PMID- 38032065
OWN - NLM
STAT- Publisher
LR  - 20231205
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
DP  - 2023 Nov 30
TI  - A real-world analysis of safety profile of selexipag by using FDA adverse Event 
      Reporting System (FAERS).
PG  - 1-12
LID - 10.1080/14740338.2023.2290633 [doi]
AB  - BACKGROUND: The current investigation sought to conduct a real-world analysis of 
      adverse events (AEs) associated with selexipag by utilizing data from the Food 
      and Drug Administration Adverse Event Reporting System (FAERS). METHODS: The 
      Reporting Odds Ratios (ROR) and the Medicines Healthcare Products Regulatory 
      Agency (MHRA) method were employed to assess the potential associations between 
      selexipag and AEs. Case reports of adverse drug reaction (ADR) related to 
      selexipag were systematically sourced from PubMed, Embase, and Web of Science 
      databases. RESULTS: Our analysis identified 281 Preferred Terms (PTs) signals 
      across 20 System Organ Classes (SOCs) were found to meet the screening threshold. 
      The most common AEs were consistent with instructions, randomized controlled 
      trials (RCTs), and case reports. Of significant note, unexpected AEs principally 
      target SOCs of infections and infestations, blood and lymphatic system, renal and 
      urinary disorders, hepatobiliary disorders, including pneumonia, metapneumovirus, 
      decreased hemoglobin. transfusion, iron-deficiency anemia, dialysis hypotension, 
      abnormal creatinine renal clearance, liver function test increased, hepatic 
      function abnormal, hepatic enzyme increased. Within the pediatric population, 
      unexpected signals such as pyrexia, pneumonia, and intussusception necessitate 
      special precautionary measures. CONCLUSIONS: The findings contribute valuable 
      insights to clinical practice, reinforcing the importance of vigilant monitoring, 
      and can be instrumental in guiding both therapeutic applications and safety 
      assessments of this particular medication.
FAU - Zhao, Jie
AU  - Zhao J
AD  - Department of Pharmacy, Tongling People's Hospital, Tongling, Anhui Province, 
      China.
FAU - Wang, Mei
AU  - Wang M
AD  - Department of Pharmacy, Tongling Sixth People's Hospital, Tongling, Anhui 
      Province, China.
FAU - Yu, Qing
AU  - Yu Q
AD  - Department of Pharmacy, Tongling People's Hospital, Tongling, Anhui Province, 
      China.
FAU - Yang, Yi
AU  - Yang Y
AD  - Department of Infection, The First Affiliated Hospital Of Anhui Medical 
      University, Hefei, Anhui Province, China.
FAU - Zhang, Bin
AU  - Zhang B
AD  - Department of Cardiovascular, Tongling People's Hospital, Tongling, Anhui 
      Province, China.
FAU - Zhan, Sanhua
AU  - Zhan S
AD  - Department of Pharmacy, Tongling People's Hospital, Tongling, Anhui Province, 
      China.
LA  - eng
PT  - Journal Article
DEP - 20231130
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
SB  - IM
OTO - NOTNLM
OT  - FAERS
OT  - Selexipag
OT  - adverse events
OT  - case reports
OT  - safety profile
EDAT- 2023/11/30 12:42
MHDA- 2023/11/30 12:42
CRDT- 2023/11/30 07:53
PHST- 2023/11/30 12:42 [pubmed]
PHST- 2023/11/30 12:42 [medline]
PHST- 2023/11/30 07:53 [entrez]
AID - 10.1080/14740338.2023.2290633 [doi]
PST - aheadofprint
SO  - Expert Opin Drug Saf. 2023 Nov 30:1-12. doi: 10.1080/14740338.2023.2290633.