Surveillance for fatal suspected adverse drug reactions in the UK
Aim: To determine the nature and number of suspected adverse drug reactions (ADRs) associated with fatal outcomes in children reported through the yellow card scheme. Methods: All reports of suspected ADRs with a fatal outcome in children received by the UK Committee on Safety of Medicines through i...
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| Veröffentlicht in: | Archives of disease in childhood 2002-12, Vol.87 (6), p.462-466 |
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| creator | Clarkson, A Choonara, I |
| description | Aim: To determine the nature and number of suspected adverse drug reactions (ADRs) associated with fatal outcomes in children reported through the yellow card scheme. Methods: All reports of suspected ADRs with a fatal outcome in children received by the UK Committee on Safety of Medicines through its Yellow Card Scheme from 1964 until December 2000 were reviewed. Reports associated with vaccines and overdose were excluded. The medicine, date of the report, diagnosis, ADR, and the age of the child were analysed. No formal causality assessment was performed. Results: There were 331 deaths with 390 suspected medicines reported for children aged 16 years or less. Medicines most frequently mentioned were anticonvulsants (65 deaths), cytotoxics (34 deaths), anaesthetic agents (30 deaths), and antibiotics (29 deaths). The individual drug most frequently mentioned was sodium valproate (31 deaths). The nature of the reported ADRs were diverse, with hepatic failure the most frequent. In the past decade, there has been an increase in both the total number of suspected ADRs reported in children and the number of reports with a fatal outcome. Conclusions: A wide range of suspected ADRs are associated with fatalities in children. Anticonvulsants were associated with the greatest number of reports of fatalities and hepatotoxicity in particular. |
| doi_str_mv | 10.1136/adc.87.6.462 |
| format | Article |
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Methods: All reports of suspected ADRs with a fatal outcome in children received by the UK Committee on Safety of Medicines through its Yellow Card Scheme from 1964 until December 2000 were reviewed. Reports associated with vaccines and overdose were excluded. The medicine, date of the report, diagnosis, ADR, and the age of the child were analysed. No formal causality assessment was performed. Results: There were 331 deaths with 390 suspected medicines reported for children aged 16 years or less. Medicines most frequently mentioned were anticonvulsants (65 deaths), cytotoxics (34 deaths), anaesthetic agents (30 deaths), and antibiotics (29 deaths). The individual drug most frequently mentioned was sodium valproate (31 deaths). The nature of the reported ADRs were diverse, with hepatic failure the most frequent. In the past decade, there has been an increase in both the total number of suspected ADRs reported in children and the number of reports with a fatal outcome. Conclusions: A wide range of suspected ADRs are associated with fatalities in children. Anticonvulsants were associated with the greatest number of reports of fatalities and hepatotoxicity in particular.</description><identifier>ISSN: 0003-9888</identifier><identifier>EISSN: 1468-2044</identifier><identifier>DOI: 10.1136/adc.87.6.462</identifier><identifier>PMID: 12456539</identifier><identifier>CODEN: ADCHAK</identifier><language>eng</language><publisher>England: BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health</publisher><subject>ADR ; ADROIT ; Adverse and side effects ; adverse drug reaction ; Adverse drug reactions ; Adverse Drug Reactions On-line Information Tracking ; Age ; Anesthetics - adverse effects ; Anti-Bacterial Agents - adverse effects ; Antibiotics ; Anticonvulsants - adverse effects ; Antineoplastic Agents - adverse effects ; Child ; Children & youth ; Cold remedies ; Death ; drug surveillance ; Drug-Related Side Effects and Adverse Reactions ; Drugs ; Family medical history ; Fatalities ; fatality ; Growth hormones ; Hepatotoxicity ; Humans ; Liver Failure - chemically induced ; MCA ; Medicines Control Agency ; Metabolism ; Mortality ; Narcotics ; Neonates ; non-steroidal anti-inflammatory drug ; NSAID ; Original ; Overdose ; Pediatric pharmacology ; Pharmaceutical industry ; Pharmacists ; Respiratory distress syndrome ; Side effects ; Statistics ; Studies ; Surfactants ; surveillance ; Toxicity ; United Kingdom - epidemiology ; Valproic Acid - adverse effects ; YCS ; Yellow Card Scheme ; Young Children</subject><ispartof>Archives of disease in childhood, 2002-12, Vol.87 (6), p.462-466</ispartof><rights>Copyright 2002 Archives of Disease in Childhood</rights><rights>COPYRIGHT 2002 BMJ Publishing Group Ltd.</rights><rights>COPYRIGHT 2002 BMJ Publishing Group Ltd.</rights><rights>Copyright: 2002 Copyright 2002 Archives of Disease in Childhood</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b654t-ac1ea7cd7904dce05f4eabb0547c155570f61ff1e67b167dc08da849d62f9a4e3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC1755830/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC1755830/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12456539$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Clarkson, A</creatorcontrib><creatorcontrib>Choonara, I</creatorcontrib><title>Surveillance for fatal suspected adverse drug reactions in the UK</title><title>Archives of disease in childhood</title><addtitle>Arch Dis Child</addtitle><description>Aim: To determine the nature and number of suspected adverse drug reactions (ADRs) associated with fatal outcomes in children reported through the yellow card scheme. Methods: All reports of suspected ADRs with a fatal outcome in children received by the UK Committee on Safety of Medicines through its Yellow Card Scheme from 1964 until December 2000 were reviewed. Reports associated with vaccines and overdose were excluded. The medicine, date of the report, diagnosis, ADR, and the age of the child were analysed. No formal causality assessment was performed. Results: There were 331 deaths with 390 suspected medicines reported for children aged 16 years or less. Medicines most frequently mentioned were anticonvulsants (65 deaths), cytotoxics (34 deaths), anaesthetic agents (30 deaths), and antibiotics (29 deaths). The individual drug most frequently mentioned was sodium valproate (31 deaths). The nature of the reported ADRs were diverse, with hepatic failure the most frequent. In the past decade, there has been an increase in both the total number of suspected ADRs reported in children and the number of reports with a fatal outcome. Conclusions: A wide range of suspected ADRs are associated with fatalities in children. Anticonvulsants were associated with the greatest number of reports of fatalities and hepatotoxicity in particular.</description><subject>ADR</subject><subject>ADROIT</subject><subject>Adverse and side effects</subject><subject>adverse drug reaction</subject><subject>Adverse drug reactions</subject><subject>Adverse Drug Reactions On-line Information Tracking</subject><subject>Age</subject><subject>Anesthetics - adverse effects</subject><subject>Anti-Bacterial Agents - adverse effects</subject><subject>Antibiotics</subject><subject>Anticonvulsants - adverse effects</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Child</subject><subject>Children & youth</subject><subject>Cold remedies</subject><subject>Death</subject><subject>drug surveillance</subject><subject>Drug-Related Side Effects and Adverse Reactions</subject><subject>Drugs</subject><subject>Family medical history</subject><subject>Fatalities</subject><subject>fatality</subject><subject>Growth hormones</subject><subject>Hepatotoxicity</subject><subject>Humans</subject><subject>Liver Failure - chemically induced</subject><subject>MCA</subject><subject>Medicines Control Agency</subject><subject>Metabolism</subject><subject>Mortality</subject><subject>Narcotics</subject><subject>Neonates</subject><subject>non-steroidal anti-inflammatory drug</subject><subject>NSAID</subject><subject>Original</subject><subject>Overdose</subject><subject>Pediatric pharmacology</subject><subject>Pharmaceutical industry</subject><subject>Pharmacists</subject><subject>Respiratory distress syndrome</subject><subject>Side effects</subject><subject>Statistics</subject><subject>Studies</subject><subject>Surfactants</subject><subject>surveillance</subject><subject>Toxicity</subject><subject>United Kingdom - epidemiology</subject><subject>Valproic Acid - adverse effects</subject><subject>YCS</subject><subject>Yellow Card Scheme</subject><subject>Young Children</subject><issn>0003-9888</issn><issn>1468-2044</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp9ks9v0zAcxSMEYmVw44wiIQGHpdiJf-UyqYrGYJTtMMaOluN8nbmkcbGTavz3uGq1UVQhHyz5-9F7el-_JHmN0RTjgn1UjZ4KPmVTwvInyQQTJrIcEfI0mSCEiqwUQhwlL0JYIIRzIYrnyRHOCWW0KCfJ7Hr0a7Bdp3oNqXE-NWpQXRrGsAI9QJOqZg0-QNr4sU09KD1Y14fU9ulwB-nN15fJM6O6AK9293Fy8-nse_U5m1-df6lm86xmlAyZ0hgU1w0vEWk0IGoIqLpGlHCNKaUcGYaNwcB4jRlvNBKNEqRsWG5KRaA4Tk63uquxXkKU6AevOrnydqn8b-mUlfuT3t7J1q0l5pSKAkWBdzsB736NEAa5tEHDJjq4MUhc5gQxsgHf_gMu3Oj7GC5qcYEEpqKM1MmWalUH0vbGRVfdQg_R3PVgbHyelTEZpngjmh3A42lgafUh_sMeH5EB7odWjSFIcT7fQ08Oodp1HbQg4y9UV4dw7V0IHszDDjGSm0rJWCkpuGQyVirib_7e-yO869BjMhui7cNc-Z-S8YJTefmjkhffquvb24tKXkb-_Zavl4v_W_8BGiPhQA</recordid><startdate>200212</startdate><enddate>200212</enddate><creator>Clarkson, A</creator><creator>Choonara, I</creator><general>BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health</general><general>BMJ Publishing Group Ltd</general><general>BMJ Publishing Group LTD</general><scope>BSCLL</scope><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>8GL</scope><scope>0-V</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88B</scope><scope>88E</scope><scope>88I</scope><scope>8A4</scope><scope>8AF</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>ALSLI</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>CJNVE</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>LK8</scope><scope>M0P</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2P</scope><scope>M7P</scope><scope>PQEDU</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7U7</scope><scope>C1K</scope><scope>5PM</scope></search><sort><creationdate>200212</creationdate><title>Surveillance for fatal suspected adverse drug reactions in the UK</title><author>Clarkson, A ; Choonara, I</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b654t-ac1ea7cd7904dce05f4eabb0547c155570f61ff1e67b167dc08da849d62f9a4e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>ADR</topic><topic>ADROIT</topic><topic>Adverse and side effects</topic><topic>adverse drug reaction</topic><topic>Adverse drug reactions</topic><topic>Adverse Drug Reactions On-line Information Tracking</topic><topic>Age</topic><topic>Anesthetics - adverse effects</topic><topic>Anti-Bacterial Agents - adverse effects</topic><topic>Antibiotics</topic><topic>Anticonvulsants - adverse effects</topic><topic>Antineoplastic Agents - adverse effects</topic><topic>Child</topic><topic>Children & youth</topic><topic>Cold remedies</topic><topic>Death</topic><topic>drug surveillance</topic><topic>Drug-Related Side Effects and Adverse Reactions</topic><topic>Drugs</topic><topic>Family medical history</topic><topic>Fatalities</topic><topic>fatality</topic><topic>Growth hormones</topic><topic>Hepatotoxicity</topic><topic>Humans</topic><topic>Liver Failure - chemically induced</topic><topic>MCA</topic><topic>Medicines Control Agency</topic><topic>Metabolism</topic><topic>Mortality</topic><topic>Narcotics</topic><topic>Neonates</topic><topic>non-steroidal anti-inflammatory drug</topic><topic>NSAID</topic><topic>Original</topic><topic>Overdose</topic><topic>Pediatric pharmacology</topic><topic>Pharmaceutical industry</topic><topic>Pharmacists</topic><topic>Respiratory distress syndrome</topic><topic>Side effects</topic><topic>Statistics</topic><topic>Studies</topic><topic>Surfactants</topic><topic>surveillance</topic><topic>Toxicity</topic><topic>United Kingdom - epidemiology</topic><topic>Valproic Acid - adverse effects</topic><topic>YCS</topic><topic>Yellow Card Scheme</topic><topic>Young Children</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Clarkson, A</creatorcontrib><creatorcontrib>Choonara, I</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Gale In Context: High School</collection><collection>ProQuest Social Sciences Premium Collection【Remote access available】</collection><collection>ProQuest Central (Corporate)</collection><collection>ProQuest Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Education Database (Alumni Edition)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>Education Periodicals</collection><collection>STEM Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</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)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>Social Science Premium Collection (Proquest) (PQ_SDU_P3)</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>ProQuest Natural Science Collection</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>Education Collection (Proquest) (PQ_SDU_P3)</collection><collection>ProQuest Central</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Biological Sciences</collection><collection>ProQuest Education Journals</collection><collection>Family Health Database (Proquest)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Science Database (ProQuest)</collection><collection>Biological Science Database</collection><collection>ProQuest One Education</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 Basic</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Archives of disease in childhood</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Clarkson, A</au><au>Choonara, I</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Surveillance for fatal suspected adverse drug reactions in the UK</atitle><jtitle>Archives of disease in childhood</jtitle><addtitle>Arch Dis Child</addtitle><date>2002-12</date><risdate>2002</risdate><volume>87</volume><issue>6</issue><spage>462</spage><epage>466</epage><pages>462-466</pages><issn>0003-9888</issn><eissn>1468-2044</eissn><coden>ADCHAK</coden><abstract>Aim: To determine the nature and number of suspected adverse drug reactions (ADRs) associated with fatal outcomes in children reported through the yellow card scheme. Methods: All reports of suspected ADRs with a fatal outcome in children received by the UK Committee on Safety of Medicines through its Yellow Card Scheme from 1964 until December 2000 were reviewed. Reports associated with vaccines and overdose were excluded. The medicine, date of the report, diagnosis, ADR, and the age of the child were analysed. No formal causality assessment was performed. Results: There were 331 deaths with 390 suspected medicines reported for children aged 16 years or less. Medicines most frequently mentioned were anticonvulsants (65 deaths), cytotoxics (34 deaths), anaesthetic agents (30 deaths), and antibiotics (29 deaths). The individual drug most frequently mentioned was sodium valproate (31 deaths). The nature of the reported ADRs were diverse, with hepatic failure the most frequent. In the past decade, there has been an increase in both the total number of suspected ADRs reported in children and the number of reports with a fatal outcome. Conclusions: A wide range of suspected ADRs are associated with fatalities in children. Anticonvulsants were associated with the greatest number of reports of fatalities and hepatotoxicity in particular.</abstract><cop>England</cop><pub>BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health</pub><pmid>12456539</pmid><doi>10.1136/adc.87.6.462</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Archives of disease in childhood, 2002-12, Vol.87 (6), p.462-466 |
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| source | MEDLINE; PubMed Central; Alma/SFX Local Collection; EZB Electronic Journals Library |
| subjects | ADR ADROIT Adverse and side effects adverse drug reaction Adverse drug reactions Adverse Drug Reactions On-line Information Tracking Age Anesthetics - adverse effects Anti-Bacterial Agents - adverse effects Antibiotics Anticonvulsants - adverse effects Antineoplastic Agents - adverse effects Child Children & youth Cold remedies Death drug surveillance Drug-Related Side Effects and Adverse Reactions Drugs Family medical history Fatalities fatality Growth hormones Hepatotoxicity Humans Liver Failure - chemically induced MCA Medicines Control Agency Metabolism Mortality Narcotics Neonates non-steroidal anti-inflammatory drug NSAID Original Overdose Pediatric pharmacology Pharmaceutical industry Pharmacists Respiratory distress syndrome Side effects Statistics Studies Surfactants surveillance Toxicity United Kingdom - epidemiology Valproic Acid - adverse effects YCS Yellow Card Scheme Young Children |
| title | Surveillance for fatal suspected adverse drug reactions in the UK |
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