{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,29]],"date-time":"2025-09-29T20:36:39Z","timestamp":1759178199662,"version":"3.41.2"},"reference-count":15,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2024,6,5]],"date-time":"2024-06-05T00:00:00Z","timestamp":1717545600000},"content-version":"vor","delay-in-days":4,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2024,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Methylphenidate (MPH) is a common treatment of attention\u2010deficit\/hyperactivity disorder (ADHD). Concern has been raised regarding its cardiovascular safety, partly in relation with its micromolar affinity for the 5\u2010HT<jats:sub>2B<\/jats:sub> receptor, whose activation may result in valvular heart disease (VHD).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>To explore the association between the use of MPH and VHD reporting, we performed a disproportionality analysis within the WHO global safety database (VigiBase) using data, since inception until March 6th 2024, from: (i) the full database and (ii) different age groups (children\/adolescents 6\u201317\u2009years; adults 18\u201364\u2009years). To avoid competition bias, safety reports with amphetamine\u2010like appetite suppressants were excluded. Disproportionality was expressed using reporting odds\u2010ratio (ROR) and its 95% confidence interval (CI).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 29\u2009129 spontaneous reports with MPH, 23 VHD cases (7.9 per 10\u2009000 reports) were identified, including 13 adults and 10 children. Most cases concerned injury on the mitral valve. A disproportionate reporting was observed overall (ROR 1.6, 95% CI 1.1\u20132.4). Analysis according to age group found that disproportionality in VHD reporting was found in adults only (ROR 2.7, 95% CI 1.6\u20134.7) but not in children\/adolescents (ROR 1.7, 95% CI 0.9\u20133.2). Furthermore, amongst MPH users only, VHD reporting was higher in adults compared to children (ROR 2.7, 95% CI 1.2\u20136.3).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>VHD reporting appears rare with MPH compared to other adverse events and is increased in adults only. Our findings support a potential safety signal of VHD in adults exposed to MPH. A risk in that population cannot be excluded and requires further assessment.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.5814","type":"journal-article","created":{"date-parts":[[2024,6,5]],"date-time":"2024-06-05T07:30:02Z","timestamp":1717572602000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Use of methylphenidate and reporting of valvular heart disease: Global pharmacovigilance analysis in children and adults"],"prefix":"10.1002","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0613-3803","authenticated-orcid":false,"given":"Estelle","family":"Ayme\u2010Dietrich","sequence":"first","affiliation":[{"name":"Laboratoire de Pharmacologie et Toxicologie NeuroCardiovasculaire UR7296, H\u00f4pitaux Universitaires de Strasbourg, Universit\u00e9 de Strasbourg  Strasbourg France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7842-5602","authenticated-orcid":false,"given":"Florentia","family":"Kaguelidou","sequence":"additional","affiliation":[{"name":"Centre d'Investigations Clinique INSERM CIC1426, H\u00f4pital Robert Debr\u00e9, APHP Nord  Paris France"},{"name":"URP7323 \u00ab Pharmacologie et \u00e9valuation des th\u00e9rapeutiques chez l'enfant et la femme enceinte \u00bb Universit\u00e9 Paris Cit\u00e9  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0827-7659","authenticated-orcid":false,"given":"Gilles","family":"Bertschy","sequence":"additional","affiliation":[{"name":"Service de Psychiatrie 2 Unit\u00e9 INSERM 1329, H\u00f4pitaux Universitaires de Strasbourg, Universit\u00e9 de Strasbourg  Strasbourg France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9626-3571","authenticated-orcid":false,"given":"Laurent","family":"Chouchana","sequence":"additional","affiliation":[{"name":"URP7323 \u00ab Pharmacologie et \u00e9valuation des th\u00e9rapeutiques chez l'enfant et la femme enceinte \u00bb Universit\u00e9 Paris Cit\u00e9  Paris France"},{"name":"Centre R\u00e9gional de Pharmacovigilance, Service de Pharmacologie P\u00e9rinatale P\u00e9diatrique et Adulte H\u00f4pital Cochin, APHP. Centre \u2013 Universit\u00e9 Paris Cit\u00e9  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,6,5]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijerph15081789"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2215\u20100366(23)00042\u20101"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2022.43597"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1089\/cap.2006.16.687"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.283.13.1703"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.2165\/11539410-000000000-00000"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2011.04037.x"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41390-018-0256-9"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4954"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.2044"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/bph.13981"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcpt.13707"},{"key":"e_1_2_12_14_1","first-page":"185","article-title":"Risk prediction model for cardiovascular diseases in adults initiating pharmacological treatment for attention\u2010deficit\/hyperactivity disorder","volume":"25","author":"Dobrosavljevic M","year":"2022","journal-title":"BMJ Ment Health"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.neubiorev.2023.105209"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cpr.2021.102039"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.5814","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,7,26]],"date-time":"2024-07-26T02:41:45Z","timestamp":1721961705000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.5814"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,6]]},"references-count":15,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2024,6]]}},"alternative-id":["10.1002\/pds.5814"],"URL":"https:\/\/doi.org\/10.1002\/pds.5814","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"type":"print","value":"1053-8569"},{"type":"electronic","value":"1099-1557"}],"subject":[],"published":{"date-parts":[[2024,6]]},"assertion":[{"value":"2023-10-11","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-04-26","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-06-05","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e5814"}}