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Objective: The FDA Adverse Event Reporting System (FAERS) was used to mine and evaluate adverse events (AEs) associated with cyclin-dependent kinase (CDK) 4/6 inhibitors, thereby providing a reference for clinical rational drug use. Methods: AE data related to CDK4/6 inhibitors from the first quarter of 2015 to the first quarter of 2023 were acquired from FAERS, while the signal mining was processed using the reporting odds ratio (ROR) method and Bayesian confidence propagation neural network (BCPNN) method. Results: The number of AE reports for CDK4/6 inhibitors was, respectively, 132,494 for palbociclib, 56,151 for ribociclib, and 7,014 for abemaciclib. The corresponding numbers of AE signals were 322,522, and 59, with the number of involved System Organ Class (SOC) being 23, 23, and 15, mainly involving blood and lymphatic system disorders, respiratory, thoracic and mediastinal disorders, hepatobiliary disorders, skin and subcutaneous tissue disorders, etc. Conclusion: CDK4/6 inhibitors could lead to pulmonary toxicity, myelosuppression, skin reactions, etc. Special attention should be paid to abemaciclib for interstitial lung disease (ILD), erythema multiforme, and thrombosis risk; ribociclib for cardiac toxicity, hepatotoxicity, and musculoskeletal toxicity; palbociclib for neurocognitive impairment and osteonecrosis of the jaw. [ABSTRACT FROM AUTHOR]

Background: This study aims to analyze adverse events (AEs) associated with naltrexone based on the FAERS database, providing a foundation for its safety monitoring., Research Design and Methods: Disproportionality analysis methods, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS) algorithms, were employed to quantify signals of naltrexone-related AEs ., Results: AEs related to naltrexone from the first quarter of 2013 to the fourth quarter of 2023 were extracted from the FAERS database for detailed analysis. Among a total of 41,757,311 reports 28,745 were directly associated with naltrexone, involving 27 organ systems. We identified 110 positive signals for AEs at the preferred term (PT) level using disproportionality analysis, which included known AEs such as agitation, depressed mood, sleep disorder, tremor, delirium, and decreased libido. Additionally, our findings suggested potential risks of restless legs syndrome, eosinophilic pneumonia, and otolithiasis, which were not mentioned in the drug's label, thereby supplementing the existing safety information., Conclusions: The analysis of the FAERS database identified AEs associated with naltrexone, contributing to the awareness of clinical practitioners and pharmacists regarding the drug-related risk signals. This awareness facilitates timely preventive and therapeutic measures, ensuring patient safety.

Background: Amivantamab has been approved for EGFR exon 20 insertion-mutated non-small-cell lung cancer. The aim of this study was to perform an in-depth analysis of its safety profile., Research Design and Methods: Safety reports were collected from the database of the Food and Drug Administration Adverse Event Reporting System from April 2021 to September 2023, and the reporting odds ratio (ROR) method was used to detect potential safety signals. Mobocertinib, an agent with similar properties to amivantamab, served as a control for comparison., Results: A total of 88 safety signals were detected, most of which were novel. In comparison with mobocertinib, amivantamab appeared to cause more injury, poisoning, and procedural complications (ROR = 15.54, 95% CI 10.25-23.58); respiratory, thoracic, and mediastinal disorders (ROR = 1.92, 95% CI 1.57-2.34); infections and infestations (ROR = 1.39, 95% CI 1.09-1.76); blood and lymphatic system disorders (ROR = 9.57, 95% CI 6.17-14.84); and immune system disorders (ROR = 6.41, 95% CI 3.14-13.12). Moreover, amivantamab was associated with higher risks of thrombosis events, bone marrow suppression, skin and soft tissue infection, deterioration of respiratory symptoms, and noninfectious pneumonitis., Conclusion: The safety profile of amivantamab requires attention; particularly, monitoring of the adverse drug events described above is necessary during its administration.

Background: Aducanumab, a monoclonal antibody, received approval for the treatment of Alzheimer's disease in 2021. However, it remains controversial over the security of this drug. In this study, aducanumab-related adverse events (AEs) were evaluated through data mining based on the FDA Adverse Event Reporting System (FAERS) database., Research Design and Methods: The AE reports induced by aducanumab as the primary suspected drug were extracted from the FAERS database. The clinical characteristics of aducanumab-associated reports were analyzed. The potential new AE signals of aducanumab were explored using four disproportionality analysis methods. Furthermore, the difference in aducanumab-associated AE signals was investigated concerning sex, age, weight, dose, onset time, and continent., Results: In total, 328 reports and 793 AEs associated with aducanumab were identified. Six new AEs were identified. No significant sex and weight difference in aducanumab-related signals was found. Notably, nervous system disorders, especially 'amyloid related imaging abnormality-edema/effusion' and 'amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits,' were more frequently to be reported within 121-240 days, particularly in Europe., Conclusions: This study contributes real-world evidence regarding the safety of aducanumab.