PMID- 37555411
OWN - NLM
STAT- MEDLINE
DCOM- 20231102
LR  - 20231106
IS  - 1998-3751 (Electronic)
IS  - 0253-7613 (Print)
IS  - 0253-7613 (Linking)
VI  - 55
IP  - 3
DP  - 2023 May-Jun
TI  - Safety signals of albumin-bound paclitaxel: Data mining of the Food and Drug 
      Administration adverse event reporting system.
PG  - 167-173
LID - 10.4103/ijp.ijp_640_22 [doi]
AB  - BACKGROUND: With the extensive application of paclitaxel for injection 
      (albumin-bound), its adverse reactions have also received increasing attention. 
      AIM: This study aims to provide a reference for the safe use of albumin-bound 
      paclitaxel in clinical practice; adverse drug events signals of albumin-bound 
      paclitaxel were reviewed and identified by data mining of the Food and Drug 
      Administration (FDA) adverse event reporting system (FAERS). METHODS: The 
      reporting odds ratio method was used for the quantitative detection of signals 
      from the data in the FDA public data program (OpenFDA) during 2004-2019 for the 
      albumin-bound paclitaxel. RESULTS: According to the OpenFDA, 1659 adverse events 
      (AEs) were identified for albumin-bound paclitaxel. AEs were mostly observed in 
      females rather than males, aged 45-64 years. AEs involved 17 system organ 
      classes, mainly blood and lymphatic, gastrointestinal, hepatobiliary, 
      respiratory, thoracic, and mediastinal systems, and general AEs. Safety signals 
      were found in 20 unexpected adverse drug reactions which are not listed on drug 
      labels, mainly including macular edema and lymphopenia. CONCLUSION: Identifying 
      and evaluating albumin-bound paclitaxel-associated AEs signals by mining FAERS 
      may help evaluate the safety profiles of albumin-bound paclitaxel and reduce the 
      risk of medical treatment. In the clinical application of albumin-bound 
      paclitaxel in addition to the adverse reactions mentioned in the drug 
      instructions, lymphocyte changes should be paid close attention to, and eye 
      monitoring should be conducted regularly to avoid drug withdrawal or organ damage 
      caused by adverse reactions.
FAU - Wang, Yuwei
AU  - Wang Y
AD  - Radiation Oncology Center, Chongqing University Cancer Hospital, Chongqing, 
      China.
FAU - Liu, Xiao
AU  - Liu X
AD  - Department of Gastrointestinal Surgery, The Fifth People's Hospital of Chongqing, 
      Chongqing, China.
LA  - eng
PT  - Journal Article
PL  - India
TA  - Indian J Pharmacol
JT  - Indian journal of pharmacology
JID - 7902477
RN  - 0 (Albumin-Bound Paclitaxel)
RN  - P88XT4IS4D (Paclitaxel)
RN  - 0 (Albumins)
SB  - IM
MH  - Male
MH  - Female
MH  - United States
MH  - Humans
MH  - *Albumin-Bound Paclitaxel/adverse effects
MH  - United States Food and Drug Administration
MH  - Paclitaxel/adverse effects
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Albumins/adverse effects
MH  - Data Mining
MH  - Adverse Drug Reaction Reporting Systems
PMC - PMC10501543
OTO - NOTNLM
OT  - Adverse events
OT  - Food and Drug Administration adverse event reporting system
OT  - albumin-bound paclitaxel
OT  - signals
COIS- None
EDAT- 2023/08/09 06:43
MHDA- 2023/08/09 06:44
PMCR- 2023/05/01
CRDT- 2023/08/09 05:59
PHST- 2023/08/09 06:44 [medline]
PHST- 2023/08/09 06:43 [pubmed]
PHST- 2023/08/09 05:59 [entrez]
PHST- 2023/05/01 00:00 [pmc-release]
AID - Indian J Pharmacol_2023_55_3_167_382575 [pii]
AID - IJPharm-55-167 [pii]
AID - 10.4103/ijp.ijp_640_22 [doi]
PST - ppublish
SO  - Indian J Pharmacol. 2023 May-Jun;55(3):167-173. doi: 10.4103/ijp.ijp_640_22.