Safety signals of albumin-bound paclitaxel Data mining of the Food and Drug Administration adverse event reporting system
Publication details: Mumbai Wolter Kluwer 2023Edition: Vol.55(3), May-JunDescription: 167-173pSubject(s): Online resources: In: Indian Journal of PharmacologySummary: 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.| Item type | Current library | Status | Barcode | |
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School of Pharmacy Archieval Section | Not for loan | 2024-0382 |
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.
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