{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,10]],"date-time":"2026-06-10T10:07:21Z","timestamp":1781086041841,"version":"3.54.1"},"reference-count":9,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2020,3,10]],"date-time":"2020-03-10T00:00:00Z","timestamp":1583798400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Fundamemntal Clinical Pharma"],"published-print":{"date-parts":[[2020,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>In adults, statins safety profile is well known. However, literature data on their adverse drug reactions (ADRs) remain scarce in children in real\u2010life setting. In order to better characterize ADRs related to \u2018real\u2010life\u2019 use of statins in children, we reviewed statin\u2010related ADRs recorded in the World Health Organization (WHO) global database of individual case safety reports (ICSRs), VigiBase. Methods. Individual case safety reports (ICSRs) in children (2\u201311\u00a0years) and adolescents (12\u201317\u00a0years) associated with statins from January 1, 1987, to July 18, 2017, were extracted from VigiBase. Characteristics of ICSRs, type of ADRs according to MedDRA classification (SOC and PT), and ICSR seriousness were described using SAS 9.4. A total of 311 ICSRs were identified for 8 statins with 712 ADRs. Musculoskeletal disorders (<jats:italic>n<\/jats:italic>\u00a0=\u00a085, 27.3%) were the first registered ADRs followed by general disorders (<jats:italic>n<\/jats:italic>\u00a0=\u00a067, 21.5%; mainly asthenia and pain). More than 1 out of 5 ADRs were \u2018injury, poisoning and procedural complications\u2019 (<jats:italic>n<\/jats:italic>\u00a0=\u00a067), mainly accidental or intentional exposures (<jats:italic>n<\/jats:italic>\u00a0=\u00a044, 14.1%), overdoses (<jats:italic>n<\/jats:italic>\u00a0=\u00a014, 4.5%), or off\u2010label use (<jats:italic>n<\/jats:italic>\u00a0=\u00a011, 3.5%). Overall, 133 (42.8%) reports were \u2018serious\u2019, including 11 deaths. Deaths mainly involved adolescents with intentional overdose and completed suicide with other associated drugs in 75% of reports. Our study identified rare but serious safety issues (rhabdomyolysis, myalgia, and hepatocellular injury). These ADRs can impact quality of life or lead to life\u2010threatening complications in children. Our results should be supplemented with other data sources. Spontaneous statin ADR reports in children to pharmacovigilance networks must be promoted.<\/jats:p>","DOI":"10.1111\/fcp.12542","type":"journal-article","created":{"date-parts":[[2020,2,5]],"date-time":"2020-02-05T12:22:04Z","timestamp":1580905324000},"page":"518-520","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Adverse drug reactions of statins in children and adolescents: a descriptive analysis from VigiBase, the WHO global database of individual case safety reports"],"prefix":"10.1111","volume":"34","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7787-5740","authenticated-orcid":false,"given":"C\u00e9cile","family":"Conte","sequence":"first","affiliation":[{"name":"Facult\u00e9 de M\u00e9decine Laboratoire de Pharmacologie M\u00e9dicale et Clinique F\u201031000 Toulouse France"},{"name":"Service de Pharmacologie M\u00e9dicale et Clinique Centre de Pharmacovigilance de Pharmaco\u00e9pid\u00e9miologie et d\u2019Informations sur le M\u00e9dicament, CHU F\u201031000 Toulouse France"},{"name":"UMR 1027 Inserm\u2010Universit\u00e9 de Toulouse 31000 Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vanessa","family":"Rousseau","sequence":"additional","affiliation":[{"name":"Service de Pharmacologie M\u00e9dicale et Clinique Centre de Pharmacovigilance de Pharmaco\u00e9pid\u00e9miologie et d\u2019Informations sur le M\u00e9dicament, CHU F\u201031000 Toulouse France"},{"name":"UMR 1027 Inserm\u2010Universit\u00e9 de Toulouse 31000 Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotte","family":"Vert","sequence":"additional","affiliation":[{"name":"Service de Pharmacologie M\u00e9dicale et Clinique Centre de Pharmacovigilance de Pharmaco\u00e9pid\u00e9miologie et d\u2019Informations sur le M\u00e9dicament, CHU F\u201031000 Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7056-8126","authenticated-orcid":false,"given":"Fran\u00e7ois","family":"Montastruc","sequence":"additional","affiliation":[{"name":"Facult\u00e9 de M\u00e9decine Laboratoire de Pharmacologie M\u00e9dicale et Clinique F\u201031000 Toulouse France"},{"name":"Service de Pharmacologie M\u00e9dicale et Clinique Centre de Pharmacovigilance de Pharmaco\u00e9pid\u00e9miologie et d\u2019Informations sur le M\u00e9dicament, CHU F\u201031000 Toulouse France"},{"name":"UMR 1027 Inserm\u2010Universit\u00e9 de Toulouse 31000 Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6341-6001","authenticated-orcid":false,"given":"Jean\u2010Louis","family":"Montastruc","sequence":"additional","affiliation":[{"name":"Facult\u00e9 de M\u00e9decine Laboratoire de Pharmacologie M\u00e9dicale et Clinique F\u201031000 Toulouse France"},{"name":"Service de Pharmacologie M\u00e9dicale et Clinique Centre de Pharmacovigilance de Pharmaco\u00e9pid\u00e9miologie et d\u2019Informations sur le M\u00e9dicament, CHU F\u201031000 Toulouse France"},{"name":"UMR 1027 Inserm\u2010Universit\u00e9 de Toulouse 31000 Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3717-2784","authenticated-orcid":false,"given":"Genevi\u00e8ve","family":"Durrieu","sequence":"additional","affiliation":[{"name":"Facult\u00e9 de M\u00e9decine Laboratoire de Pharmacologie M\u00e9dicale et Clinique F\u201031000 Toulouse France"},{"name":"Service de Pharmacologie M\u00e9dicale et Clinique Centre de Pharmacovigilance de Pharmaco\u00e9pid\u00e9miologie et d\u2019Informations sur le M\u00e9dicament, CHU F\u201031000 Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pascale","family":"Olivier","sequence":"additional","affiliation":[{"name":"Facult\u00e9 de M\u00e9decine Laboratoire de Pharmacologie M\u00e9dicale et Clinique F\u201031000 Toulouse France"},{"name":"Service de Pharmacologie M\u00e9dicale et Clinique Centre de Pharmacovigilance de Pharmaco\u00e9pid\u00e9miologie et d\u2019Informations sur le M\u00e9dicament, CHU F\u201031000 Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,3,10]]},"reference":[{"key":"e_1_2_3_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.therap.2019.01.004"},{"key":"e_1_2_3_3_1","first-page":"CD006401","article-title":"Statins for children with familial hypercholesterolemia","volume":"7","author":"Vuorio A.","year":"2017","journal-title":"Cochrane Database Syst. 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