Artesunate/Amodiaquine-Induced Acute Extrapyramidal Reactions in Children and Younger Adults: Case Series Assessment

Introduction Several studies conducted in African countries reported the artesunate and amodiaquine (AS/AQ) tablet as a safe and well-tolerated anti-malarial drug in children and younger adults. The aim of this case series assessment was to assess the causal relationship between the AS/AQ tablet and...

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Veröffentlicht in:Drug safety 2016-08, Vol.39 (8), p.763-768
Hauptverfasser: Russom, Mulugeta, Tesfai, Dawit, Gebregiorgis, Semere, Usman, Abdulmumini, Mihreteab, Selam, Bahta, Iyassu, Mekonnen, Elsa, Ghebrehiwet, Selamawit, Abrham, Gelila
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container_title Drug safety
container_volume 39
creator Russom, Mulugeta
Tesfai, Dawit
Gebregiorgis, Semere
Usman, Abdulmumini
Mihreteab, Selam
Bahta, Iyassu
Mekonnen, Elsa
Ghebrehiwet, Selamawit
Abrham, Gelila
description Introduction Several studies conducted in African countries reported the artesunate and amodiaquine (AS/AQ) tablet as a safe and well-tolerated anti-malarial drug in children and younger adults. The aim of this case series assessment was to assess the causal relationship between the AS/AQ tablet and extrapyramidal reactions in children and younger adults and to investigate the factor(s) predisposing to the adverse drug reactions. Methods The causal relationship of all the cases was first assessed individually using the Naranjo Probability Scale and then subjected to a case series assessment using Austin Bradford–Hill criteria. Results A total of 43 acute extrapyramidal reactions associated with the AS/AQ tablet were reported between 2012 and 16 November, 2015 to the Eritrean Pharmacovigilance Centre. The causality was found to be probable or highly probable for 33 (76.7 %) of the cases and the rest (10; 23.3 %) of the cases had a possible causal association. The extrapyramidal reactions had more or less similar clinical features in most of the cases and were characterized by abnormal involuntary contractions of muscles. The median age and body weight of the cases were 15 years and 40 kg, respectively, and 70 % of them were males. 90.7% of the reactions manifested in children and younger adults (aged
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The aim of this case series assessment was to assess the causal relationship between the AS/AQ tablet and extrapyramidal reactions in children and younger adults and to investigate the factor(s) predisposing to the adverse drug reactions. Methods The causal relationship of all the cases was first assessed individually using the Naranjo Probability Scale and then subjected to a case series assessment using Austin Bradford–Hill criteria. Results A total of 43 acute extrapyramidal reactions associated with the AS/AQ tablet were reported between 2012 and 16 November, 2015 to the Eritrean Pharmacovigilance Centre. The causality was found to be probable or highly probable for 33 (76.7 %) of the cases and the rest (10; 23.3 %) of the cases had a possible causal association. The extrapyramidal reactions had more or less similar clinical features in most of the cases and were characterized by abnormal involuntary contractions of muscles. The median age and body weight of the cases were 15 years and 40 kg, respectively, and 70 % of them were males. 90.7% of the reactions manifested in children and younger adults (aged &lt;26 years). In most of the cases, reactions manifested in the third day from the start of treatment and 88.3 % of cases were hospitalized. Conclusion The causal relationship between the AS/AQ tablet and extrapyramidal reactions in children and younger adults was found to be apparent and possibly owing to dose accumulation or an overdose of amodiaquine.</description><identifier>ISSN: 0114-5916</identifier><identifier>EISSN: 1179-1942</identifier><identifier>DOI: 10.1007/s40264-016-0429-6</identifier><identifier>PMID: 27206726</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Adolescent ; Adult ; Age ; Age Factors ; Amodiaquine - administration &amp; dosage ; Amodiaquine - adverse effects ; Antimalarials - administration &amp; dosage ; Antimalarials - adverse effects ; Artemisinins - administration &amp; dosage ; Artemisinins - adverse effects ; Basal Ganglia Diseases - chemically induced ; Basal Ganglia Diseases - physiopathology ; Child ; Dopamine ; Dose-Response Relationship, Drug ; Drug Combinations ; Drug dosages ; Drug Overdose - epidemiology ; Drug Safety and Pharmacovigilance ; Female ; Funding ; Hospitalization - statistics &amp; numerical data ; Humans ; Malaria ; Male ; Medicine ; Medicine &amp; Public Health ; Middle Aged ; Original Research Article ; Pharmaceutical industry ; Pharmacology/Toxicology ; Pharmacovigilance ; Side effects ; Studies ; Time Factors ; Young Adult</subject><ispartof>Drug safety, 2016-08, Vol.39 (8), p.763-768</ispartof><rights>Springer International Publishing Switzerland 2016</rights><rights>Copyright Springer Science &amp; Business Media Aug 2016</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c405t-772d525174be8682c163737cc3fd278dda0486aa9ea45e5a37ec493ffbfc42d53</citedby><cites>FETCH-LOGICAL-c405t-772d525174be8682c163737cc3fd278dda0486aa9ea45e5a37ec493ffbfc42d53</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s40264-016-0429-6$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s40264-016-0429-6$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27206726$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Russom, Mulugeta</creatorcontrib><creatorcontrib>Tesfai, Dawit</creatorcontrib><creatorcontrib>Gebregiorgis, Semere</creatorcontrib><creatorcontrib>Usman, Abdulmumini</creatorcontrib><creatorcontrib>Mihreteab, Selam</creatorcontrib><creatorcontrib>Bahta, Iyassu</creatorcontrib><creatorcontrib>Mekonnen, Elsa</creatorcontrib><creatorcontrib>Ghebrehiwet, Selamawit</creatorcontrib><creatorcontrib>Abrham, Gelila</creatorcontrib><title>Artesunate/Amodiaquine-Induced Acute Extrapyramidal Reactions in Children and Younger Adults: Case Series Assessment</title><title>Drug safety</title><addtitle>Drug Saf</addtitle><addtitle>Drug Saf</addtitle><description>Introduction Several studies conducted in African countries reported the artesunate and amodiaquine (AS/AQ) tablet as a safe and well-tolerated anti-malarial drug in children and younger adults. The aim of this case series assessment was to assess the causal relationship between the AS/AQ tablet and extrapyramidal reactions in children and younger adults and to investigate the factor(s) predisposing to the adverse drug reactions. Methods The causal relationship of all the cases was first assessed individually using the Naranjo Probability Scale and then subjected to a case series assessment using Austin Bradford–Hill criteria. Results A total of 43 acute extrapyramidal reactions associated with the AS/AQ tablet were reported between 2012 and 16 November, 2015 to the Eritrean Pharmacovigilance Centre. The causality was found to be probable or highly probable for 33 (76.7 %) of the cases and the rest (10; 23.3 %) of the cases had a possible causal association. The extrapyramidal reactions had more or less similar clinical features in most of the cases and were characterized by abnormal involuntary contractions of muscles. The median age and body weight of the cases were 15 years and 40 kg, respectively, and 70 % of them were males. 90.7% of the reactions manifested in children and younger adults (aged &lt;26 years). In most of the cases, reactions manifested in the third day from the start of treatment and 88.3 % of cases were hospitalized. Conclusion The causal relationship between the AS/AQ tablet and extrapyramidal reactions in children and younger adults was found to be apparent and possibly owing to dose accumulation or an overdose of amodiaquine.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Age</subject><subject>Age Factors</subject><subject>Amodiaquine - administration &amp; dosage</subject><subject>Amodiaquine - adverse effects</subject><subject>Antimalarials - administration &amp; dosage</subject><subject>Antimalarials - adverse effects</subject><subject>Artemisinins - administration &amp; dosage</subject><subject>Artemisinins - adverse effects</subject><subject>Basal Ganglia Diseases - chemically induced</subject><subject>Basal Ganglia Diseases - physiopathology</subject><subject>Child</subject><subject>Dopamine</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Combinations</subject><subject>Drug dosages</subject><subject>Drug Overdose - epidemiology</subject><subject>Drug Safety and Pharmacovigilance</subject><subject>Female</subject><subject>Funding</subject><subject>Hospitalization - statistics &amp; 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Tesfai, Dawit ; Gebregiorgis, Semere ; Usman, Abdulmumini ; Mihreteab, Selam ; Bahta, Iyassu ; Mekonnen, Elsa ; Ghebrehiwet, Selamawit ; Abrham, Gelila</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c405t-772d525174be8682c163737cc3fd278dda0486aa9ea45e5a37ec493ffbfc42d53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Age</topic><topic>Age Factors</topic><topic>Amodiaquine - administration &amp; dosage</topic><topic>Amodiaquine - adverse effects</topic><topic>Antimalarials - administration &amp; dosage</topic><topic>Antimalarials - adverse effects</topic><topic>Artemisinins - administration &amp; dosage</topic><topic>Artemisinins - adverse effects</topic><topic>Basal Ganglia Diseases - chemically induced</topic><topic>Basal Ganglia Diseases - physiopathology</topic><topic>Child</topic><topic>Dopamine</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Combinations</topic><topic>Drug dosages</topic><topic>Drug Overdose - epidemiology</topic><topic>Drug Safety and Pharmacovigilance</topic><topic>Female</topic><topic>Funding</topic><topic>Hospitalization - statistics &amp; numerical data</topic><topic>Humans</topic><topic>Malaria</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Middle Aged</topic><topic>Original Research Article</topic><topic>Pharmaceutical industry</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacovigilance</topic><topic>Side effects</topic><topic>Studies</topic><topic>Time Factors</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Russom, Mulugeta</creatorcontrib><creatorcontrib>Tesfai, Dawit</creatorcontrib><creatorcontrib>Gebregiorgis, Semere</creatorcontrib><creatorcontrib>Usman, Abdulmumini</creatorcontrib><creatorcontrib>Mihreteab, Selam</creatorcontrib><creatorcontrib>Bahta, Iyassu</creatorcontrib><creatorcontrib>Mekonnen, Elsa</creatorcontrib><creatorcontrib>Ghebrehiwet, Selamawit</creatorcontrib><creatorcontrib>Abrham, Gelila</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Docstoc</collection><collection>Nursing &amp; 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The aim of this case series assessment was to assess the causal relationship between the AS/AQ tablet and extrapyramidal reactions in children and younger adults and to investigate the factor(s) predisposing to the adverse drug reactions. Methods The causal relationship of all the cases was first assessed individually using the Naranjo Probability Scale and then subjected to a case series assessment using Austin Bradford–Hill criteria. Results A total of 43 acute extrapyramidal reactions associated with the AS/AQ tablet were reported between 2012 and 16 November, 2015 to the Eritrean Pharmacovigilance Centre. The causality was found to be probable or highly probable for 33 (76.7 %) of the cases and the rest (10; 23.3 %) of the cases had a possible causal association. The extrapyramidal reactions had more or less similar clinical features in most of the cases and were characterized by abnormal involuntary contractions of muscles. The median age and body weight of the cases were 15 years and 40 kg, respectively, and 70 % of them were males. 90.7% of the reactions manifested in children and younger adults (aged &lt;26 years). In most of the cases, reactions manifested in the third day from the start of treatment and 88.3 % of cases were hospitalized. Conclusion The causal relationship between the AS/AQ tablet and extrapyramidal reactions in children and younger adults was found to be apparent and possibly owing to dose accumulation or an overdose of amodiaquine.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>27206726</pmid><doi>10.1007/s40264-016-0429-6</doi><tpages>6</tpages></addata></record>
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subjects Adolescent
Adult
Age
Age Factors
Amodiaquine - administration & dosage
Amodiaquine - adverse effects
Antimalarials - administration & dosage
Antimalarials - adverse effects
Artemisinins - administration & dosage
Artemisinins - adverse effects
Basal Ganglia Diseases - chemically induced
Basal Ganglia Diseases - physiopathology
Child
Dopamine
Dose-Response Relationship, Drug
Drug Combinations
Drug dosages
Drug Overdose - epidemiology
Drug Safety and Pharmacovigilance
Female
Funding
Hospitalization - statistics & numerical data
Humans
Malaria
Male
Medicine
Medicine & Public Health
Middle Aged
Original Research Article
Pharmaceutical industry
Pharmacology/Toxicology
Pharmacovigilance
Side effects
Studies
Time Factors
Young Adult
title Artesunate/Amodiaquine-Induced Acute Extrapyramidal Reactions in Children and Younger Adults: Case Series Assessment
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