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 |
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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 |
doi_str_mv | 10.1007/s40264-016-0429-6 |
format | Article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1827883744</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>4190098891</sourcerecordid><originalsourceid>FETCH-LOGICAL-c405t-772d525174be8682c163737cc3fd278dda0486aa9ea45e5a37ec493ffbfc42d53</originalsourceid><addsrcrecordid>eNp1kcFqFTEUhoNY7LX6AG4k4MZNbJLJJDPuhkvVQkFodeEq5CZnNGUmc5uTQPv2ncutIoKrLM73_yecj5A3gn8QnJtzVFxqxbjQjCvZM_2MbIQwPRO9ks_JhguhWNsLfUpeIt5yzjupuxfkVBrJtZF6Q8qQC2BNrsD5MC8hursaE7DLFKqHQAdfC9CL-5Ld_iG7OQY30WtwvsQlIY2Jbn_FKWRI1KVAfyw1_YRMh1Cngh_p1iHQG8gRkA6IgDhDKq_IyegmhNdP7xn5_uni2_YLu_r6-XI7XDGveFuYMTK0shVG7aDTnfRCN6Yx3jdjkKYLwXHVaed6cKqF1jUGvOqbcdyNXq3R5oy8P_bu83JXAYudI3qYJpdgqWhFt9Z0jVFqRd_9g94uNaf1dwdK8r7hvVwpcaR8XhAzjHaf4-zygxXcHpTYoxK7KrEHJVavmbdPzXU3Q_iT-O1gBeQRwHV0uN5fq__b-gjLmZcv</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1822093092</pqid></control><display><type>article</type><title>Artesunate/Amodiaquine-Induced Acute Extrapyramidal Reactions in Children and Younger Adults: Case Series Assessment</title><source>MEDLINE</source><source>SpringerLink Journals</source><creator>Russom, Mulugeta ; Tesfai, Dawit ; Gebregiorgis, Semere ; Usman, Abdulmumini ; Mihreteab, Selam ; Bahta, Iyassu ; Mekonnen, Elsa ; Ghebrehiwet, Selamawit ; Abrham, Gelila</creator><creatorcontrib>Russom, Mulugeta ; Tesfai, Dawit ; Gebregiorgis, Semere ; Usman, Abdulmumini ; Mihreteab, Selam ; Bahta, Iyassu ; Mekonnen, Elsa ; Ghebrehiwet, Selamawit ; Abrham, Gelila</creatorcontrib><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 <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 & 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</subject><ispartof>Drug safety, 2016-08, Vol.39 (8), p.763-768</ispartof><rights>Springer International Publishing Switzerland 2016</rights><rights>Copyright Springer Science & 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 <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 & dosage</subject><subject>Amodiaquine - adverse effects</subject><subject>Antimalarials - administration & dosage</subject><subject>Antimalarials - adverse effects</subject><subject>Artemisinins - administration & 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 & numerical data</subject><subject>Humans</subject><subject>Malaria</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Original Research Article</subject><subject>Pharmaceutical industry</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacovigilance</subject><subject>Side effects</subject><subject>Studies</subject><subject>Time Factors</subject><subject>Young Adult</subject><issn>0114-5916</issn><issn>1179-1942</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1kcFqFTEUhoNY7LX6AG4k4MZNbJLJJDPuhkvVQkFodeEq5CZnNGUmc5uTQPv2ncutIoKrLM73_yecj5A3gn8QnJtzVFxqxbjQjCvZM_2MbIQwPRO9ks_JhguhWNsLfUpeIt5yzjupuxfkVBrJtZF6Q8qQC2BNrsD5MC8hursaE7DLFKqHQAdfC9CL-5Ld_iG7OQY30WtwvsQlIY2Jbn_FKWRI1KVAfyw1_YRMh1Cngh_p1iHQG8gRkA6IgDhDKq_IyegmhNdP7xn5_uni2_YLu_r6-XI7XDGveFuYMTK0shVG7aDTnfRCN6Yx3jdjkKYLwXHVaed6cKqF1jUGvOqbcdyNXq3R5oy8P_bu83JXAYudI3qYJpdgqWhFt9Z0jVFqRd_9g94uNaf1dwdK8r7hvVwpcaR8XhAzjHaf4-zygxXcHpTYoxK7KrEHJVavmbdPzXU3Q_iT-O1gBeQRwHV0uN5fq__b-gjLmZcv</recordid><startdate>20160801</startdate><enddate>20160801</enddate><creator>Russom, Mulugeta</creator><creator>Tesfai, Dawit</creator><creator>Gebregiorgis, Semere</creator><creator>Usman, Abdulmumini</creator><creator>Mihreteab, Selam</creator><creator>Bahta, Iyassu</creator><creator>Mekonnen, Elsa</creator><creator>Ghebrehiwet, Selamawit</creator><creator>Abrham, Gelila</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>4T-</scope><scope>7RV</scope><scope>7T2</scope><scope>7TK</scope><scope>7U7</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7U2</scope></search><sort><creationdate>20160801</creationdate><title>Artesunate/Amodiaquine-Induced Acute Extrapyramidal Reactions in Children and Younger Adults: Case Series Assessment</title><author>Russom, Mulugeta ; 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 & dosage</topic><topic>Amodiaquine - adverse effects</topic><topic>Antimalarials - administration & dosage</topic><topic>Antimalarials - adverse effects</topic><topic>Artemisinins - administration & 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 & numerical data</topic><topic>Humans</topic><topic>Malaria</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & 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 & Allied Health Database</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Safety Science and Risk</collection><jtitle>Drug safety</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Russom, Mulugeta</au><au>Tesfai, Dawit</au><au>Gebregiorgis, Semere</au><au>Usman, Abdulmumini</au><au>Mihreteab, Selam</au><au>Bahta, Iyassu</au><au>Mekonnen, Elsa</au><au>Ghebrehiwet, Selamawit</au><au>Abrham, Gelila</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Artesunate/Amodiaquine-Induced Acute Extrapyramidal Reactions in Children and Younger Adults: Case Series Assessment</atitle><jtitle>Drug safety</jtitle><stitle>Drug Saf</stitle><addtitle>Drug Saf</addtitle><date>2016-08-01</date><risdate>2016</risdate><volume>39</volume><issue>8</issue><spage>763</spage><epage>768</epage><pages>763-768</pages><issn>0114-5916</issn><eissn>1179-1942</eissn><abstract>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 <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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