PMID- 37578751
OWN - NLM
STAT- MEDLINE
DCOM- 20231129
LR  - 20231129
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 22
IP  - 11
DP  - 2023 Jul-Dec
TI  - A real-world disproportionality analysis of ospemifene: data mining of the public 
      version of FDA adverse event reporting system.
PG  - 1133-1142
LID - 10.1080/14740338.2023.2247971 [doi]
AB  - BACKGROUND: Ospemifene has been authorized for the treatment of vulvovaginal 
      atrophy (VVA). This study wasto evaluate adverse events (AEs) associated with 
      ospemifene by data mining the US Food and Drug Administration Adverse Event 
      Reporting System (FAERS). METHODS: The signals of AEs linked to ospemifene were 
      measured using disproportionality analyses, such as the reporting odds ratio 
      (ROR), the proportional reporting ratio (PRR), the Bayesian confidence 
      propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker 
      (MGPS) algorithms. RESULTS: There were 2283 events of ospemifene being the 
      'primary suspected (PS)' AE out of the 12,692,824 reports from the FAERS 
      database. Ospemifene-induced AEs hit 25 organ systems. There were 726 severely 
      disproportional preferred terms (PTs) that complied with the four algorithms. The 
      investigation turned up a number of anticipated adverse drug reactions (ADRs), 
      and significant unanticipated ADRs linked to eye and renal problems were found, 
      indicating potential side effects not yet included in the prescription 
      instructions. CONCLUSION: We detected novel AEs signals for ospemifene, and the 
      results of our investigation were compatible with clinical observations. This 
      suggests that further prospective clinical trials are required to confirm these 
      findings and demonstrate their link. Our findings might be useful supporting data 
      for ospemifene safety research in the future.
FAU - Wen, Haixiao
AU  - Wen H
AD  - Department of Obstetrics and Gynecology, The First Affiliated Hospital of 
      Zhengzhou University, Zhengzhou, Henan, China.
FAU - Lu, Chong
AU  - Lu C
AD  - Department of Integration of Western and Traditional Medicine, Obstetrics and 
      Gynecology Hospital of Fudan University, Shanghai, China.
FAU - Zhang, Meng
AU  - Zhang M
AD  - Department of Integration of Western and Traditional Medicine, Obstetrics and 
      Gynecology Hospital of Fudan University, Shanghai, China.
FAU - Qi, Xingling
AU  - Qi X
AD  - Department of Integration of Western and Traditional Medicine, Obstetrics and 
      Gynecology Hospital of Fudan University, Shanghai, China.
LA  - eng
PT  - Journal Article
DEP - 20230824
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - B0P231ILBK (Ospemifene)
SB  - IM
MH  - United States
MH  - Humans
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Bayes Theorem
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology/etiology
MH  - Data Mining
MH  - United States Food and Drug Administration
OTO - NOTNLM
OT  - BCPNN
OT  - EBGM
OT  - PRR
OT  - ROR
OT  - ospemifene
EDAT- 2023/08/14 12:42
MHDA- 2023/11/29 06:43
CRDT- 2023/08/14 11:33
PHST- 2023/11/29 06:43 [medline]
PHST- 2023/08/14 12:42 [pubmed]
PHST- 2023/08/14 11:33 [entrez]
AID - 10.1080/14740338.2023.2247971 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2023 Jul-Dec;22(11):1133-1142. doi: 
      10.1080/14740338.2023.2247971. Epub 2023 Aug 24.