Signal detection of drospirenone-containing oral contraceptives: a disproportionality analysis using the Korea Adverse Event Reporting System Database, 2008–2017
Objectives 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.Design A descriptive analysi...
| Główni autorzy: | , , , , , |
|---|---|
| Format: | Artykuł |
| Język: | English |
| Wydane: |
BMJ Publishing Group
2021-08-01
|
| Seria: | BMJ Open |
| Dostęp online: | https://bmjopen.bmj.com/content/11/8/e045948.full |
| _version_ | 1826945367837507584 |
|---|---|
| author | Ha-Lim Jeon Ju-Young Shin Seung-Ah Choe Yeri Lee Ahhyung Choi Yunha Noh |
| author_facet | Ha-Lim Jeon Ju-Young Shin Seung-Ah Choe Yeri Lee Ahhyung Choi Yunha Noh |
| author_sort | Ha-Lim Jeon |
| collection | DOAJ |
| description | Objectives 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.Design A descriptive analysis of claims data.Setting The Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System Database from 1 February 2008 to 31 December 2017.Outcome measures 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.Results 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.Conclusions 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. |
| first_indexed | 2025-02-17T20:53:55Z |
| format | Article |
| id | doaj.art-0cf3a901b9ee45daa1af2fa68c54a01a |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2025-02-17T20:53:55Z |
| publishDate | 2021-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-0cf3a901b9ee45daa1af2fa68c54a01a2024-12-09T04:20:09ZengBMJ Publishing GroupBMJ Open2044-60552021-08-0111810.1136/bmjopen-2020-045948Signal detection of drospirenone-containing oral contraceptives: a disproportionality analysis using the Korea Adverse Event Reporting System Database, 2008–2017Ha-Lim Jeon0Ju-Young Shin1Seung-Ah Choe2Yeri Lee3Ahhyung Choi4Yunha Noh5School of Pharmacy, Sungkyunkwan University, Suwon, Korea (the Republic of)School of Pharmacy, Sungkyunkwan University, Suwon, Korea (the Republic of)Korea University - Anam Campus, Seongbuk-gu, Korea (the Republic of)School of Pharmacy, Sungkyunkwan University, Suwon, Korea (the Republic of)School of Pharmacy, Sungkyunkwan University, Suwon, Korea (the Republic of)School of Pharmacy, Sungkyunkwan University, Suwon, Korea (the Republic of)Objectives 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.Design A descriptive analysis of claims data.Setting The Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System Database from 1 February 2008 to 31 December 2017.Outcome measures 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.Results 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.Conclusions 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.https://bmjopen.bmj.com/content/11/8/e045948.full |
| spellingShingle | Ha-Lim Jeon Ju-Young Shin Seung-Ah Choe Yeri Lee Ahhyung Choi Yunha Noh Signal detection of drospirenone-containing oral contraceptives: a disproportionality analysis using the Korea Adverse Event Reporting System Database, 2008–2017 BMJ Open |
| title | Signal detection of drospirenone-containing oral contraceptives: a disproportionality analysis using the Korea Adverse Event Reporting System Database, 2008–2017 |
| title_full | Signal detection of drospirenone-containing oral contraceptives: a disproportionality analysis using the Korea Adverse Event Reporting System Database, 2008–2017 |
| title_fullStr | Signal detection of drospirenone-containing oral contraceptives: a disproportionality analysis using the Korea Adverse Event Reporting System Database, 2008–2017 |
| title_full_unstemmed | Signal detection of drospirenone-containing oral contraceptives: a disproportionality analysis using the Korea Adverse Event Reporting System Database, 2008–2017 |
| title_short | Signal detection of drospirenone-containing oral contraceptives: a disproportionality analysis using the Korea Adverse Event Reporting System Database, 2008–2017 |
| title_sort | signal detection of drospirenone containing oral contraceptives a disproportionality analysis using the korea adverse event reporting system database 2008 2017 |
| url | https://bmjopen.bmj.com/content/11/8/e045948.full |
| work_keys_str_mv | AT halimjeon signaldetectionofdrospirenonecontainingoralcontraceptivesadisproportionalityanalysisusingthekoreaadverseeventreportingsystemdatabase20082017 AT juyoungshin signaldetectionofdrospirenonecontainingoralcontraceptivesadisproportionalityanalysisusingthekoreaadverseeventreportingsystemdatabase20082017 AT seungahchoe signaldetectionofdrospirenonecontainingoralcontraceptivesadisproportionalityanalysisusingthekoreaadverseeventreportingsystemdatabase20082017 AT yerilee signaldetectionofdrospirenonecontainingoralcontraceptivesadisproportionalityanalysisusingthekoreaadverseeventreportingsystemdatabase20082017 AT ahhyungchoi signaldetectionofdrospirenonecontainingoralcontraceptivesadisproportionalityanalysisusingthekoreaadverseeventreportingsystemdatabase20082017 AT yunhanoh signaldetectionofdrospirenonecontainingoralcontraceptivesadisproportionalityanalysisusingthekoreaadverseeventreportingsystemdatabase20082017 |