{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T18:03:27Z","timestamp":1765735407033,"version":"3.48.0"},"reference-count":31,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2021,8,12]],"date-time":"2021-08-12T00:00:00Z","timestamp":1628726400000},"content-version":"unspecified","delay-in-days":11,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003725","name":"National Research Foundation of Korea","doi-asserted-by":"publisher","award":["NRF-2020R1C1C1003527"],"award-info":[{"award-number":["NRF-2020R1C1C1003527"]}],"id":[{"id":"10.13039\/501100003725","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Government-wide R&D Fund project for Infectious Disease Research (GFID) of South Korea","award":["grant no. HG18C0068"],"award-info":[{"award-number":["grant no. HG18C0068"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,7,27]]},"published-print":{"date-parts":[[2021,8]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To detect the signals for drospirenone-containing oral contraceptives (DCOCs) and describe the reporting pattern of adverse events (AEs) caused by DCOCs compared with levonorgestrel\/desogestrel\/gestodene-containing (second\/third generation) oral contraceptives.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>A descriptive analysis of claims data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>The Korea Institute of Drug Safety &amp; Risk Management-Korea Adverse Event Reporting System Database from 1 February 2008 to 31 December 2017.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Outcome measures<\/jats:title>\n                    <jats:p>Signals for DCOCs were identified using three data mining indices. The characteristics, death cases, and the annual pattern of AE reports were compared between DCOCs and second\/third generation oral contraceptives.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of the 242 DCOC-related AEs, 54 signals were detected and 10 were identified as new signals that were not included in Korea, US and UK label. The newly detected signals include deep vein thrombophlebitis and frequent urination. Serious AEs were more likely to be reported with DCOCs (7.85%) than with second\/third generation oral contraceptives (2.92%). Five deaths after use of DCOCs were reported with vascular AEs, such as pulmonary embolism and thrombosis, whereas one death after use of second\/third generation oral contraceptives was reported with the cardiac arrest.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>We identified 10 new signals related to DCOCs that were not included in the current label. Additionally, we found higher reports of the deaths and vascular AEs associated with DCOCs than with second\/third generation oral contraceptives, which warrants careful monitoring to ensure the safe use of DCOCs.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-045948","type":"journal-article","created":{"date-parts":[[2021,8,13]],"date-time":"2021-08-13T13:01:44Z","timestamp":1628859704000},"page":"e045948","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Signal detection of drospirenone-containing oral contraceptives: a disproportionality analysis using the Korea Adverse Event Reporting System Database, 2008\u20132017"],"prefix":"10.1136","volume":"11","author":[{"given":"Yeri","family":"Lee","sequence":"first","affiliation":[{"name":"School of Pharmacy, Sungkyunkwan University, Suwon, Korea (the Republic of)"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ahhyung","family":"Choi","sequence":"additional","affiliation":[{"name":"School of Pharmacy, Sungkyunkwan University, Suwon, Korea (the Republic of)"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yunha","family":"Noh","sequence":"additional","affiliation":[{"name":"School of Pharmacy, Sungkyunkwan University, Suwon, Korea (the Republic of)"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ha-Lim","family":"Jeon","sequence":"additional","affiliation":[{"name":"School of Pharmacy, Sungkyunkwan University, Suwon, Korea (the Republic of)"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6270-5020","authenticated-orcid":false,"given":"Seung-Ah","family":"Choe","sequence":"additional","affiliation":[{"name":"Department of Preventive Medicine, College of Medicine, Korea University, Seoul, Korea (the Republic of)"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1010-7525","authenticated-orcid":false,"given":"Ju-Young","family":"Shin","sequence":"additional","affiliation":[{"name":"School of Pharmacy, Sungkyunkwan University, Suwon, Korea (the Republic of)"},{"name":"Department of Clinical Research Design and Evaluation, Samsung Advanced Institute for Health Sciences and Technology, Seoul, Korea (the Republic of)"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2021,8,13]]},"reference":[{"key":"2025121410003418000_11.8.e045948.1","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1016\/j.beem.2012.11.004","article-title":"History of oral contraceptive drugs and their use worldwide","volume":"27","author":"Christin-Maitre","year":"2013","journal-title":"Best Pract Res Clin Endocrinol Metab"},{"unstructured":"Korea Ministry of Food and Drug Safety (MFDS) . Online pharmaceutical library contraceptive information. Available: http:\/\/drug.mfds.go.kr\/html\/index.jsp [Accessed 14 Jun 2019].","key":"2025121410003418000_11.8.e045948.2"},{"key":"2025121410003418000_11.8.e045948.3","first-page":"1","article-title":"A survey of oral contraceptive utilization patterns and adverse event in Korean women aged 20 to 49 years","volume":"41","author":"Um","year":"2015","journal-title":"Korean Public Health Res"},{"unstructured":"The Food and Drug Administration (FDA) . Drug safety communication: updated information about the risk of blood clots in women taking birth control pills containing drospirenone, 2012. Available: https:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm299305.htm [Accessed 14 Jun 2019].","key":"2025121410003418000_11.8.e045948.4"},{"unstructured":"Korea Ministry of Food and Drug Safety (MFDS) . Drug safety information 2014:94\u2013100.","key":"2025121410003418000_11.8.e045948.5"},{"doi-asserted-by":"publisher","key":"2025121410003418000_11.8.e045948.6","DOI":"10.1002\/ijgo.12455"},{"key":"2025121410003418000_11.8.e045948.7","doi-asserted-by":"crossref","first-page":"29","DOI":"10.2147\/OAJC.S161737","article-title":"Drospirenone-containing oral contraceptives and venous thromboembolism: an analysis of the FAERS database","volume":"9","author":"Madigan","year":"2018","journal-title":"Open Access J Contracept"},{"doi-asserted-by":"publisher","key":"2025121410003418000_11.8.e045948.8","DOI":"10.1038\/clpt.2013.24"},{"unstructured":"Korea Institute of Drug Safety & Risk Management . Manual for using Korea institute of drug safety & risk management Korea adverse event reporting system database, 2018. Available: https:\/\/open.drugsafe.or.kr\/original\/guidelines\/List.jsp [Accessed 14 Jun 2019].","key":"2025121410003418000_11.8.e045948.9"},{"doi-asserted-by":"publisher","key":"2025121410003418000_11.8.e045948.10","DOI":"10.2165\/00002018-200023060-00004"},{"doi-asserted-by":"publisher","key":"2025121410003418000_11.8.e045948.11","DOI":"10.1002\/pds.677"},{"doi-asserted-by":"crossref","unstructured":"Poluzzi E et al . Data mining techniques in pharmacovigilance: analysis of the publicly accessible FDA adverse event reporting system (AERS), in data mining applications in engineering and medicine. IntechOpen 2012.","key":"2025121410003418000_11.8.e045948.12","DOI":"10.5772\/50095"},{"doi-asserted-by":"publisher","key":"2025121410003418000_11.8.e045948.13","DOI":"10.1002\/pds.771"},{"doi-asserted-by":"publisher","key":"2025121410003418000_11.8.e045948.14","DOI":"10.1002\/pds.1742"},{"doi-asserted-by":"publisher","key":"2025121410003418000_11.8.e045948.15","DOI":"10.1002\/pds.1001"},{"key":"2025121410003418000_11.8.e045948.16","doi-asserted-by":"crossref","first-page":"564","DOI":"10.3349\/ymj.2017.58.3.564","article-title":"Signal detection of imipenem compared to other drugs from Korea adverse event reporting system database","volume":"58","author":"Park","year":"2017","journal-title":"Yonsei Med J"},{"unstructured":"Group, E.E.W . Guideline on the use of statistical signal detection methods in the eudravigilance data analysis system. London: European Medicines Agency, 2006.","key":"2025121410003418000_11.8.e045948.17"},{"doi-asserted-by":"publisher","key":"2025121410003418000_11.8.e045948.18","DOI":"10.1002\/pds.668"},{"doi-asserted-by":"publisher","key":"2025121410003418000_11.8.e045948.19","DOI":"10.1136\/bmj.b2921"},{"unstructured":"Pharmaceuticals and Medical Devices Agency (PMDA) . YAZ TAB case report details, 2016. Available: https:\/\/www.pmda.go.jp\/files\/000153603.pdf [Accessed 14 Jun 2019].","key":"2025121410003418000_11.8.e045948.20"},{"key":"2025121410003418000_11.8.e045948.21","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1055\/s-0037-1613958","article-title":"Effects on coagulation of levonorgestrel- and desogestrel-containing low dose oral contraceptives: a cross-over study","volume":"84","author":"Middeldorp","year":"2000","journal-title":"Thromb Haemost"},{"key":"2025121410003418000_11.8.e045948.22","doi-asserted-by":"crossref","first-page":"1527","DOI":"10.1056\/NEJM200105173442007","article-title":"Oral contraceptives and the risk of venous thrombosis","volume":"344","author":"Vandenbroucke","year":"2001","journal-title":"N Engl J Med Overseas Ed"},{"doi-asserted-by":"publisher","key":"2025121410003418000_11.8.e045948.23","DOI":"10.1186\/s12905-020-01121-3"},{"unstructured":"Korea Pharmaceutical Information Center . Spironolactone. Available: http:\/\/www.health.kr\/searchDrug\/search_detail.asp [Accessed 14 Jun 2019].","key":"2025121410003418000_11.8.e045948.24"},{"doi-asserted-by":"publisher","key":"2025121410003418000_11.8.e045948.25","DOI":"10.1016\/S0010-7824(00)00133-5"},{"key":"2025121410003418000_11.8.e045948.26","doi-asserted-by":"crossref","first-page":"609","DOI":"10.1016\/S0015-0282(16)38469-2","article-title":"A placebo-controlled double-blind crossover investigation of the side effects attributed to oral contraceptives","volume":"22","author":"Goldzieher","year":"1971","journal-title":"Fertil Steril"},{"doi-asserted-by":"publisher","key":"2025121410003418000_11.8.e045948.27","DOI":"10.1001\/jama.1990.03440130073028"},{"doi-asserted-by":"publisher","key":"2025121410003418000_11.8.e045948.28","DOI":"10.1007\/s002280050498"},{"unstructured":"United Nations, Department of Economic and Social Affairs, Population Division . Contraceptive use by method 2019. Data Booklet (ST\/ESA\/SER.A\/435), 2019.","key":"2025121410003418000_11.8.e045948.29"},{"doi-asserted-by":"publisher","key":"2025121410003418000_11.8.e045948.30","DOI":"10.1002\/ajh.21059"},{"doi-asserted-by":"publisher","key":"2025121410003418000_11.8.e045948.31","DOI":"10.1136\/jfprhc-2013-100724"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2020-045948","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T18:00:45Z","timestamp":1765735245000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2020-045948"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,8]]},"references-count":31,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2021,8,13]]},"published-print":{"date-parts":[[2021,8]]}},"alternative-id":["10.1136\/bmjopen-2020-045948"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2020-045948","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"type":"print","value":"2044-6055"},{"type":"electronic","value":"2044-6055"}],"subject":[],"published":{"date-parts":[[2021,8]]}}}