{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T16:17:24Z","timestamp":1790439444003,"version":"4.1.0"},"reference-count":40,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2020,6,17]],"date-time":"2020-06-17T00:00:00Z","timestamp":1592352000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2020,11]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>Amoxicillin (AMX)\u2010induced crystal nephropathy (AICN) is a rarely reported adverse drug reaction (ADR) but its increase has been recently reported in the Paris area. Our aim was to investigate the incidence, characteristics and outcome of AICN in France.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Retrospective analysis of all AICN cases reported to the French National Pharmacovigilance Database and the Marketing Authorization Holders Pharmacovigilance Database. AICN notification rate was compared to intravenous AMX and AMX\u2013clavulanate sales.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In total, 101 AICN cases were included. Intravenous AMX\/AMX\u2013clavulanate was prescribed as surgical prophylaxis (32 surgical patients) or to treat infection (69 medical patients). AKI KDIGO stage 3 was observed in 70 patients and 24\/70 patients required renal replacement therapy and\/or intensive care unit admission. The annual notification rate of AICN was increased by a factor of 13 since 2010 (6 [0;7] and 77 [24;111] cases per 100 000 patient\u2010years of exposure, before and after 2010 respectively; <jats:italic>P<\/jats:italic> &lt; .001). In surgical patients, the increase in AICN has been reported since 2010 and was mainly related to inadequate AMX administration. In medical patients, the increase in AICN was observed since 2014. After 2014, medical patients were older (67 [42;77] <jats:italic>vs<\/jats:italic> 74 years [64;84] respectively; <jats:italic>P<\/jats:italic> &lt; .05) and were treated more frequently for endocarditis (0\/20 <jats:italic>vs<\/jats:italic> 15\/49 respectively; <jats:italic>P<\/jats:italic> &lt; .01). A contributing factor was observed or suspected in 62 patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>AICN is a severe ADR that dramatically increased in France since 2010. Assessment of AICN contributing factors and AMX drug monitoring in patients receiving high dose of AMX could reduce the risk of AICN.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.14328","type":"journal-article","created":{"date-parts":[[2020,4,30]],"date-time":"2020-04-30T19:41:31Z","timestamp":1588275691000},"page":"2256-2265","source":"Crossref","is-referenced-by-count":18,"title":["Amoxicillin\u2010induced crystal nephropathy: A nationwide French pharmacovigilance databases study"],"prefix":"10.1111","volume":"86","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4777-5690","authenticated-orcid":false,"given":"Laure","family":"Thomas","sequence":"first","affiliation":[{"name":"Centre R\u00e9gional de Pharmacovigilance, Assistance Publique\u2010H\u00f4pitaux de Paris (AH\u2010HP), H\u00f4pitaux Universitaires Henri Mondor  Cr\u00e9teil France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Le Beller","sequence":"additional","affiliation":[{"name":"Centre R\u00e9gional de Pharmacovigilance, Assistance Publique\u2010H\u00f4pitaux de Paris (AH\u2010HP), H\u00f4pital Europ\u00e9en Georges Pompidou, F\u201075014  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5645-8366","authenticated-orcid":false,"given":"Thierry","family":"Trenque","sequence":"additional","affiliation":[{"name":"Centre R\u00e9gional de Pharmacovigilance et de Pharmaco\u00e9pid\u00e9miologie, Centre Hospitalier Universitaire  Reims France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jo\u00eblle","family":"Michot","sequence":"additional","affiliation":[{"name":"Centre R\u00e9gional de Pharmacovigilance, Assistance Publique\u2010H\u00f4pitaux de Paris (AH\u2010HP), Centre Hospitalier Universitaire Saint\u2010Antoine  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie","family":"Zenut","sequence":"additional","affiliation":[{"name":"Centre R\u00e9gional de Pharmacovigilance, Centre Hospitalier Universitaire  Clermont\u2010Ferrand France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuel","family":"Letavernier","sequence":"additional","affiliation":[{"name":"Institut National de la Sant\u00e9 et de la Recherche M\u00e9dicale, Unit\u00e9 Mixte de Recherche_S1155, Rare and Common Kidney Diseases, Matrix Remodeling and Tissue Repair  Paris France"},{"name":"Sorbonne Universit\u00e9s Universit\u00e9 Pierre et Marie Curie, Universit\u00e9 Paris 6  Paris France"},{"name":"Explorations fonctionnelles multidisciplinaires, H\u00f4pital Tenon, Assistance Publique \u2010 H\u00f4pitaux de Paris (AH\u2010HP)  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Mongardon","sequence":"additional","affiliation":[{"name":"Service d'anesth\u00e9sie\u2010r\u00e9animation chirurgicale, DMU CARE, Assistance Publique\u2010H\u00f4pitaux de Paris (AP\u2010HP), H\u00f4pitaux Universitaires Henri Mondor  Cr\u00e9teil France"},{"name":"Universit\u00e9 Paris Est Cr\u00e9teil, Facult\u00e9 de Sant\u00e9  Cr\u00e9teil France"},{"name":"U955\u2010IMRB, Equipe 03 \"Strat\u00e9gies pharmacologiques et th\u00e9rapeutiques exp\u00e9rimentales des insuffisances cardiaques et coronaires\", Inserm, UPEC, Ecole Nationale V\u00e9t\u00e9rinaire d'Alfort  Maisons\u2010Alfort France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8196-5511","authenticated-orcid":false,"given":"Dominique","family":"Vodovar","sequence":"additional","affiliation":[{"name":"Centre Anti\u2010Poison et de Toxicovigilance de Paris \u2010 F\u00e9d\u00e9ration de toxicologie, Assistance Publique des H\u00f4pitaux de Paris, H\u00f4pital Fernand\u2010Widal  Paris France"},{"name":"UFR de m\u00e9decine, Universit\u00e9 Paris\u2010Diderot  Paris France"},{"name":"UMRS 1144, Inserm, Facult\u00e9 de Pharmacie  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,6,17]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"World Health Organization.WHO report on surveillance of antibiotic consumption: 2016\u20132018 early implementation.https:\/\/www.who.int\/medicines\/areas\/rational_use\/who-amr-amc-report-20181109.pdf. 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