PMID- 36608646
OWN - NLM
STAT- MEDLINE
DCOM- 20230110
LR  - 20230119
IS  - 1482-1826 (Electronic)
IS  - 1482-1826 (Linking)
VI  - 25
DP  - 2022
TI  - Post-Marketing Safety of Vemurafenib: A Real-World Pharmacovigilance Study of the 
      FDA Adverse Event Reporting System.
PG  - 377-390
LID - 10.18433/jpps33020 [doi]
AB  - PURPOSE: Vemurafenib received approval for treatment of BRAF V600 variation 
      metastatic melanoma in August 2011. This study analyzed Vemurafenib-related 
      adverse events (AEs) to detect and characterize relevant safety signals using the 
      real-word-data through the Food and Drug Administration Adverse Event Reporting 
      System (FAERS). METHODS: Disproportionality analyses, including the reporting 
      odds ratio (ROR), the healthcare products regulatory agency (MHRA), the Bayesian 
      confidence propagation neural network (BCPNN), and the multiitem gamma Poisson 
      shrinker (MGPS) algorithms, were applied to quantify the signals of 
      vemurafenib-related AEs. RESULTS: Out of 8,042,244 reports gathered from the 
      FAERS, 9554 reports of vemurafenib as the 'primary suspected (PS)' AEs were 
      recognized. Vemurafenib-induced AEs occurrence targeted 23 system organ class 
      (SOC). A total of 138 significant disproportionality PTs was simultaneously 
      reserved according to the four algorithms. Unexpected significant AEs such as 
      sarcoidosis and kidney fibrosis might also occur. The median onset time of 
      vemurafenib-related AEs was 26 days (interquartile range [IQR] 8-97 days), and 
      most of the cases occurred within the first one and two months after vemurafenib 
      initiation. CONCLUSION: Our study detected potential new AEs signals and might 
      provide powerful support for clinical monitoring and risk identification of 
      vemurafenib.
FAU - Liu, Yanxin
AU  - Liu Y
AD  - Pengzhou People's Hospital.
FAU - Dong, Changjiang
AU  - Dong C
FAU - He, Xucheng
AU  - He X
FAU - Shu, Yamin
AU  - Shu Y
FAU - Wu, Pan
AU  - Wu P
FAU - Zou, Jian
AU  - Zou J
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - Switzerland
TA  - J Pharm Pharm Sci
JT  - Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian 
      Society for Pharmaceutical Sciences, Societe canadienne des sciences 
      pharmaceutiques
JID - 9807281
RN  - 207SMY3FQT (Vemurafenib)
SB  - IM
MH  - United States
MH  - Humans
MH  - Pharmacovigilance
MH  - Vemurafenib/adverse effects
MH  - Adverse Drug Reaction Reporting Systems
MH  - Bayes Theorem
MH  - *Melanoma/drug therapy
MH  - United States Food and Drug Administration
MH  - *Drug-Related Side Effects and Adverse Reactions
EDAT- 2023/01/08 06:00
MHDA- 2023/01/11 06:00
CRDT- 2023/01/07 16:00
PHST- 2023/01/07 16:00 [entrez]
PHST- 2023/01/08 06:00 [pubmed]
PHST- 2023/01/11 06:00 [medline]
AID - 10.18433/jpps33020 [doi]
PST - ppublish
SO  - J Pharm Pharm Sci. 2022;25:377-390. doi: 10.18433/jpps33020.