PMID- 34389561
OWN - NLM
STAT- MEDLINE
DCOM- 20210817
LR  - 20210831
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 11
IP  - 8
DP  - 2021 Aug 13
TI  - Signal detection of drospirenone-containing oral contraceptives: a 
      disproportionality analysis using the Korea Adverse Event Reporting System 
      Database, 2008-2017.
PG  - e045948
LID - 10.1136/bmjopen-2020-045948 [doi]
LID - e045948
AB  - 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.
CI  - (c) Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Lee, Yeri
AU  - Lee Y
AD  - School of Pharmacy, Sungkyunkwan University, Suwon, Korea (the Republic of).
FAU - Choi, Ahhyung
AU  - Choi A
AD  - School of Pharmacy, Sungkyunkwan University, Suwon, Korea (the Republic of).
FAU - Noh, Yunha
AU  - Noh Y
AD  - School of Pharmacy, Sungkyunkwan University, Suwon, Korea (the Republic of).
FAU - Jeon, Ha-Lim
AU  - Jeon HL
AD  - School of Pharmacy, Sungkyunkwan University, Suwon, Korea (the Republic of).
FAU - Choe, Seung-Ah
AU  - Choe SA
AUID- ORCID: 0000-0001-6270-5020
AD  - Department of Preventive Medicine, College of Medicine, Korea University, Seoul, 
      Korea (the Republic of).
FAU - Shin, Ju-Young
AU  - Shin JY
AUID- ORCID: 0000-0003-1010-7525
AD  - School of Pharmacy, Sungkyunkwan University, Suwon, Korea (the Republic of) 
      shin.jy@skku.edu.
AD  - Department of Clinical Research Design and Evaluation, Samsung Advanced Institute 
      for Health Sciences and Technology, Seoul, Korea (the Republic of).
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20210813
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
RN  - 0 (Androstenes)
RN  - 0 (Contraceptives, Oral)
RN  - 81K9V7M3A3 (Desogestrel)
RN  - N295J34A25 (drospirenone)
SB  - IM
MH  - Androstenes/adverse effects
MH  - *Contraceptives, Oral/adverse effects
MH  - *Desogestrel
MH  - Female
MH  - Humans
MH  - Republic of Korea
MH  - Risk Factors
PMC - PMC8365811
OTO - NOTNLM
OT  - adverse events
OT  - epidemiology
OT  - gynaecology
COIS- Competing interests: None declared.
EDAT- 2021/08/15 06:00
MHDA- 2021/08/18 06:00
PMCR- 2021/08/13
CRDT- 2021/08/14 05:48
PHST- 2021/08/14 05:48 [entrez]
PHST- 2021/08/15 06:00 [pubmed]
PHST- 2021/08/18 06:00 [medline]
PHST- 2021/08/13 00:00 [pmc-release]
AID - bmjopen-2020-045948 [pii]
AID - 10.1136/bmjopen-2020-045948 [doi]
PST - epublish
SO  - BMJ Open. 2021 Aug 13;11(8):e045948. doi: 10.1136/bmjopen-2020-045948.