A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for venetoclax

Yang, Yang; Shu, Yamin; Chen, Guosong; Yin, Yanchao; Li, Feie; Li, Juan

doi:10.1371/journal.pone.0278725

Cited by 7 publications

(7 citation statements)

References 48 publications

(65 reference statements)

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“…Neutropenia was common (40–50%), and the occurrence of grade ≥ 3 neutropenia was associated with risk of pneumonia. Infections accounted for nearly a quarter of venetoclax-related adverse events (pneumonia was the most common), which is consistent with the immunosuppression associated with the underlying CLL [ 33 ]. Most adverse events can be managed with additional supporting medication (e.g., nausea with ondansetron or prochlorperazine; diarrhea with loperamide).…”

Section: Clinical Trials and Real-world Studies Of Venetoclax In Pati...mentioning

confidence: 77%

“…In a real-world pharmacovigilance study of venetoclax-related adverse events in patients with CLL or other hematologic malignancies using the FDA Adverse Event Reporting System database (19,107 cases of adverse events) [ 33 ], the median time to occurrence of adverse events was 31 days (range, 7–131 days). Half of the events occurred in the first 30 days and approximately 70% in the first 3 months.…”

Section: Clinical Trials and Real-world Studies Of Venetoclax In Pati...mentioning

confidence: 99%

“…TLS risk could be predicted by pre-treatment TLS risk assessment and a creatinine clearance (CrCl) of < 80 mL/min [ 29 ]. The occurrence of TLS was dependent on tumor size, the presence of comorbidities (especially impaired renal function), and the venetoclax dose [ 33 ]. Obinutuzumab, when used as a pre-induction therapy in cycle 1 days 1 and 2, may reduce the risk of TLS if administered before venetoclax [ 19 , 37 , 38 ].…”

Section: Clinical Trials and Real-world Studies Of Venetoclax In Pati...mentioning

confidence: 99%

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Venetoclax Initiation in Chronic Lymphocytic Leukemia: International Insights and Innovative Approaches for Optimal Patient Care

Anderson,

Walewska,

Hackett

et al. 2024

Cancers

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Venetoclax, a highly selective, oral B-cell lymphoma 2 inhibitor, provides a robust targeted-therapy option for the treatment of chronic lymphocytic leukemia (CLL), including patients with high-risk del(17p)/mutated-TP53 and immunoglobulin heavy variable region unmutated CLL and those refractory to chemoimmunotherapy across all age groups. Due to the potent pro-apoptotic effect of venetoclax, treatment initiation carries a risk of tumor lysis syndrome (TLS). Prompt and appropriate management is needed to limit clinical TLS, which may entail serious adverse events and death. Venetoclax ramp-up involves gradual, stepwise increases in daily venetoclax dosing from 20 mg to 400 mg (target dose) over 5 weeks; adherence to on-label scheduling provides a tumor debulking phase, reducing the risk of TLS. The key components of safe venetoclax therapy involve assessment (radiographic evaluation and baseline blood chemistry), preparation (adequate hydration), and initiation (blood chemistry monitoring). In addition to summarizing the evidence for venetoclax’s efficacy and safety, this review uses hypothetical patient scenarios based on risk level for TLS (high, medium, low) to share the authors’ clinical experience with venetoclax initiation and present global approaches utilized in various treatment settings. These hypothetical scenarios highlight the importance of a multidisciplinary approach and shared decision-making, outlining best practices for venetoclax initiation and overall optimal treatment strategies in patients with CLL.

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Section: Clinical Trials and Real-world Studies Of Venetoclax In Pati...mentioning

confidence: 77%

Section: Clinical Trials and Real-world Studies Of Venetoclax In Pati...mentioning

confidence: 99%

Section: Clinical Trials and Real-world Studies Of Venetoclax In Pati...mentioning

confidence: 99%

See 1 more Smart Citation

Venetoclax Initiation in Chronic Lymphocytic Leukemia: International Insights and Innovative Approaches for Optimal Patient Care

Anderson,

Walewska,

Hackett

et al. 2024

Cancers

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“…First, we utilized real‐world data with control groups and propensity score matching to limit the impact of confounding in detected signals. Unlike traditional epidemiological studies or pharmacovigilance studies using the FDA Adverse Event Reporting System, 54–56 we evaluated all possible ADEs and not just predetermined or previously‐reported outcomes. Second, the large sample size provides sufficient power to detect rare ADEs.…”

Section: Discussionmentioning

confidence: 99%

Signal detection of adverse events associated with gabapentinoid use for chronic pain

Kuo,

Polychronopoulou,

Raji

2023

Pharmacoepidemiology and Drug

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IntroductionGabapentinoids (GABA) prescribing as a potential and conceivably safer substitute for opioids has substantially increased. Understanding all potential adverse drug events (ADEs) associated with GABA will guide clinical decision‐making for pain management.MethodsA 20% sample of Medicare enrollees with new chronic pain diagnoses in 2017–2018 was selected. GABA users were those with >=30 consecutive days prescription in a year without opioid prescription. Opioid users were similarly defined. The control group used neither of these drugs. Propensity score match across three groups based on demographics and comorbidity was performed. We used proportional reporting ratio (PRR), Gamma Poisson Shrinker, and tree‐based scan statistic (TBSS) to detect ADEs within 3, 6, and 12 months of follow‐up.ResultsImmunity disorder was detected within 3 months of follow‐up by PRR compared to opioid use (PRR:2.33), and by all three methods compared to controls. Complications of transplanted organs/tissues and schizophrenia spectrum/other psychotic disorders were consistently detected by PRR and TBSS within 3 months. Skin disorders were detected by TBSS; and stroke was detected by PRR within 3 months compared to opioid use (PRR:4.74). Some malignancies were detected by PRR within 12 months. Other signals detected in GABA users were neuropathy and nerve disorders.ConclusionsOur study identified expected and unexpected ADE signals in GABA users. Neurological signals likely related to indications for GABA use. Signals for immunity, mental/behavior, and skin disorders were found in the FDA adverse event reporting system database. Unexpected signals of stroke and cancer require further confirmatory analyses to verify.

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“…The database not only includes adverse event (AE) reports submitted to the FDA but also encompasses reports of medication errors and product quality complaints leading to AEs, typically reported by pharmacists, medical professionals, consumers, and others. The FAERS database comprises eight document types: Demographic and Administrative Information, Drug Information (DRUG), Indications for Use, Reporting Source, Start and End Dates of Reported Drugs, Patient Prognosis, as well as Invalidity Reporting, and Adverse Events ( Yang et al, 2022 ). Access to specific data is available on the FDA’s website: https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html .…”

Section: Methodsmentioning

confidence: 99%

Post-marketing safety evaluation of lurbinectedin: a pharmacovigilance analysis based on the FAERS database

Li,

Guo,

Liu

et al. 2024

Front. Pharmacol.

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Background: On 15 June 2020, the United States Food and Drug Administration (FDA) approved lurbinectedin for treating adult patients with metastatic small-cell lung cancer whose disease has progressed despite prior platinum-based chemotherapy. Following its market approval, safety data on lurbinectedin in large populations is currently lacking. Therefore, this study aims to evaluate adverse events (AEs) associated with lurbinectedin using the FDA’s Adverse Event Reporting System (FAERS)database.Methods: Data concerning lurbinectedin from the FAERS database were extracted for the period from June 2020 to September 2023. Four disproportionality analysis algorithms were utilized to assess potential AEs linked to lurbinectedin: reporting odds ratio (ROR), proportional reporting ratio, disproportionate multi-item gamma Poisson shrinker, and Bayesian confidence propagation neural network. These algorithms were applied to quantify signals of lurbinectedin-related AEs.Result: A total of 5,801,535 AE reports were retrieved from the FAERS database, with 511 related to lurbinectedin. These lurbinectedin-induced AEs were observed in 23 system organ classes (SOCs). After simultaneously applying the four algorithms, 47 lurbinectedin-induced AE signals were detected in 23 SOCs. At the SOC level, blood and lymphatic system disorders (ROR, 6.70; 95% confidence interval [CI]: 5.47–8.22) were the only SOC that met all four algorithms. Lurbinectedin’s most frequent adverse event was death (ROR: 6.11%, 95% CI: 4.86–7.68), while extravasation exhibited the strongest signal intensity in the ROR algorithm (ROR: 326.37%, 95% CI: 191.66–555.75). Notably, we identified a novel signals: tumor lysis syndrome (ROR: 63.22%, 95% CI: 33.87–117.99). The mean time of onset of AEs was 66 days, the median time of onset was 25 days (interquartile range: 8–64 days), and most AEs occurred within the first month of lurbinectedin treatment.Conclusion: Our study provided a comprehensive evaluation of lurbinectedin’s safety profile in the post-marketing setting. In addition to the adverse events consistent with the existing clinical trials and labeling information, we have also identified an unreported signal related to tumor lysis syndrome. This finding will better guide the clinical practice of lurbinectedin and provide valuable evidence for future research.

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A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for venetoclax

Cited by 7 publications

References 48 publications

Venetoclax Initiation in Chronic Lymphocytic Leukemia: International Insights and Innovative Approaches for Optimal Patient Care

Venetoclax Initiation in Chronic Lymphocytic Leukemia: International Insights and Innovative Approaches for Optimal Patient Care

Signal detection of adverse events associated with gabapentinoid use for chronic pain

Post-marketing safety evaluation of lurbinectedin: a pharmacovigilance analysis based on the FAERS database

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