PMID- 36702463
OWN - NLM
STAT- Publisher
LR  - 20240216
IS  - 1365-2125 (Electronic)
IS  - 0306-5251 (Linking)
DP  - 2023 Jan 26
TI  - A post-marketing pharmacovigilance study of avapritinib: Adverse event data 
      mining and analysis based on the United States Food and Drug Administration 
      Adverse Event Reporting System database.
LID - 10.1111/bcp.15673 [doi]
AB  - AIMS: Avapritinib was first approved by the FDA in January 2020 and represents 
      the first precision-targeted drug for gastrointestinal stromal tumours. However, 
      there is a lack of large-scale data relating to adverse events (AEs) related to 
      its use. We aimed to explore the avapritinib-related AEs in real-world practice 
      based on the post-marketing data. METHODS: We extracted all avapritinib-related 
      reports submitted to the FDA Adverse Event Reporting System (FAERS) by June 2022. 
      Based on disproportionality analysis and Bayesian analysis, we then calculated 
      the reporting odds ratio (ROR), proportional reporting ratio (PRR), information 
      component (IC) and empirical Bayes geometric mean (EBGM) to evaluate whether 
      there is a significant association between avapritinib and AEs. Gender, age and 
      time to onset were comparable between haemorrhage/non-haemorrhage, 
      serious/non-serious, death/non-death AEs, respectively. RESULTS: In total, 3120 
      cases related to avapritinib were documented in the FAERS database, and 44% were 
      reported within 30 days of commencing avapritinib. A total of 331 different AE 
      signals were detected, and no significant differences between males and females 
      was identified. Although the number of AEs associated with an abnormal skin 
      texture and executive dysfunction was small, the signal intensity is high, 
      suggesting that these events are strongly correlated with avapritinib. Subgroup 
      analysis showed that elderly male patients were more likely to suffer from 
      serious AEs compared to females (P < .01), but there was no significant 
      difference between the haemorrhage group and the non-haemorrhage group. Analysis 
      of fatalities due to avapritinib-related AEs indicated that sex, age and 
      time-to-onset were all significantly related to death (P < .05). CONCLUSION: Our 
      study provides a more precise description of the incidence and characteristics of 
      AEs after using avapritinib, clinicians should be particularly careful when 
      prescribing avapritinib to elderly male patients, especially within the 30 days.
CI  - (c) 2023 British Pharmacological Society.
FAU - Rong, Li
AU  - Rong L
AD  - Department of Pharmacy, The First Affiliated Hospital of Bengbu Medical College, 
      Bengbu, China.
AD  - School of Pharmacy, Bengbu Medical College, Bengbu, China.
FAU - Xie, Mengyuan
AU  - Xie M
AD  - Department of Pharmacy, The First Affiliated Hospital of Bengbu Medical College, 
      Bengbu, China.
AD  - School of Pharmacy, Bengbu Medical College, Bengbu, China.
FAU - Jiang, Manxue
AU  - Jiang M
AD  - Department of Pharmacy, The First Affiliated Hospital of Bengbu Medical College, 
      Bengbu, China.
AD  - School of Pharmacy, Bengbu Medical College, Bengbu, China.
FAU - Qiu, Hongyu
AU  - Qiu H
AD  - Department of Pharmacy, The First Affiliated Hospital of Bengbu Medical College, 
      Bengbu, China.
AD  - School of Pharmacy, Bengbu Medical College, Bengbu, China.
FAU - Kong, Lingti
AU  - Kong L
AUID- ORCID: 0000-0003-0769-9363
AD  - Department of Pharmacy, The First Affiliated Hospital of Bengbu Medical College, 
      Bengbu, China.
AD  - School of Pharmacy, Bengbu Medical College, Bengbu, China.
AD  - Institute of Emergency and Critical Care Medicine, The First Affifiliated 
      Hospital of Bengbu Medical College, Bengbu, China.
LA  - eng
GR  - bydc2021069/College students' innovation and entrepreneurship training pro-gram/
GR  - 2022zyxwjxalk148/New era education quality project-postgraduate education of 
      Anhui Province/
GR  - by51201316/Talent training plan of Bengbu Medical College/
PT  - Journal Article
DEP - 20230126
PL  - England
TA  - Br J Clin Pharmacol
JT  - British journal of clinical pharmacology
JID - 7503323
SB  - IM
OTO - NOTNLM
OT  - FAERS
OT  - adverse events
OT  - avapritinib
OT  - data mining
OT  - pharmacovigilance
EDAT- 2023/01/27 06:00
MHDA- 2023/01/27 06:00
CRDT- 2023/01/26 19:53
PHST- 2023/01/09 00:00 [revised]
PHST- 2022/11/04 00:00 [received]
PHST- 2023/01/16 00:00 [accepted]
PHST- 2023/01/27 06:00 [pubmed]
PHST- 2023/01/27 06:00 [medline]
PHST- 2023/01/26 19:53 [entrez]
AID - 10.1111/bcp.15673 [doi]
PST - aheadofprint
SO  - Br J Clin Pharmacol. 2023 Jan 26. doi: 10.1111/bcp.15673.