PMID- 36178002
OWN - NLM
STAT- MEDLINE
DCOM- 20230522
LR  - 20230522
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 22
IP  - 4
DP  - 2023 Apr
TI  - A pharmacovigilance analysis of FDA adverse event reporting system events for 
      romosozumab.
PG  - 339-342
LID - 10.1080/14740338.2023.2130891 [doi]
AB  - BACKGROUND: Romosozumab is a novel drug for the treatment of osteoporosis. The 
      adverse reactions of romosozumab still need to be explored. The FDA Adverse Event 
      Reporting System (FAERS) provides an enormous dataset for adverse events (AEs) 
      analysis. RESEARCH DESIGN AND METHODS: AEs registered in FAERS between January 
      2019 and December 2020 were collected for this study. The reporting odds ratio 
      (ROR) method was applied to analyze the AEs of romosozumab. The number of AEs >/=4 
      cases and ROR value 95% confidence interval (CI) lower limit >1 was considered 
      statistically significant. RESULTS: A total of 4,413,695 AEs were collected for 
      this study. There were 1,948 AEs related with romosozumab reported in FAERS. 
      There are 1851 AEs including 17 system classifications after filtered. Injection 
      site pain (ROR = 6.89, CI = 5.60, 8.48), cardiac failure (ROR = 12.62, CI = 9.85, 
      16.17), renal impairment (ROR = 9.11, CI = 6.98, 11.89), pneumonia (ROR = 1.53, 
      CI = 1.10, 2.21), blood alkaline phosphatase increased (ROR = 14.60, CI = 9.28, 
      22.97) were possible AEs after romosozumab application. CONCLUSIONS: Our study 
      provides an adverse reaction warning for the clinical application of romosozumab 
      and provides a real-world disproportionality analysis data support for the 
      possible AEs of romosozumab.
FAU - Chen, Zepeng
AU  - Chen Z
AD  - Department of Pharmacy, Sun-Yat-Sen Memorial Hospital, Sun Yat-sen University, 
      Guangzhou, Guangdong, China.
FAU - Li, Ming
AU  - Li M
AD  - Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen Memorial 
      Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
FAU - Li, Shuzhen
AU  - Li S
AD  - Department of Pharmacy, Liwan District Caihong Community Health Service Center, 
      Guangzhou, Guangdong, China.
FAU - Li, Yuxi
AU  - Li Y
AD  - Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen Memorial 
      Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
FAU - Wu, Junyan
AU  - Wu J
AD  - Department of Pharmacy, Sun-Yat-Sen Memorial Hospital, Sun Yat-sen University, 
      Guangzhou, Guangdong, China.
FAU - Qiu, Kaifeng
AU  - Qiu K
AD  - Department of Pharmacy, Sun-Yat-Sen Memorial Hospital, Sun Yat-sen University, 
      Guangzhou, Guangdong, China.
FAU - Yu, Xiaoxia
AU  - Yu X
AD  - Department of Pharmacy, Sun-Yat-Sen Memorial Hospital, Sun Yat-sen University, 
      Guangzhou, Guangdong, China.
FAU - Huang, Lin
AU  - Huang L
AUID- ORCID: 0000-0002-8285-2658
AD  - Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen Memorial 
      Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
FAU - Chen, Guanghui
AU  - Chen G
AD  - Department of Pharmacy, Sun-Yat-Sen Memorial Hospital, Sun Yat-sen University, 
      Guangzhou, Guangdong, China.
LA  - eng
PT  - Journal Article
DEP - 20221005
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 3VHF2ZD92J (romosozumab)
SB  - IM
MH  - United States
MH  - Humans
MH  - *Pharmacovigilance
MH  - Adverse Drug Reaction Reporting Systems
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - United States Food and Drug Administration
MH  - Databases, Factual
OTO - NOTNLM
OT  - FAERS
OT  - adverse events
OT  - reporting odds ratio
OT  - romosozumab
EDAT- 2022/10/01 06:00
MHDA- 2023/05/22 06:42
CRDT- 2022/09/30 06:12
PHST- 2023/05/22 06:42 [medline]
PHST- 2022/10/01 06:00 [pubmed]
PHST- 2022/09/30 06:12 [entrez]
AID - 10.1080/14740338.2023.2130891 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2023 Apr;22(4):339-342. doi: 10.1080/14740338.2023.2130891. 
      Epub 2022 Oct 5.