Loading…

Adverse drug reactions and off-label drug use in paediatric outpatients

To investigate the potential relationship between off-label drug use and increased risk of adverse drug reactions in paediatric outpatients. A prospective pharmacovigilance survey of drug prescribing in office based paediatricians was carried out in Haute-Garonne County (south west of France). The s...

Full description

Saved in:

Bibliographic Details
Published in:	British journal of clinical pharmacology 2002-12, Vol.54 (6), p.665-670
Main Authors:	HOREN, Benjamin, MONTASTRUC, Jean-Louis, LAPEYRE-MESTRE, Maryse
Format:	Article
Language:	English
Subjects:	Adolescent Biological and medical sciences Child Child, Preschool Drug Labeling Drug Prescriptions Drug toxicity and drugs side effects treatment Drug-Related Side Effects and Adverse Reactions Female France Humans Infant Infant, Newborn Male Medical sciences Miscellaneous (drug allergy, mutagens, teratogens...) Outpatients Pediatrics - methods Pharmacology. Drug treatments Prospective Studies Short Reports
Citations:	Items that this one cites Items that cite this one
Online Access:	Get full text
Tags:	Add Tag No Tags, Be the first to tag this record!

cited_by	cdi_FETCH-LOGICAL-c464t-49021e66d8b987ed858fee76b526dfc121003c30e21f76137bc8b4b8267163a33
cites	cdi_FETCH-LOGICAL-c464t-49021e66d8b987ed858fee76b526dfc121003c30e21f76137bc8b4b8267163a33
container_end_page	670
container_issue	6
container_start_page	665
container_title	British journal of clinical pharmacology
container_volume	54
creator	HOREN, Benjamin MONTASTRUC, Jean-Louis LAPEYRE-MESTRE, Maryse
description	To investigate the potential relationship between off-label drug use and increased risk of adverse drug reactions in paediatric outpatients. A prospective pharmacovigilance survey of drug prescribing in office based paediatricians was carried out in Haute-Garonne County (south west of France). The study involved a sample of 1419 children under 16 years old. Forty-two percent of patients were exposed to at least one off-label prescription. The incidence of adverse drug reactions was 1.41% (95% CI 0.79, 2.11). Off-label drug use was significantly associated with adverse drug reactions (relative risk 3.44; 95% CI 1.26, 9.38), particularly when it was due to an indication different than that defined in the Summary Product Characteristics (relative risk 4.42; 95% CI 1.60, 12.25). Our data suggest an increasing risk of adverse drug reactions related to off-label drug use. This risk would be acceptable if further studies prove the potential benefit of such a drug use.
doi_str_mv	10.1046/j.1365-2125.2002.t01-3-01689.x
format	article
fullrecord	<record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_1874497</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>72782032</sourcerecordid><originalsourceid>FETCH-LOGICAL-c464t-49021e66d8b987ed858fee76b526dfc121003c30e21f76137bc8b4b8267163a33</originalsourceid><addsrcrecordid>eNpVkc1u2zAQhImiQe0kfYVCl-YmdZekSOpSwAjyU8BAL8mZoKhVSkOWXFIykrePnBhxe-Jhvp0hZhi7QigQpPqxKVCoMufIy4ID8GIEzEUOqExVPH9iyw_5M1uCAJWXvMQFO09pA4ACVfmFLZDLiitUS3a3avYUE2VNnJ6ySM6PYehT5vomG9o271xN3bs4zVTos52jJrgxBp8N07hzY6B-TJfsrHVdoq_H94I93t48XN_n6993v65X69xLJcdcVsCRlGpMXRlNjSlNS6RVXXLVtB45AggvgDi2WqHQtTe1rA1XGpVwQlywn---u6neUuPn7Og6u4th6-KLHVyw_yt9-GOfhr1Fo6Ws9GxwdTSIw9-J0mi3IXnqOtfTMCWruTYcBD8l-TikFKn9CEGwhy3sxh7Ktoey7WELO29hhX3bwj7PBt_-_erp_Fj-DHw_Ai5517XR9T6kEyclmMpU4hU1o5SK</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>72782032</pqid></control><display><type>article</type><title>Adverse drug reactions and off-label drug use in paediatric outpatients</title><source>Wiley-Blackwell Read & Publish Collection</source><creator>HOREN, Benjamin ; MONTASTRUC, Jean-Louis ; LAPEYRE-MESTRE, Maryse</creator><creatorcontrib>HOREN, Benjamin ; MONTASTRUC, Jean-Louis ; LAPEYRE-MESTRE, Maryse</creatorcontrib><description>To investigate the potential relationship between off-label drug use and increased risk of adverse drug reactions in paediatric outpatients. A prospective pharmacovigilance survey of drug prescribing in office based paediatricians was carried out in Haute-Garonne County (south west of France). The study involved a sample of 1419 children under 16 years old. Forty-two percent of patients were exposed to at least one off-label prescription. The incidence of adverse drug reactions was 1.41% (95% CI 0.79, 2.11). Off-label drug use was significantly associated with adverse drug reactions (relative risk 3.44; 95% CI 1.26, 9.38), particularly when it was due to an indication different than that defined in the Summary Product Characteristics (relative risk 4.42; 95% CI 1.60, 12.25). Our data suggest an increasing risk of adverse drug reactions related to off-label drug use. This risk would be acceptable if further studies prove the potential benefit of such a drug use.</description><identifier>ISSN: 0306-5251</identifier><identifier>EISSN: 1365-2125</identifier><identifier>DOI: 10.1046/j.1365-2125.2002.t01-3-01689.x</identifier><identifier>PMID: 12492616</identifier><identifier>CODEN: BCPHBM</identifier><language>eng</language><publisher>London: Blackwell Science</publisher><subject>Adolescent ; Biological and medical sciences ; Child ; Child, Preschool ; Drug Labeling ; Drug Prescriptions ; Drug toxicity and drugs side effects treatment ; Drug-Related Side Effects and Adverse Reactions ; Female ; France ; Humans ; Infant ; Infant, Newborn ; Male ; Medical sciences ; Miscellaneous (drug allergy, mutagens, teratogens...) ; Outpatients ; Pediatrics - methods ; Pharmacology. Drug treatments ; Prospective Studies ; Short Reports</subject><ispartof>British journal of clinical pharmacology, 2002-12, Vol.54 (6), p.665-670</ispartof><rights>2003 INIST-CNRS</rights><rights>2002 Blackwell Science Ltd 2002</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c464t-49021e66d8b987ed858fee76b526dfc121003c30e21f76137bc8b4b8267163a33</citedby><cites>FETCH-LOGICAL-c464t-49021e66d8b987ed858fee76b526dfc121003c30e21f76137bc8b4b8267163a33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,777,781,882,27905,27906</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=14408989$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12492616$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>HOREN, Benjamin</creatorcontrib><creatorcontrib>MONTASTRUC, Jean-Louis</creatorcontrib><creatorcontrib>LAPEYRE-MESTRE, Maryse</creatorcontrib><title>Adverse drug reactions and off-label drug use in paediatric outpatients</title><title>British journal of clinical pharmacology</title><addtitle>Br J Clin Pharmacol</addtitle><description>To investigate the potential relationship between off-label drug use and increased risk of adverse drug reactions in paediatric outpatients. A prospective pharmacovigilance survey of drug prescribing in office based paediatricians was carried out in Haute-Garonne County (south west of France). The study involved a sample of 1419 children under 16 years old. Forty-two percent of patients were exposed to at least one off-label prescription. The incidence of adverse drug reactions was 1.41% (95% CI 0.79, 2.11). Off-label drug use was significantly associated with adverse drug reactions (relative risk 3.44; 95% CI 1.26, 9.38), particularly when it was due to an indication different than that defined in the Summary Product Characteristics (relative risk 4.42; 95% CI 1.60, 12.25). Our data suggest an increasing risk of adverse drug reactions related to off-label drug use. This risk would be acceptable if further studies prove the potential benefit of such a drug use.</description><subject>Adolescent</subject><subject>Biological and medical sciences</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Drug Labeling</subject><subject>Drug Prescriptions</subject><subject>Drug toxicity and drugs side effects treatment</subject><subject>Drug-Related Side Effects and Adverse Reactions</subject><subject>Female</subject><subject>France</subject><subject>Humans</subject><subject>Infant</subject><subject>Infant, Newborn</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Miscellaneous (drug allergy, mutagens, teratogens...)</subject><subject>Outpatients</subject><subject>Pediatrics - methods</subject><subject>Pharmacology. Drug treatments</subject><subject>Prospective Studies</subject><subject>Short Reports</subject><issn>0306-5251</issn><issn>1365-2125</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><recordid>eNpVkc1u2zAQhImiQe0kfYVCl-YmdZekSOpSwAjyU8BAL8mZoKhVSkOWXFIykrePnBhxe-Jhvp0hZhi7QigQpPqxKVCoMufIy4ID8GIEzEUOqExVPH9iyw_5M1uCAJWXvMQFO09pA4ACVfmFLZDLiitUS3a3avYUE2VNnJ6ySM6PYehT5vomG9o271xN3bs4zVTos52jJrgxBp8N07hzY6B-TJfsrHVdoq_H94I93t48XN_n6993v65X69xLJcdcVsCRlGpMXRlNjSlNS6RVXXLVtB45AggvgDi2WqHQtTe1rA1XGpVwQlywn---u6neUuPn7Og6u4th6-KLHVyw_yt9-GOfhr1Fo6Ws9GxwdTSIw9-J0mi3IXnqOtfTMCWruTYcBD8l-TikFKn9CEGwhy3sxh7Ktoey7WELO29hhX3bwj7PBt_-_erp_Fj-DHw_Ai5517XR9T6kEyclmMpU4hU1o5SK</recordid><startdate>20021201</startdate><enddate>20021201</enddate><creator>HOREN, Benjamin</creator><creator>MONTASTRUC, Jean-Louis</creator><creator>LAPEYRE-MESTRE, Maryse</creator><general>Blackwell Science</general><general>Blackwell Science Inc</general><scope>IQODW</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>7X8</scope><scope>5PM</scope></search><sort><creationdate>20021201</creationdate><title>Adverse drug reactions and off-label drug use in paediatric outpatients</title><author>HOREN, Benjamin ; MONTASTRUC, Jean-Louis ; LAPEYRE-MESTRE, Maryse</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c464t-49021e66d8b987ed858fee76b526dfc121003c30e21f76137bc8b4b8267163a33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Adolescent</topic><topic>Biological and medical sciences</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Drug Labeling</topic><topic>Drug Prescriptions</topic><topic>Drug toxicity and drugs side effects treatment</topic><topic>Drug-Related Side Effects and Adverse Reactions</topic><topic>Female</topic><topic>France</topic><topic>Humans</topic><topic>Infant</topic><topic>Infant, Newborn</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Miscellaneous (drug allergy, mutagens, teratogens...)</topic><topic>Outpatients</topic><topic>Pediatrics - methods</topic><topic>Pharmacology. Drug treatments</topic><topic>Prospective Studies</topic><topic>Short Reports</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>HOREN, Benjamin</creatorcontrib><creatorcontrib>MONTASTRUC, Jean-Louis</creatorcontrib><creatorcontrib>LAPEYRE-MESTRE, Maryse</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>British journal of clinical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>HOREN, Benjamin</au><au>MONTASTRUC, Jean-Louis</au><au>LAPEYRE-MESTRE, Maryse</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Adverse drug reactions and off-label drug use in paediatric outpatients</atitle><jtitle>British journal of clinical pharmacology</jtitle><addtitle>Br J Clin Pharmacol</addtitle><date>2002-12-01</date><risdate>2002</risdate><volume>54</volume><issue>6</issue><spage>665</spage><epage>670</epage><pages>665-670</pages><issn>0306-5251</issn><eissn>1365-2125</eissn><coden>BCPHBM</coden><abstract>To investigate the potential relationship between off-label drug use and increased risk of adverse drug reactions in paediatric outpatients. A prospective pharmacovigilance survey of drug prescribing in office based paediatricians was carried out in Haute-Garonne County (south west of France). The study involved a sample of 1419 children under 16 years old. Forty-two percent of patients were exposed to at least one off-label prescription. The incidence of adverse drug reactions was 1.41% (95% CI 0.79, 2.11). Off-label drug use was significantly associated with adverse drug reactions (relative risk 3.44; 95% CI 1.26, 9.38), particularly when it was due to an indication different than that defined in the Summary Product Characteristics (relative risk 4.42; 95% CI 1.60, 12.25). Our data suggest an increasing risk of adverse drug reactions related to off-label drug use. This risk would be acceptable if further studies prove the potential benefit of such a drug use.</abstract><cop>London</cop><pub>Blackwell Science</pub><pmid>12492616</pmid><doi>10.1046/j.1365-2125.2002.t01-3-01689.x</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record>
fulltext	fulltext
identifier	ISSN: 0306-5251
ispartof	British journal of clinical pharmacology, 2002-12, Vol.54 (6), p.665-670
issn	0306-5251 1365-2125
language	eng
recordid	cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_1874497
source	Wiley-Blackwell Read & Publish Collection
subjects	Adolescent Biological and medical sciences Child Child, Preschool Drug Labeling Drug Prescriptions Drug toxicity and drugs side effects treatment Drug-Related Side Effects and Adverse Reactions Female France Humans Infant Infant, Newborn Male Medical sciences Miscellaneous (drug allergy, mutagens, teratogens...) Outpatients Pediatrics - methods Pharmacology. Drug treatments Prospective Studies Short Reports
title	Adverse drug reactions and off-label drug use in paediatric outpatients
url	http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-17T17%3A12%3A00IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Adverse%20drug%20reactions%20and%20off-label%20drug%20use%20in%20paediatric%20outpatients&rft.jtitle=British%20journal%20of%20clinical%20pharmacology&rft.au=HOREN,%20Benjamin&rft.date=2002-12-01&rft.volume=54&rft.issue=6&rft.spage=665&rft.epage=670&rft.pages=665-670&rft.issn=0306-5251&rft.eissn=1365-2125&rft.coden=BCPHBM&rft_id=info:doi/10.1046/j.1365-2125.2002.t01-3-01689.x&rft_dat=%3Cproquest_pubme%3E72782032%3C/proquest_pubme%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c464t-49021e66d8b987ed858fee76b526dfc121003c30e21f76137bc8b4b8267163a33%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=72782032&rft_id=info:pmid/12492616&rfr_iscdi=true