nMETHODS: Individual case safety reports (ICSRs) for children ≤ 17 years with valproic acid and fatal outcome were retrieved from the WHO Global ICSR database, VigiBase, in June 2013. Reports were classified into hepatotoxic reactions or other reactions. Shrinkage observed-to-expected ratios were used to explore the relative reporting trend over time and for patient age. The frequency of polytherapy, i.e. reports with more than one antiepileptic medicine, was investigated.\\n\\nRESULTS: There have been 268 ICSRs with valproic acid and fatal outcome in children, reported from 25 countries since 1977. A total of 156 fatalities were reported with hepatotoxicity, which has been continuously and disproportionally reported over time. There were 31 fatalities with pancreatitis. Other frequently reported events were coma/encephalopathy, seizures, respiratory disorders and coagulopathy. Hepatotoxicity was disproportionally and most commonly reported in children aged 6 years and under (104/156 reports) but affected children of all ages. Polytherapy was significantly more frequently reported for valproic acid with fatal outcome (58%) compared with non-fatal outcome (34%).\\n\\nCONCLUSION: Hepatotoxicity remains a considerable problem. The risk appears to be greatest in young children (6 years and below) but can occur at any age. Polytherapy is commonly reported and seems to be a risk factor for hepatotoxicity, pancreatitis and other serious adverse drug reactions with valproic acid.", "link"=>"http://www.mendeley.com/research/valproic-acid-fatalities-children-review-individual-case-safety-reports-vigibase", "reader_count"=>27, "reader_count_by_academic_status"=>{"Unspecified"=>1, "Librarian"=>1, "Researcher"=>4, "Student > Ph. D. Student"=>4, "Student > Postgraduate"=>3, "Other"=>5, "Student > Master"=>5, "Student > Bachelor"=>3, "Lecturer"=>1}, "reader_count_by_user_role"=>{"Unspecified"=>1, "Librarian"=>1, "Researcher"=>4, "Student > Ph. D. Student"=>4, "Student > Postgraduate"=>3, "Other"=>5, "Student > Master"=>5, "Student > Bachelor"=>3, "Lecturer"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>3, "Medicine and Dentistry"=>16, "Agricultural and Biological Sciences"=>2, "Pharmacology, Toxicology and Pharmaceutical Science"=>4, "Computer Science"=>1, "Immunology and Microbiology"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>16}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>2}, "Computer Science"=>{"Computer Science"=>1}, "Unspecified"=>{"Unspecified"=>3}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>4}}, "group_count"=>3}

Scopus | Further Information

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  • {"files"=>["https://ndownloader.figshare.com/files/1713176"], "description"=>"<p>*Reports recorded with more than one suspected, interacting or concomitant antiepileptic medicine.</p><p>Overall reporting of valproic acid and fatal outcome reports in children with and without hepatotoxicity before and after 1990.</p>", "links"=>[], "tags"=>["hepatotoxicity", "Global ICSR database", "outcome.MethodsIndividual case safety reports", "valproic acid", "Individual Case Safety Reports", "June 2013. Reports", "VigiBase IntroductionValproic acid", "characterise valproic acid reports"], "article_id"=>1200566, "categories"=>["Biological Sciences"], "users"=>["Kristina Star", "I. Ralph Edwards", "Imti Choonara"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0108970.t002", "stats"=>{"downloads"=>0, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Overall_reporting_of_valproic_acid_and_fatal_outcome_reports_in_children_with_and_without_hepatotoxicity_before_and_after_1990_/1200566", "title"=>"Overall reporting of valproic acid and fatal outcome reports in children with and without hepatotoxicity before and after 1990.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-10-10 03:05:01"}
  • {"files"=>["https://ndownloader.figshare.com/files/1713177"], "description"=>"<p>*Reports recorded with more than one suspected, interacting or concomitant antiepileptic drug.</p><p>Age groups and polytherapy<sup><a href=\"http://www.plosone.org/article/info:doi/10.1371/journal.pone.0108970#nt102\" target=\"_blank\">*</a></sup> for valproic acid and fatal outcome reports, with and without hepatoxicity.</p>", "links"=>[], "tags"=>["hepatotoxicity", "Global ICSR database", "outcome.MethodsIndividual case safety reports", "valproic acid", "Individual Case Safety Reports", "June 2013. Reports", "VigiBase IntroductionValproic acid", "characterise valproic acid reports"], "article_id"=>1200567, "categories"=>["Biological Sciences"], "users"=>["Kristina Star", "I. Ralph Edwards", "Imti Choonara"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0108970.t003", "stats"=>{"downloads"=>1, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Age_groups_and_polytherapy_for_valproic_acid_and_fatal_outcome_reports_with_and_without_hepatoxicity_/1200567", "title"=>"Age groups and polytherapy<sup>*</sup> for valproic acid and fatal outcome reports, with and without hepatoxicity.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-10-10 03:05:01"}
  • {"files"=>["https://ndownloader.figshare.com/files/1713178"], "description"=>"<p>*Numbers do not add up, since more than one antiepileptic drug (AED) could be recorded on one report. AEDs could have been recorded as suspected, interacting or concomitant medicines on the reports.</p><p>The ten most frequently co-reported antiepileptic drugs with valproic acid and fatal outcome in children.<sup><a href=\"http://www.plosone.org/article/info:doi/10.1371/journal.pone.0108970#nt103\" target=\"_blank\">*</a></sup></p>", "links"=>[], "tags"=>["hepatotoxicity", "Global ICSR database", "outcome.MethodsIndividual case safety reports", "valproic acid", "Individual Case Safety Reports", "June 2013. Reports", "VigiBase IntroductionValproic acid", "characterise valproic acid reports"], "article_id"=>1200568, "categories"=>["Biological Sciences"], "users"=>["Kristina Star", "I. Ralph Edwards", "Imti Choonara"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0108970.t004", "stats"=>{"downloads"=>0, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_The_ten_most_frequently_co_reported_antiepileptic_drugs_with_valproic_acid_and_fatal_outcome_in_children_/1200568", "title"=>"The ten most frequently co-reported antiepileptic drugs with valproic acid and fatal outcome in children.<sup>*</sup>", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-10-10 03:05:01"}
  • {"files"=>["https://ndownloader.figshare.com/files/1713179"], "description"=>"<p>*Reports recorded with more than one suspected, interacting or concomitant antiepileptic drug.</p><p>**The lower level of the 99% credibility interval for the log shrinkage odds ratio (OR005) was considered significant when above zero.</p><p>Valproic acid reports with polytherapy<sup><a href=\"http://www.plosone.org/article/info:doi/10.1371/journal.pone.0108970#nt104\" target=\"_blank\">*</a></sup> and fatal outcome were contrasted with non-fatal outcome reports in children, grouped by reports with or without hepatotoxicity, or with any event.</p>", "links"=>[], "tags"=>["hepatotoxicity", "Global ICSR database", "outcome.MethodsIndividual case safety reports", "valproic acid", "Individual Case Safety Reports", "June 2013. Reports", "VigiBase IntroductionValproic acid", "characterise valproic acid reports"], "article_id"=>1200569, "categories"=>["Biological Sciences"], "users"=>["Kristina Star", "I. Ralph Edwards", "Imti Choonara"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0108970.t005", "stats"=>{"downloads"=>6, "page_views"=>12, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Valproic_acid_reports_with_polytherapy_and_fatal_outcome_were_contrasted_with_non_fatal_outcome_reports_in_children_grouped_by_reports_with_or_without_hepatotoxicity_or_with_any_event_/1200569", "title"=>"Valproic acid reports with polytherapy<sup>*</sup> and fatal outcome were contrasted with non-fatal outcome reports in children, grouped by reports with or without hepatotoxicity, or with any event.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-10-10 03:05:01"}
  • {"files"=>["https://ndownloader.figshare.com/files/1713180"], "description"=>"<p>Numbers do not add up, since one report can be recorded with more than one reaction.</p><p>*‘Hep’ are reports with hepatotoxicity events recorded and ‘Non-Hep’ reports are without hepatotoxicity events recorded.</p><p>**Reports recorded with more than one suspected, interacting or concomitant antiepileptic drug.</p><p>The most frequently reported adverse reactions for valproic acid with fatal outcome in children.</p>", "links"=>[], "tags"=>["hepatotoxicity", "Global ICSR database", "outcome.MethodsIndividual case safety reports", "valproic acid", "Individual Case Safety Reports", "June 2013. Reports", "VigiBase IntroductionValproic acid", "characterise valproic acid reports"], "article_id"=>1200570, "categories"=>["Biological Sciences"], "users"=>["Kristina Star", "I. Ralph Edwards", "Imti Choonara"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0108970.t006", "stats"=>{"downloads"=>1, "page_views"=>6, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_The_most_frequently_reported_adverse_reactions_for_valproic_acid_with_fatal_outcome_in_children_/1200570", "title"=>"The most frequently reported adverse reactions for valproic acid with fatal outcome in children.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-10-10 03:05:01"}
  • {"files"=>["https://ndownloader.figshare.com/files/1713181"], "description"=>"<div><p>Introduction</p><p>Valproic acid is an effective first line drug for the treatment of epilepsy. Hepatotoxicity is a rare and potentially fatal adverse reaction for this medicine.</p><p>Objective</p><p>Firstly to characterise valproic acid reports on children with fatal outcome and secondly to determine reporting over time of hepatotoxicity with fatal outcome.</p><p>Methods</p><p>Individual case safety reports (ICSRs) for children ≤17 years with valproic acid and fatal outcome were retrieved from the WHO Global ICSR database, VigiBase, in June 2013. Reports were classified into hepatotoxic reactions or other reactions. Shrinkage observed-to-expected ratios were used to explore the relative reporting trend over time and for patient age. The frequency of polytherapy, i.e. reports with more than one antiepileptic medicine, was investigated.</p><p>Results</p><p>There have been 268 ICSRs with valproic acid and fatal outcome in children, reported from 25 countries since 1977. A total of 156 fatalities were reported with hepatotoxicity, which has been continuously and disproportionally reported over time. There were 31 fatalities with pancreatitis. Other frequently reported events were coma/encephalopathy, seizures, respiratory disorders and coagulopathy. Hepatotoxicity was disproportionally and most commonly reported in children aged 6 years and under (104/156 reports) but affected children of all ages. Polytherapy was significantly more frequently reported for valproic acid with fatal outcome (58%) compared with non-fatal outcome (34%).</p><p>Conclusion</p><p>Hepatotoxicity remains a considerable problem. The risk appears to be greatest in young children (6 years and below) but can occur at any age. Polytherapy is commonly reported and seems to be a risk factor for hepatotoxicity, pancreatitis and other serious adverse drug reactions with valproic acid.</p></div>", "links"=>[], "tags"=>["hepatotoxicity", "Global ICSR database", "outcome.MethodsIndividual case safety reports", "valproic acid", "Individual Case Safety Reports", "June 2013. Reports", "VigiBase IntroductionValproic acid", "characterise valproic acid reports"], "article_id"=>1200571, "categories"=>["Biological Sciences"], "users"=>["Kristina Star", "I. Ralph Edwards", "Imti Choonara"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0108970", "stats"=>{"downloads"=>1, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Valproic_Acid_and_Fatalities_in_Children_A_Review_of_Individual_Case_Safety_Reports_in_VigiBase_/1200571", "title"=>"Valproic Acid and Fatalities in Children: A Review of Individual Case Safety Reports in VigiBase", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-10-10 03:05:01"}

PMC Usage Stats | Further Information

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Relative Metric

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