{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T09:22:08Z","timestamp":1787563328339,"version":"build-2736575974"},"reference-count":36,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2020,12,29]],"date-time":"2020-12-29T00:00:00Z","timestamp":1609200000000},"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":[[2021,7]]},"abstract":"<jats:p>We describe the safety profiles of all drug classes used for the treatment of advanced melanoma from the US Food and Drug Administration Adverse Event Reporting System over 2008\u20132018. Adverse reactions reported in 25\u2009900 pharmacovigilance cases are described for chemotherapies, immunomodulators, targeted therapies and immunotherapies. There was a sharp increase in the number of cases over time, with peaks associated with the launch of new treatments. The adverse reactions diversified over time; notably, skin (alopecias, dermatitis) and retinal disorders were frequently associated with targeted therapies and endocrine disorders (hypothalamus, thyroid and adrenal dysfunctions) with immunotherapies. Less well\u2010known reactions were also detected, such as neuropsychiatric disorders with targeted therapies and gastrointestinal ulcers, pneumothorax and pleural effusions with immunotherapies. The findings highlight the need for various health professionals (including medical specialists or trained nurses) to enhance management of complications.<\/jats:p>","DOI":"10.1111\/bcp.14693","type":"journal-article","created":{"date-parts":[[2020,12,10]],"date-time":"2020-12-10T00:54:36Z","timestamp":1607561676000},"page":"2988-2995","source":"Crossref","is-referenced-by-count":2,"title":["Safety profile of drugs for advanced melanoma: A report based on 2008\u20132018 US Food and Drug Administration Data"],"prefix":"10.1111","volume":"87","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1891-417X","authenticated-orcid":false,"given":"Emilie","family":"Casarotto","sequence":"first","affiliation":[{"name":"Inserm, Bordeaux Population Health Research Center, Team Pharmacoepidemiology, UMR 1219 Univ. Bordeaux  Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pernelle","family":"Noize","sequence":"additional","affiliation":[{"name":"Inserm, Bordeaux Population Health Research Center, Team Pharmacoepidemiology, UMR 1219 Univ. Bordeaux  Bordeaux France"},{"name":"Department of Pharmacology Bordeaux University Hospital  Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louis","family":"L\u00e9tinier","sequence":"additional","affiliation":[{"name":"Inserm, Bordeaux Population Health Research Center, Team Pharmacoepidemiology, UMR 1219 Univ. Bordeaux  Bordeaux France"},{"name":"Department of Pharmacology Bordeaux University Hospital  Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3210-7171","authenticated-orcid":false,"given":"Francesco","family":"Salvo","sequence":"additional","affiliation":[{"name":"Inserm, Bordeaux Population Health Research Center, Team Pharmacoepidemiology, UMR 1219 Univ. Bordeaux  Bordeaux France"},{"name":"Department of Pharmacology Bordeaux University Hospital  Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Pham\u2010Ledard","sequence":"additional","affiliation":[{"name":"Inserm, Bordeaux Population Health Research Center, Team Pharmacoepidemiology, UMR 1219 Univ. Bordeaux  Bordeaux France"},{"name":"Department of Dermatology Bordeaux University Hospital and Univ. Bordeaux  Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mathieu","family":"Molimard","sequence":"additional","affiliation":[{"name":"Inserm, Bordeaux Population Health Research Center, Team Pharmacoepidemiology, UMR 1219 Univ. Bordeaux  Bordeaux France"},{"name":"Department of Pharmacology Bordeaux University Hospital  Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,12,29]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.15586\/codon.cutaneousmelanoma.2017.ch1"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.3322\/canjclin.50.4.215"},{"issue":"21","key":"e_1_2_10_4_1","first-page":"591","article-title":"Vital Signs: Melanoma Incidence and Mortality Trends and Projections \u2014 United States, 1982\u20132030","volume":"64","author":"Guy GP","year":"2015","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"e_1_2_10_5_1","unstructured":"American institute for Cancer Research.Worldwide cancer data. Published August 6 2018. Accessed July 2 2019.https:\/\/www.wcrf.org\/dietandcancer\/cancer\u2010trends\/worldwide\u2010cancer\u2010data"},{"key":"e_1_2_10_6_1","unstructured":"Globocan.Melanoma of skin. Accessed July 2 2019.http:\/\/gco.iarc.fr\/today\/data\/factsheets\/cancers\/16\u2010Melanoma\u2010of\u2010skin\u2010fact\u2010sheet.pdf"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/archsurg.139.9.961"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.coph.2019.05.010"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clim.2016.07.006"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1177\/1758834012466280"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.4103\/apjon.apjon_79_17"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.21037\/atm.2016.04.01"},{"key":"e_1_2_10_13_1","volume-title":"Current Trends in Cancer Management","author":"Karachi A"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.12164"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.det.2019.05.001"},{"key":"e_1_2_10_16_1","first-page":"1827","article-title":"Treating the Treatment: Toxicity of Cancer Chemotherapy","volume":"36","author":"Plenderleith IH","year":"1990","journal-title":"Can Fam Physician"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13054-017-1678-1"},{"key":"e_1_2_10_18_1","unstructured":"Canadian Cancer Society.Side effects of chemotherapy.www.cancer.ca. Accessed September 11 2019.https:\/\/www.cancer.ca:443\/en\/cancer-information\/diagnosis-and\u2010treatment\/chemotherapy\u2010and\u2010other\u2010drug\u2010therapies\/chemotherapy\/side\u2010effects\u2010of\u2010chemotherapy\/?region=on"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.14159"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40425-019-0617-x"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.joco.2019.05.002"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(18)30608-9"},{"key":"e_1_2_10_23_1","unstructured":"FAERS Quarterly Data Extract Files. Accessed June 10 2020.https:\/\/fis.fda.gov\/extensions\/FPD\u2010QDE\u2010FAERS\/FPD\u2010QDE\u2010FAERS.html"},{"key":"e_1_2_10_24_1","doi-asserted-by":"crossref","unstructured":"FDA.Questions and Answers on FDA's Adverse Event Reporting System (FAERS). Published May 22 2019. Accessed February 14 2020.http:\/\/www.fda.gov\/drugs\/surveillance\/questions\u2010and\u2010answers\u2010fdas\u2010adverse\u2010event\u2010reporting\u2010system\u2010faers","DOI":"10.5582\/bst.2020.03082"},{"key":"e_1_2_10_25_1","unstructured":"GieseP.HO04 \u2010 MedDRA\u2010 Beyond that basic AE report. How SMQs and MedDRA structure can enhance reporting. :10."},{"key":"e_1_2_10_26_1","unstructured":"National Cancer Institute.Drugs Approved for Melanoma. Published May 16 2011. Accessed July 2 2019.https:\/\/www.cancer.gov\/about\u2010cancer\/treatment\/drugs\/melanoma"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11096-018-0706-9"},{"issue":"1","key":"e_1_2_10_28_1","first-page":"39","article-title":"Concurrent phase I trials of intravenous interleukin 6 in solid tumor patients: reversible dose\u2010limiting neurological toxicity","volume":"3","author":"Sosman JA","year":"1997","journal-title":"Clin Cancer Res"},{"issue":"1","key":"e_1_2_10_29_1","first-page":"48","article-title":"Cutaneous Toxicities of Molecular Targeted Therapies","volume":"12","author":"Stanculeanu DL","year":"2017","journal-title":"M\u00e6dica"},{"key":"e_1_2_10_30_1","doi-asserted-by":"crossref","unstructured":"SharmaD.Ophthalmic complications of targeted therapies: a review. Accessed March 3 2020.http:\/\/www.djo.eg.net\/article.asp?issn=1110\u20109173;year=2017;volume=18;issue=3;spage=117;epage=122;aulast=Sharma","DOI":"10.4103\/DJO.DJO_23_17"},{"key":"e_1_2_10_31_1","doi-asserted-by":"publisher","DOI":"10.1530\/ERC-17-0358"},{"key":"e_1_2_10_32_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2020.00830"},{"key":"e_1_2_10_33_1","doi-asserted-by":"publisher","DOI":"10.1177\/1078155218790331"},{"key":"e_1_2_10_34_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12890-018-0775-5"},{"key":"e_1_2_10_35_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40425-016-0185-2"},{"key":"e_1_2_10_36_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2125.1997.05417.x"},{"key":"e_1_2_10_37_1","doi-asserted-by":"publisher","DOI":"10.1007\/s002280050498"}],"container-title":["British Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bcp.14693","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/bcp.14693","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bcp.14693","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,29]],"date-time":"2023-08-29T06:14:52Z","timestamp":1693289692000},"score":1,"resource":{"primary":{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/10.1111\/bcp.14693"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,12,29]]},"references-count":36,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2021,7]]}},"alternative-id":["10.1111\/bcp.14693"],"URL":"https:\/\/doi.org\/10.1111\/bcp.14693","archive":["Portico"],"relation":{},"ISSN":["0306-5251","1365-2125"],"issn-type":[{"value":"0306-5251","type":"print"},{"value":"1365-2125","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,12,29]]}}}