{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,26]],"date-time":"2026-04-26T04:44:12Z","timestamp":1777178652830,"version":"3.51.4"},"reference-count":36,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2023,7,3]],"date-time":"2023-07-03T00:00:00Z","timestamp":1688342400000},"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":[[2023,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>To describe the symptoms, patient demographics, and trends over time of adverse drug reactions (ADRs) related to weak opioid analgesics reported to the French vigilance networks.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Retrospective study of data from French Poison Control Centers and Pharmacovigilance Centers databases of weak opioid analgesics\u2010related ADRs cases, with high causality score, in adults, in therapeutic analgesic use, without co\u2010exposure, between 2011 and 2020.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The number of cases was 388 in the Poisonings database and 155 in the Pharmacovigilance database; ratio of the number of these cases to all reported cases during the study period was 0.02% and 0.03%, respectively. Tramadol was most often involved (74% and 56.1%, respectively), followed by codeine (26% and 38.7%, respectively). There was no significant variation in the number of cases reported. Cases most often involved young adults (median age: 40\u2009years) and mostly women (76%). Gastrointestinal symptoms were mostly reported (80% and 65%, respectively) as described in the Summary of Products Characteristics. Patterns of ADRs were comparable in both databases, except for codeine\u2010associated acute pancreatitis and anaphylaxis that were reported in the Pharmacovigilance database. No fatality was observed. Severity was more often observed in the Pharmacovigilance database (30%) than in the Poisonings database (moderate toxicity: 7%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>ADRs mostly occurred among young women using tramadol, without significant variation in the number of reported cases over time. Serious ADRs were more frequently reported to the Pharmacovigilance database, particularly for codeine. Women seemed to be at greater risk of ADRs.<\/jats:p><\/jats:sec>","DOI":"10.1111\/fcp.12929","type":"journal-article","created":{"date-parts":[[2023,7,4]],"date-time":"2023-07-04T01:23:31Z","timestamp":1688433811000},"page":"1205-1217","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Trends in adverse drug reactions related to oral weak opioid analgesics in therapeutic use in adults: A 10\u2010year French vigilances retrospective study"],"prefix":"10.1111","volume":"37","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4559-8670","authenticated-orcid":false,"given":"Weniko","family":"Car\u00e9","sequence":"first","affiliation":[{"name":"Paris Poison Control Center Toxicology Federation (FeTox), H\u00f4pital Fernand Widal, AP\u2010HP  Paris France"},{"name":"Internal Medicine Department B\u00e9gin Military Teaching Hospital  Saint\u2010Mand\u00e9 France"},{"name":"Optimisation Th\u00e9rapeutique en Neuropsychopharmacologie Universit\u00e9 Paris Cit\u00e9, Inserm  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sylvine","family":"Pinel","sequence":"additional","affiliation":[{"name":"Regional Pharmacovigilance Center H\u00f4pital Fernand Widal, AP\u2010HP  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laur\u00e8ne","family":"Dufayet","sequence":"additional","affiliation":[{"name":"Paris Poison Control Center Toxicology Federation (FeTox), H\u00f4pital Fernand Widal, AP\u2010HP  Paris France"},{"name":"Optimisation Th\u00e9rapeutique en Neuropsychopharmacologie Universit\u00e9 Paris Cit\u00e9, Inserm  Paris France"},{"name":"Forensic Department H\u00f4pital H\u00f4tel Dieu, AP\u2010HP  Paris France"},{"name":"UFR de m\u00e9decine Universit\u00e9 de Paris  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J\u00e9r\u00f4me","family":"Langrand","sequence":"additional","affiliation":[{"name":"Paris Poison Control Center Toxicology Federation (FeTox), H\u00f4pital Fernand Widal, AP\u2010HP  Paris France"},{"name":"Optimisation Th\u00e9rapeutique en Neuropsychopharmacologie Universit\u00e9 Paris Cit\u00e9, Inserm  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7172-7835","authenticated-orcid":false,"given":"Jo\u00eblle","family":"Micallef","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Department, Regional Pharmacovigilance Center Assistance publique\u2014H\u00f4pitaux de Marseille  Marseille France"},{"name":"INSERM, UMR 1106  Marseille France"},{"name":"Universit\u00e9 d'Aix\u2010Marseille  Marseille France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dominique","family":"Vodovar","sequence":"additional","affiliation":[{"name":"Paris Poison Control Center Toxicology Federation (FeTox), H\u00f4pital Fernand Widal, AP\u2010HP  Paris France"},{"name":"Optimisation Th\u00e9rapeutique en Neuropsychopharmacologie Universit\u00e9 Paris Cit\u00e9, Inserm  Paris France"},{"name":"UFR de m\u00e9decine Universit\u00e9 de Paris  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,7,3]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13564"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(16)00161\u20106"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/ejp.1291"},{"key":"e_1_2_12_5_1","volume-title":"Use and Abuse of Opioid Analgesics \u2010 Situation Report","author":"National Agency for the Safety of Medicines and Health Products (ANSM)","year":"2019"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.14415"},{"key":"e_1_2_12_7_1","volume-title":"R\u00e9pertoire des sp\u00e9cialit\u00e9s pharmaceutiques","author":"National Agency for the Safety of Medicines and Health Products (ANSM)","year":"2021"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.2515\/therapie\/2013021"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1472\u20108206.2008.00661.x"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.2515\/therapie\/2011037"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.therap.2017.03.004"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365\u20102125.2009.03472.x"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpain.2016.08.010"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4056"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/fcp.12534"},{"key":"e_1_2_12_16_1","unstructured":"Comit\u00e9 de Coordination de la Toxicovigilance\u2014Groupe de travail Qualit\u00e9 et M\u00e9thodes.M\u00e9thode d'imputabilit\u00e9 en toxicovigilance.2015. 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