PMID- 32686733
OWN - NLM
STAT- MEDLINE
DCOM- 20201221
LR  - 20210720
IS  - 2045-2322 (Electronic)
IS  - 2045-2322 (Linking)
VI  - 10
IP  - 1
DP  - 2020 Jul 20
TI  - Ovary and uterus related adverse events associated with statin use: an analysis 
      of the FDA Adverse Event Reporting System.
PG  - 11955
LID - 10.1038/s41598-020-68906-2 [doi]
LID - 11955
AB  - Experimental studies have demonstrated statin-induced toxicity for ovary and 
      uterus. However, the safety of statins on the functions of ovary and uterus in 
      real-world clinical settings remains unknown. The aim of this study was to 
      identify ovary and uterus related adverse events (AEs) associated with statin use 
      by analyzing data from FDA Adverse Event Reporting System (FAERS). We used 
      OpenVigil 2.1 to query FAERS database. Ovary and uterus related AEs were defined 
      by 383 Preferred Terms, which could be classified into ten aspects. 
      Disproportionality analysis was performed to assess the association between AEs 
      and statin use. Our results suggest that statin use may be associated with a 
      series of ovary and uterus related AEs. These AEs are involved in ovarian cysts 
      and neoplasms, uterine neoplasms, cervix neoplasms, uterine disorders (excl 
      neoplasms), cervix disorders (excl neoplasms), endocrine disorders of gonadal 
      function, menstrual cycle and uterine bleeding disorders, menopause related 
      conditions, and sexual function disorders. Moreover, there are variabilities in 
      the types and signal strengths of ovary and uterus related AEs across individual 
      statins. According to our findings, the potential ovary and uterus related AEs of 
      statins should attract enough attention and be closely monitored in future 
      clinical practice.
FAU - Jiao, Xue-Feng
AU  - Jiao XF
AD  - Department of Pharmacy, West China Second University Hospital, Sichuan 
      University, Chengdu, 610041, Sichuan, China.
AD  - Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan 
      University, Chengdu, 610041, Sichuan, China.
AD  - Key Laboratory of Birth Defects and Related Diseases of Women and Children 
      (Sichuan University), Ministry of Education, Chengdu, 610041, Sichuan, China.
AD  - West China School of Medicine, Sichuan University, Chengdu, 610041, Sichuan, 
      China.
FAU - Li, Hai-Long
AU  - Li HL
AD  - Department of Pharmacy, West China Second University Hospital, Sichuan 
      University, Chengdu, 610041, Sichuan, China.
AD  - Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan 
      University, Chengdu, 610041, Sichuan, China.
AD  - Key Laboratory of Birth Defects and Related Diseases of Women and Children 
      (Sichuan University), Ministry of Education, Chengdu, 610041, Sichuan, China.
FAU - Jiao, Xue-Yan
AU  - Jiao XY
AD  - Xinxiang Medical University, Xinxiang, 453000, Henan, China.
FAU - Guo, Yuan-Chao
AU  - Guo YC
AD  - Department of Pharmacy, West China Second University Hospital, Sichuan 
      University, Chengdu, 610041, Sichuan, China.
AD  - Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan 
      University, Chengdu, 610041, Sichuan, China.
AD  - Key Laboratory of Birth Defects and Related Diseases of Women and Children 
      (Sichuan University), Ministry of Education, Chengdu, 610041, Sichuan, China.
FAU - Zhang, Chuan
AU  - Zhang C
AD  - Department of Pharmacy, West China Second University Hospital, Sichuan 
      University, Chengdu, 610041, Sichuan, China.
AD  - Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan 
      University, Chengdu, 610041, Sichuan, China.
AD  - Key Laboratory of Birth Defects and Related Diseases of Women and Children 
      (Sichuan University), Ministry of Education, Chengdu, 610041, Sichuan, China.
FAU - Yang, Chun-Song
AU  - Yang CS
AD  - Department of Pharmacy, West China Second University Hospital, Sichuan 
      University, Chengdu, 610041, Sichuan, China.
AD  - Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan 
      University, Chengdu, 610041, Sichuan, China.
AD  - Key Laboratory of Birth Defects and Related Diseases of Women and Children 
      (Sichuan University), Ministry of Education, Chengdu, 610041, Sichuan, China.
FAU - Zeng, Li-Nan
AU  - Zeng LN
AD  - Department of Pharmacy, West China Second University Hospital, Sichuan 
      University, Chengdu, 610041, Sichuan, China.
AD  - Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan 
      University, Chengdu, 610041, Sichuan, China.
AD  - Key Laboratory of Birth Defects and Related Diseases of Women and Children 
      (Sichuan University), Ministry of Education, Chengdu, 610041, Sichuan, China.
FAU - Bo, Zhen-Yan
AU  - Bo ZY
AD  - Department of Pharmacy, West China Second University Hospital, Sichuan 
      University, Chengdu, 610041, Sichuan, China.
AD  - Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan 
      University, Chengdu, 610041, Sichuan, China.
AD  - Key Laboratory of Birth Defects and Related Diseases of Women and Children 
      (Sichuan University), Ministry of Education, Chengdu, 610041, Sichuan, China.
FAU - Chen, Zhe
AU  - Chen Z
AD  - Department of Pharmacy, West China Second University Hospital, Sichuan 
      University, Chengdu, 610041, Sichuan, China.
AD  - Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan 
      University, Chengdu, 610041, Sichuan, China.
AD  - Key Laboratory of Birth Defects and Related Diseases of Women and Children 
      (Sichuan University), Ministry of Education, Chengdu, 610041, Sichuan, China.
FAU - Song, Hai-Bo
AU  - Song HB
AD  - Center for Drug Reevaluation, National Medical Products Administration, Beijing, 
      100000, China. songhaibo@cdr-adr.org.cn.
FAU - Zhang, Ling-Li
AU  - Zhang LL
AD  - Department of Pharmacy, West China Second University Hospital, Sichuan 
      University, Chengdu, 610041, Sichuan, China. zhanglingli@scu.edu.cn.
AD  - Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan 
      University, Chengdu, 610041, Sichuan, China. zhanglingli@scu.edu.cn.
AD  - Key Laboratory of Birth Defects and Related Diseases of Women and Children 
      (Sichuan University), Ministry of Education, Chengdu, 610041, Sichuan, China. 
      zhanglingli@scu.edu.cn.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200720
PL  - England
TA  - Sci Rep
JT  - Scientific reports
JID - 101563288
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/*adverse effects/therapeutic use
MH  - Infant
MH  - Infant, Newborn
MH  - Middle Aged
MH  - Ovary/*drug effects/metabolism
MH  - Signal Transduction/drug effects
MH  - United States
MH  - United States Food and Drug Administration
MH  - Uterus/*drug effects/metabolism
MH  - Young Adult
PMC - PMC7371681
COIS- The authors declare no competing interests.
EDAT- 2020/07/21 06:00
MHDA- 2020/12/22 06:00
PMCR- 2020/07/20
CRDT- 2020/07/21 06:00
PHST- 2020/04/13 00:00 [received]
PHST- 2020/07/01 00:00 [accepted]
PHST- 2020/07/21 06:00 [entrez]
PHST- 2020/07/21 06:00 [pubmed]
PHST- 2020/12/22 06:00 [medline]
PHST- 2020/07/20 00:00 [pmc-release]
AID - 10.1038/s41598-020-68906-2 [pii]
AID - 68906 [pii]
AID - 10.1038/s41598-020-68906-2 [doi]
PST - epublish
SO  - Sci Rep. 2020 Jul 20;10(1):11955. doi: 10.1038/s41598-020-68906-2.