{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,28]],"date-time":"2026-03-28T12:44:06Z","timestamp":1774701846015,"version":"3.50.1"},"reference-count":25,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2024,4,29]],"date-time":"2024-04-29T00:00:00Z","timestamp":1714348800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Stevens\u2013Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare life\u2010threatening mucocutaneous reactions most often induced by drugs. To date, no large pharmacovigilance study has been conducted in the paediatric population.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To describe the spectrum of drugs associated with SJS\u2010TEN in children through the analysis of cases reported in the WHO pharmacovigilance database (VigiBase).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Disproportionality study using data from VigiBase. All paediatric (age under 18\u2009years) cases reported between January 1, 1967, and July 6, 2022, were included. For each molecule, a case\u2013non\u2010case study was performed to assess a potential pharmacovigilance signal by computing the lower end of the 95% credibility interval for the information component (IC<jats:sub>025<\/jats:sub>). We performed sensitivity analyses, (i) taking into account only cases reported by physicians and (ii) taking into account only cases reported in the last 10\u2009years.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among 31,376,783 adverse drug reactions reported in VigiBase, 2,248,727 were paediatric cases and 7342 were encoded as paediatric SJS\u2010TEN. Significant statistical pharmacovigilance signals were observed for 165 drugs. The two most represented drug classes were antiepileptics and anti\u2010infectious drugs. The five drugs with the highest IC<jats:sub>025<\/jats:sub> were lamotrigine (IC<jats:sub>025<\/jats:sub> 4.99), carbamazepine (IC<jats:sub>025<\/jats:sub> 4.88), phenobarbital (IC<jats:sub>025<\/jats:sub> 4.67), phenytoin (IC<jats:sub>025<\/jats:sub> 4.52) and nimesulide (IC<jats:sub>025<\/jats:sub> 4.23). Acetaminophen was significantly associated with paediatric SJS\u2010TEN (IC<jats:sub>025<\/jats:sub> 2.85) and we also described various new suspected drugs. Vaccines had no significant pharmacovigilance signal. These results were confirmed with the sensitivity analyses.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This study updates the spectrum of drugs potentially associated with paediatric SJS\u2010TEN.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdv.20054","type":"journal-article","created":{"date-parts":[[2024,4,29]],"date-time":"2024-04-29T10:49:03Z","timestamp":1714387743000},"page":"1791-1798","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Drugs associated with epidermal necrolysis in children: A World Health Organization pharmacovigilance database analysis"],"prefix":"10.1111","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6975-5941","authenticated-orcid":false,"given":"Pauline","family":"Bataille","sequence":"first","affiliation":[{"name":"Department of Pediatric Dermatology, H\u00f4pital Necker\u2010Enfants Malades Hospital APHP, Paris City University  Paris France"},{"name":"Reference Center of Toxic Bullous Diseases and Severe Drug Reactions TOXIBUL  Cr\u00e9teil France"},{"name":"General Paediatrics, Department of Infectious Disease and Internal Medicine Robert Debr\u00e9 Mother\u2010Child University Hospital, AP\u2010HP  Paris France"},{"name":"Paris City University, Imagine Institute, Data Science Platform, INSERM UMR 1163  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benedicte","family":"Lebrun\u2010Vignes","sequence":"additional","affiliation":[{"name":"Reference Center of Toxic Bullous Diseases and Severe Drug Reactions TOXIBUL  Cr\u00e9teil France"},{"name":"Regional Pharmacovigilance Center, Department of Pharmacology AP\u2010HP, Sorbonne Universit\u00e9, Piti\u00e9\u2010Salp\u00eatri\u00e8re Hospital  Paris France"},{"name":"Universit\u00e9 Paris Est Cr\u00e9teil EpidermE, UPEC  Cr\u00e9teil France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Bettuzzi","sequence":"additional","affiliation":[{"name":"Reference Center of Toxic Bullous Diseases and Severe Drug Reactions TOXIBUL  Cr\u00e9teil France"},{"name":"Regional Pharmacovigilance Center, Department of Pharmacology AP\u2010HP, Sorbonne Universit\u00e9, Piti\u00e9\u2010Salp\u00eatri\u00e8re Hospital  Paris France"},{"name":"Universit\u00e9 Paris Est Cr\u00e9teil EpidermE, UPEC  Cr\u00e9teil France"},{"name":"Dermatology Department AP\u2010HP, Henri Mondor Hospital  Cr\u00e9teil France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5383-7096","authenticated-orcid":false,"given":"Saskia","family":"Ingen\u2010Housz\u2010Oro","sequence":"additional","affiliation":[{"name":"Reference Center of Toxic Bullous Diseases and Severe Drug Reactions TOXIBUL  Cr\u00e9teil France"},{"name":"Universit\u00e9 Paris Est Cr\u00e9teil EpidermE, UPEC  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