Platinum drugs-related safety profile: The latest five-year analysis from FDA adverse event reporting system data

Feng, Guowen; Zhou, Xiaodan; Chen, Jia; Li, Dan; Chen, Li

doi:10.3389/fonc.2022.1012093

Cited by 8 publications

(4 citation statements)

References 41 publications

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“…5 Limitations of the study AE signal detection addresses the limitations of drug package inserts, such as delays in reporting, uncertainty, and incompleteness, by leveraging extensive data from spontaneous AE report databases to better reflect the drug's safety profile (Feng et al, 2023). However, the reliance on the FAERS database, which primarily includes U.S. reports, introduces potential biases (Mai et al, 2015).…”

Section: Discussionmentioning

confidence: 99%

Post-marketing risk analysis of bendamustine: a real-world approach based on the FAERS database

Li,

Zhang,

et al. 2024

Front. Pharmacol.

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Objective: Bendamustine was approved for treating chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma. Despite its therapeutic benefits, the long-term safety of bendamustine in a large population remains inadequately understood. This study evaluates the adverse events (AEs) associated with bendamustine, using a real-world pharmacovigilance database to support its clinical application.Methods: We conducted a post-marketing risk analysis to assess the association between bendamustine and its AEs. Data were extracted from the US FDA’s Adverse Event Reporting System (FAERS), covering the period from January 2017 to September 2023. The characteristics of bendamustine-associated AEs and the onset time were further analyzed. Statistical analysis was performed using MYSQL 8.0, Navicat Premium 15, Microsoft EXCEL 2016, and Minitab 21.0.Results: 9,461,874 reports were collected from the FAERS database, 9,131 identified bendamustine as the “primary suspected” drug. We identified 331 significant disproportionality preferred terms (PTs). Common AEs included pyrexia, neutropenia, infusion site reaction, progressive multifocal leukoencephalopathy (PML), injection site vasculitis, and pneumonia—all documented on bendamustine’s label. Notably, 16 unexpected and significant AEs were discovered, including hypogammaglobulinemia, which is concerning due to its potential to increase infection susceptibility following bendamustine treatment. Other significant findings were anaphylactic reactions, PML, and cutaneous malignancies, suggesting updates to the drug’s label may be necessary. Physicians should monitor for neurological and skin changes in patients and discontinue treatment if PML is suspected. Moreover, the median onset time for bendamustine-associated AEs was 13 days, with an interquartile range [IQR] of 0–59 days, predominantly occurring on the first day post-initiation. The β of bendamustine-related AEs suggested risk reduction over time.Conclusion: Our study uncovered some potential pharmacovigilance signals for bendamustine, providing important insights for its safe and effective clinical use.

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Section: Discussionmentioning

confidence: 99%

Post-marketing risk analysis of bendamustine: a real-world approach based on the FAERS database

Li,

Zhang,

et al. 2024

Front. Pharmacol.

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“…Platinum drugs mainly exert antitumour effects by affecting the DNA structure due to their molecular structure characteristics. With the wide application of platinum drugs in antitumour therapy, the incidence of platinum adverse drug events (ADEs) remains high, and the occurrence of different platinum ADEs is inconsistent, with cisplatin having stronger digestive and nephrotoxicity, carboplatin haematotoxicity being obvious, and neurotoxicity being more common with oxaliplatin 22 . Plant alkaloids and natural medicines have a broad antitumour spectrum and good antitumour activity, but because of widespread clinical use makes adverse reactions also increasing, most natural product-based anticancer drugs have adequate adverse reactions, mainly haematotoxicity, alopecia toxicity, neurotoxicity and cardiotoxicity 23 .Therefore, when using antineoplastic drugs, it is necessary to fully understand the characteristics of the drug and the possible toxic side effects, to strictly follow the instructions of the drug to formulate the dosing plan and take appropriate pretreatment measures, and to do good monitoring during the use of the drug as well as preparing for the treatment of ADRs when they are detected.…”

Section: Discussionmentioning

confidence: 99%

Trends in adverse drug reactions between 2011 and 2022 in a tertiary hospital in China through retrospective analysis

Liu,

Yang,

et al. 2023

Preprint

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Adverse drug reactions (ADRs) are unavoidable phenomena in the process of medication administration and can easily cause harm to patients. In order to understand the characteristics and patterns of ADRs, this article analyses the ADR reported by a tertiary hospital in China from 2011 and 2022. We retrospectively analyzed the trends of ADRs over these 10 years, including the distribution of ADRs, basic patient profiles, evaluation of the association of ADRs, route of administration, classification of drugs, and organs/systems involved in the ADRs. From 2011 to 2022, a total of 7,367 ADRs were reported. Over this 10-year period, the proportion of infants has been decreasing, and the rate of the juvenile group and the senior citizen has been increasing. The highest number of ADRs occurred via intravenous infusion. Among the organs/systems involved in adverse drug reactions, the skin and its accessories were mostly damaged, but the rate of ADRs in blood system increased significantly. Antibacterial drugs were the first cause of adverse drug reactions, followed by anti-tumor drugs. Through the changes related to ADRs in the past 10 years, we need to pay more attention to the adverse drug reactions caused by drugs, and further strengthen the monitoring of ADRs to reduce the occurrence of ADRs, and decrease the damage caused by adverse drug reactions, to ensure the life and health of patients.

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“…Platinum complexes such as oxaliplatin, cisplatin, carboplatin, etc. are currently 70%–80% likely to be utilized in clinical chemotherapy or combined chemotherapy for tumor illnesses ( Xue et al, 2021 ; Feng et al, 2023 ). Moreover, there are many adverse reactions/events caused by chemotherapy drugs for many reasons, including gender, age, underlying disease, dosage, narrow drug treatment window, etc.…”

Section: Discussionmentioning

confidence: 99%

Analysis of adverse drug reactions/events of cancer chemotherapy and the potential mechanism of Danggui Buxue decoction against bone marrow suppression induced by chemotherapy

Yan

Zhu

et al. 2023

Front. Pharmacol.

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Objective: To analyze the clinical characteristics of adverse reactions/events based on chemotherapy in cancer patients, and then explore the potential mechanism of Danggui Buxue Decoction (DBD) against chemotherapy-induced bone marrow suppression (BMS).Methods: Retrospectively collected and evaluated were the clinical data of patients in a hospital who experienced adverse reactions/events brought on by chemotherapeutic medications between 2015 and 2022. We explored the potential mechanism of DBD against BMS using network pharmacology based on the findings of the adverse reactions/events analysis.Results: 151 instances (72.25%) experienced adverse reactions/events from a single chemotherapy medication. Besides, platinum-based medications produced the most unfavorable effects. The study also found that chemotherapy caused the highest number of cases of BMS, including platinum drugs. Consequently, BMS is the most prevalent adverse reaction disease caused by chemotherapy found in this part. According to network pharmacology findings, DBD can prevent BMS primarily involving 1,510 primary targets and 19 key active ingredients. Based on the enrichment analysis, PI3K-AKT, TNF, MAPK, and IL-17 signaling pathways made up the majority of the DBD-resisting BMS pathways. Molecular docking displayed that kaempferol, the major active ingredient of DBD, had the highest binding energy (−10.08 kJ mol-1) with PTGS2 (a key target of BMS).Conclusion: Cancer patients who received chemotherapy had a risk to develop BMS. Regular blood tests should be performed while taking medicine; early discovery and treatment can reduce a patient’s risk of experiencing adverse reactions/events. Additionally, this study demonstrated that DBD, through a variety of targets and pathways, may be crucial in avoiding BMS.

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Platinum drugs-related safety profile: The latest five-year analysis from FDA adverse event reporting system data

Cited by 8 publications

References 41 publications

Post-marketing risk analysis of bendamustine: a real-world approach based on the FAERS database

Post-marketing risk analysis of bendamustine: a real-world approach based on the FAERS database

Trends in adverse drug reactions between 2011 and 2022 in a tertiary hospital in China through retrospective analysis

Analysis of adverse drug reactions/events of cancer chemotherapy and the potential mechanism of Danggui Buxue decoction against bone marrow suppression induced by chemotherapy

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