Expert Opinion On Drug Safety[JOURNAL]
Sun
200 papers
Mining and analysis of amphotericin B adverse reaction signals: a real-world study based on the FAERS database.
Wang S, Cheng Y, Wang X … +1 more , Wang Q
Expert Opin Drug Saf · 2025 Mar · PMID 40070343 · Publisher ↗
BACKGROUND: Invasive fungal infections (IFIs) have become an increasingly serious public health problem. Amphotericin B (AmB) remains the important component in the treatment of IFIs. But its clinical application is limi...
BACKGROUND: Invasive fungal infections (IFIs) have become an increasingly serious public health problem. Amphotericin B (AmB) remains the important component in the treatment of IFIs. But its clinical application is limited due to its adverse reactions. RESEARCH DESIGN AND METHODS: In this study we mined the adverse drug event signals of AmB based on the Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter of 2004 to the third quarter of 2023, using the Reported Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network and Multi-item Gamma Poisson Shrinker methods to provide a reference for the safe clinical use. RESULTS: A total of 3597 adverse event (AE) reports for the primary suspect drug AmB were obtained, involving 22 system organ classes (SOCs), 1355 AEs. Patients aged 18-60 (47.93%) and female patients (53.82%) were at a higher risk of AEs with AmB. High risk signals in the report include hypokalemia, pyrexia, chill, renal failure. Additional high risk signals not mentioned in the instructions conclude respiratory failure, tachycardia, deafness. CONCLUSIONS: Mining the adverse reaction signal study of AmB based on the FAERS database provides support for the clinical monitoring and risk identification of this drug.
JAK inhibitors and pregnancy in autoimmune disease: safety insights from existing evidence.
Huang H, Wang Y, Han L … +2 more , Wu Y, Li C
Expert Opin Drug Saf · 2025 Sep · PMID 40059105 · Publisher ↗
Abstract loading — click title to view on PubMed.
Drug-associated pancreatic cancer: insights from real-world pharmacovigilance and network pharmacology.
Xie H, Xu Q, Zhao B … +1 more , Wu W
Expert Opin Drug Saf · 2025 Mar · PMID 40049721 · Publisher ↗
BACKGROUND: Pancreatic cancer's high mortality rate necessitates our study, which aims to identify potential risk drugs and speculate on the underlying mechanisms. RESEARCH DESIGN AND METHODS: All pertinent reports from...
BACKGROUND: Pancreatic cancer's high mortality rate necessitates our study, which aims to identify potential risk drugs and speculate on the underlying mechanisms. RESEARCH DESIGN AND METHODS: All pertinent reports from the FDA Adverse Event Reporting System database were extracted. The disproportionality analysis was used in signal detection and data on patient age, sex, weight, time to onset were collected. Seven databases were retrieved for network pharmacology. AutoDock Vina 1.1.2 was for molecular docking. RESULTS: Signals were detected among 397 drugs with pancreatic cancer report ≥3. Except 4 antineoplastic agents, only 24 drugs indicated pancreatic cancer signals in 33,948 reports including 4 dipeptidyl peptidase-4 (DPP-4) inhibitors, 3 glucagon-like peptide-1 (GLP-1) analogues, 5 compound hypoglycemic agents, 3 hypotensive agents, ranitidine, pancrelipase, fondaparinux, naldemedine, daprodustat, megestrol acetate, leuprorelin, lecanemab, and lorcaserin. Pancreatic cancer more occurred after the age of 45, with a higher proportion among male. Weight with GLP-1 analogues (median, 91 kg), and compound hypoglycemic agents (median, 82 kg) was heavier ( < 0.01). GLP1R (glucagon-like peptide 1 receptor) for GLP-1 analogues, and PTEN (phosphatase and tensin homolog) for metformin might be a potential cause of pancreatic cancer. CONCLUSION: Clinicians providing these therapies should stay vigilant to detect pancreatic cancer early.
Drug-induced hyperacusis: a disproportionality analysis of the FAERS database.
Lin H, Wang Q, Liu H … +1 more , Tang Y
Expert Opin Drug Saf · 2026 Jun · PMID 40047389 · Publisher ↗
BACKGROUND: Hyperacusis is a non-negligible clinical condition, but reports related to drug-induced hyperacusis are rare. The aim of this study was to investigate the risk of drug-induced hyperacusis and to identify the...
BACKGROUND: Hyperacusis is a non-negligible clinical condition, but reports related to drug-induced hyperacusis are rare. The aim of this study was to investigate the risk of drug-induced hyperacusis and to identify the top drugs that can cause hyperacusis through the FAERS database. RESEARCH DESIGN AND METHODS: We used the search term 'hyperacusis' to query all reports of hyperacusis in the FAERS database from 2004 (Q1) to 2023 (Q4), and extracted, cleaned, mined, and analyzed the data to retrieve the top medications that cause hyperacusis. RESULT: A total of 2937 unduplicated reports of hyperacusis were found, and the top 10 drugs among them were screened. 6 of them had positive results for all 4 calculations, which was regarded as a strong signal. The likelihood of drug-induced hyperacusis varied considerably between sexes, with females being approximately 2.5 times more likely than males to develop drug-induced hyperacusis. CONCLUSION: By analyzing the FAERS database, we listed drugs with strong hyperacusis that were not suggested on the label and analyzed that the cause of hyperacusis by these drugs is likely to be related to altered levels of 5-HT in the organism. Women are more likely than men to develop pharmacologic hyperacusis.
Post-marketing safety monitoring of tirzepatide: a pharmacovigilance study based on the FAERS database.
Chen H, Ding Y, Shan Y
Expert Opin Drug Saf · 2025 Aug · PMID 40037695 · Publisher ↗
OBJECTIVE: To explore adverse drug events (ADEs) associated with tirzepatide using real-world data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) database to guide its safe management...
OBJECTIVE: To explore adverse drug events (ADEs) associated with tirzepatide using real-world data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) database to guide its safe management. METHODS: ADE reports from the second quarter of 2022 to the fourth quarter of 2023 were analyzed using the Reporting Odds Ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) methods. Gender-specific differences and reporting biases were also assessed. RESULTS: Among 25,212 tirzepatide-related ADE reports, 101 significant ADE signals across 15 system organ classifications were identified. Common ADEs included nausea ( = 3030, ROR 5.38) and vomiting ( = 1147, ROR 3.44). Previously unreported ADEs included eructation ( = 500, ROR 46.56), gastroesophageal reflux disease ( = 191, ROR 3.24), injection site hemorrhage ( = 1610, ROR 27.8), and increased blood glucose ( = 641, ROR 6.22). Women reported more injection-site reactions, while men experienced more gastrointestinal issues. Weibull analysis indicated a median ADE onset time of 23 days (IQR: 6-90 days). CONCLUSION: This pharmacovigilance study identified both known and novel ADEs of tirzepatide, highlighting gender differences and reporting biases. Close monitoring and further research are needed to ensure its safe use.
Influence of rapidly increased numbers of reports on adverse events of the COVID-19 vaccine in the Japanese pharmacovigilance database on disproportionality analysis of antineoplastic drug-associated adverse cardiovascular events.
Matsuo H, Tanaka H, Endo K … +1 more , Ishii T
Expert Opin Drug Saf · 2026 Apr · PMID 40035831 · Publisher ↗
BACKGROUND: Antineoplastic drug-associated adverse cardiovascular events (ACEs) are a concern; however, information on new antineoplastic drugs is limited. In this situation, signal detection and hypothesis building by a...
BACKGROUND: Antineoplastic drug-associated adverse cardiovascular events (ACEs) are a concern; however, information on new antineoplastic drugs is limited. In this situation, signal detection and hypothesis building by analyzing the pharmacovigilance database are useful. However, increased numbers of reports on COVID-19 vaccine-related ACEs in the pharmacovigilance database have affected the results of the disproportionality analysis. Therefore, examining the effect of increased reports on COVID-19 vaccine-related ACEs on detecting anticancer drug-related ACEs is critical. RESEARCH DESIGN AND METHODS: Disproportionality analysis was performed using the Japanese Adverse Drug Event Report (JADER) database. Reporting odds ratio and information components were used as indicators to detect potential associations between drugs and adverse events. The analysis was performed in two situations: using all data in the JADER database and excluding cases with the COVID-19 vaccine. RESULTS: Various antineoplastic drugs were associated with diverse ACEs. Additionally, safety signals for ACEs of some antineoplastic drugs were masked by reports on COVID-19 vaccine-related ACEs. CONCLUSIONS: The rapid increased reports on COVID-19 vaccine-related ACEs in the JADER database had an impact on signal detection activities for antineoplastic drug-associated ACEs. Therefore, the impact of reporting COVID-19 vaccine-related ACEs on current signal detection activities should be evaluated over time.
The role of artificial intelligence in pharmacovigilance for rare diseases.
Jain A, Adenwala Z
Expert Opin Drug Saf · 2025 Aug · PMID 40022540 · Publisher ↗
INTRODUCTION: There are considerable gaps in the conventional pharmacovigilance (PV) measures which might result in significant safety issues, especially in monitoring the effectiveness of orphan drugs that are used to t...
INTRODUCTION: There are considerable gaps in the conventional pharmacovigilance (PV) measures which might result in significant safety issues, especially in monitoring the effectiveness of orphan drugs that are used to treat rare diseases. In this paper, we evaluate if and how Artificial Intelligence (AI) and Machine Learning (ML) can be used to mitigate these problems. AREAS COVERED: The article identifies ineffective adverse events (AE) reporting systems, low patient enrollment, and weak signal monitoring as barriers to the effective safety evaluation of rare diseases. It also addresses the possibility of employing AI and ML technologies to automate the reporting of AEs by integrating data from multiple sources and increasing the sensitivity of risk detection. The method to conduct the literature search consisted of searching PubMed and Google Scholar for relevant AI and ML studies and publications about PV. EXPERT OPINION: We identified technical and regulatory concerns such as privacy and model explainability as hurdles to the adoption of AI in PV. However, the same technology, if properly integrated into the system, has the potential to enhance treatment monitoring for rare diseases and to increase the rate of new therapies being developed.
Safety assessment of esomeprazole: real-world adverse event signal mining and analysis based on FAERS database.
Wang B, Huang S, Li S … +7 more , Deng Y, Li Z, Wang Y, Shi X, Zhang W, Shi L, Tang X
Expert Opin Drug Saf · 2026 Jul · PMID 40019211 · Publisher ↗
BACKGROUND: Esomeprazole holds a significant position in the treatment of acid-related diseases. However, as with all drugs, it may also carry some potential risk of adverse effects. This study aims to further evaluate t...
BACKGROUND: Esomeprazole holds a significant position in the treatment of acid-related diseases. However, as with all drugs, it may also carry some potential risk of adverse effects. This study aims to further evaluate the safety of esomeprazole for clinical use. RESEARCH DESIGN AND METHODS: The data of esomeprazole-related adverse events was extracted from the FAERS database from the first quarter of 2004 to the first quarter of 2024 and used Reporting Odds Ratios (ROR), Proportional Reporting Ratios (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean(EBGM) for data mining. RESULTS: A total of 67,712 esomeprazole-related adverse events were extracted from the FAERS database, involving 27 system organ class. The frequency of renal and urinary occurrence was the highest, and the signal was the strongest. Additionally, we detected 324 preferred terms: rebound acid hypersecretion, nephrogenic anemia, and hyperparathyroidism secondary showed significant high signal strength. In the elderly, adverse events were concentrated in the gastrointestinal disorders system, and the most common adverse events were dyspepsia and hyponatremia. Unexpected adverse events, such as vomiting, acute kidney injury, and anaphylactic reaction occurred in children. CONCLUSIONS: We discovered some new and special esomeprazole-related adverse events, raising awareness of the safety of esomeprazole and further helping to mitigate associated risks.
Post-marketing safety of Adagrasib: a disproportionality analysis based on the FAERS database.
Shi Z, Yu X, Zhao Y … +3 more , Shao K, Xu C, Song Z
Expert Opin Drug Saf · 2026 Jul · PMID 40011229 · Publisher ↗
BACKGROUND: Adagrasib is a novel KRAS G12C inhibitor. While its clinical efficacy has been demonstrated, comprehensive post-marketing safety data remain limited. This study aimed to analyze adverse reactions involving Ad...
BACKGROUND: Adagrasib is a novel KRAS G12C inhibitor. While its clinical efficacy has been demonstrated, comprehensive post-marketing safety data remain limited. This study aimed to analyze adverse reactions involving Adagrasib from the FAERS database to identify potential safety signals. RESEARCH DESIGN AND METHODS: A retrospective pharmacovigilance analysis was performed using FAERS data during Q4 2022 through Q2 2024. After deduplication. disproportionality analysis was performed using four algorithms: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM). RESULTS: A total of 598 cases involving Adagrasib were identified, encompassing 1717 adverse events (AEs). The most common AEs were diarrhea, nausea, vomiting, asthenia, and decreased appetite. New strong significant AE signals were detected, including dissociation, status epilepticus, cerebral disorder, and photosensitivity reaction. The median time to AE onset was 34 days, and most AEs happened within the initial month of treatment. CONCLUSIONS: Our study highlights some new AE signals associated with Adagrasib, emphasizing the importance of continued pharmacovigilance. While the findings contribute to understanding Adagrasib's safety profile, further validation through large-scale prospective studies is needed.
Effects of nirmatrelvir/ritonavir (Paxlovid) on the nervous system: analysis on adverse events released by FDA.
Gao C, Liu Z, Zou Z … +2 more , Mao L, Zhang J
Expert Opin Drug Saf · 2026 Apr · PMID 40011202 · Publisher ↗
BACKGROUND: Nirmatrelvir/ritonavir, commonly known as Paxlovid, is one of the main drugs used to treat COVID-19. Neurological disorders are among the adverse drug reactions (ADRs) linked to Paxlovid, yet comprehensive da...
BACKGROUND: Nirmatrelvir/ritonavir, commonly known as Paxlovid, is one of the main drugs used to treat COVID-19. Neurological disorders are among the adverse drug reactions (ADRs) linked to Paxlovid, yet comprehensive data-mining studies based on real-world neurological adverse events induced by Paxlovid are lacking. METHODS: It is an observational study, to reduce the risk of bias affected by COVID-19 disease, our study included only patients with COVID-19 disease. In this case, disproportionate analysis is performed using the Report Odds Ratio (ROR) and its 95% Confidence Interval (CI). RESULTS: We screened and compared all medications associated with COVID-19 ( = 439) and found that 22 of these were linked to neurological adverse reactions. Paxlovid was associated with a threefold greater number of neurological adverse events compared to all other drugs combined ( = 11,792), with a strong signal value (ROR = 2.27). CONCLUSIONS: Compared to all other COVID-19-related drugs, Paxlovid has the highest number and stronger signal value for neurologic-related adverse reactions. Clinicians should pay special attention to female patients taking Paxlovid within the first 30 days, monitoring for symptoms such as dysgeusia, ageusia, headache, and anosmia. In addition, headache and anosmia are not uncommon occurrences as mentioned in the instructions and should be noted.
Incidence and risk of drug-induced interstitial lung disease associated with anti-neoplastic drugs.
Hwang IH, Lee SH, Lee H
Expert Opin Drug Saf · 2025 Aug · PMID 40007198 · Publisher ↗
BACKGROUND: To evaluate the incidence and risk of drug-induced interstitial lung disease (DIILD) associated with anti-neoplastic drugs among patients with cancer in Korea. RESEARCH DESIGN AND METHODS: This nested case-co...
BACKGROUND: To evaluate the incidence and risk of drug-induced interstitial lung disease (DIILD) associated with anti-neoplastic drugs among patients with cancer in Korea. RESEARCH DESIGN AND METHODS: This nested case-control study included 457,685 patients diagnosed with cancer and treated with anti-neoplastic drugs from a retrospective nationwide population-based cohort between 2017 and 2021. The incidence rate of DIILD and the risks of DIILD by anti-neoplastic drug categories were analyzed. RESULTS: Among 270,595 patients, 2,634 developed ILD, resulting in an incidence rate of 4.12 per 1,000 person-years (95% confidence interval (CI): 3.97-4.28). DIILD was more prevalent in men, older patients, and those with a history of pulmonary disease or lung cancer. In a multivariable conditional logistic regression analysis, immune checkpoint inhibitors (odds ratio (OR): 2.37; 95%CI: 1.48-3.78), mammalian target of rapamycin inhibitors (OR: 9.79; 95%CI: 5.20-18.45), antibody-drug conjugates (OR: 7.99; 95%CI: 3.24-19.74), cyclin-dependent kinase 4/6 inhibitors (OR: 2.28; 95%CI: 1.26-4.12), and any combination of different drug categories (OR: 1.93; 95%CI: 1.21-3.09) were associated with an increased risk of DIILD. CONCLUSION: Our findings suggest that the risk of incident DIILD depends on the category of anti-neoplastic drugs. Patients with identified risk factors and treated with these drugs should be monitored closely.
Post-marketing safety surveillance of Amivantamab: a real world study based on the FDA adverse event reporting system.
Fu X, Zeng D, Li M … +10 more , Wu J, Yang Y, Mao Q, Qiu W, Huang X, Fang Y, Jiang L, Hu P, Wu J, Liao W
Expert Opin Drug Saf · 2026 Jul · PMID 40001304 · Publisher ↗
BACKGROUND: Amivantamab stands as the pioneering bispecific antibody that targets both EGFR and MET, utilized in the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR ex20ins m...
BACKGROUND: Amivantamab stands as the pioneering bispecific antibody that targets both EGFR and MET, utilized in the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR ex20ins mutations. Nevertheless, a thorough assessment of its safety characteristics in the real-world remains unknown. RESEARCH DESIGN AND METHODS: The adverse event (AE) reports were collected through a search of the FDA Adverse Event Reporting System (FAERS) database spanning from 2019 Q1 to 2024 Q1, and then disproportionality analysis was utilized. RESULTS: Totally, 9,252,269 AE reports were obtained from the FAERS database, with 893 reports of amivantamab classified as primary suspect AEs. Amivantamab-related AEs were distributed in 23 organ systems, and 87 significant preferred terms (PTs) met the reporting odds ratio criteria. Novel significant AEs were detected, and the median time to onset of amivantamab-associated AEs was 43 days. In subgroup analysis, a higher proportion of patients who were male, over 65 years, and with pneumonitis or pneumonia were reported in the death cases. We also found that AEs may vary between intravenous and subcutaneous administration. CONCLUSIONS: This investigation offered novel prospects for monitoring and addressing undesirable medication effects associated with amivantamab, which might improve the clinical medication safety.
Update of safety profile of levonorgestrel: a disproportionality analysis based on FAERS from 2004 to 2023.
Lai W, Liang J, Xiang Y … +7 more , Hu Q, Huang J, Chen M, Chen X, Sun B, Yang Q, Deng K
Expert Opin Drug Saf · 2025 Mar · PMID 39995329 · Publisher ↗
BACKGROUND: Levonorgestrel has been utilized in emergency contraception (EC) and for endometrial conditions. While abnormal uterine bleeding is a recognized adverse event (AE), other potential AEs remain undocumented. RE...
BACKGROUND: Levonorgestrel has been utilized in emergency contraception (EC) and for endometrial conditions. While abnormal uterine bleeding is a recognized adverse event (AE), other potential AEs remain undocumented. RESEARCH DESIGN AND METHODS: Safety data for levonorgestrel were acquired from the United States FDA Adverse Event Reporting System (FAERS) database, covering the period from the first quarter (Q1) of 2004 to the fourth quarter (Q4) of 2023. A disproportionality analysis was conducted to assess the association between levonorgestrel and AEs. RESULTS: A total of 136,168 AEs associated with levonorgestrel were reported. 106 preferred terms (PTs) and 2 system organ class (SOCs) met the criteria established by four algorithms. The identified PTs were vaginal hemorrhage, irregular menstruation, genital hemorrhage and so on. The SOCs encompassed reproductive system and breast disorders, as well as pregnancy, puerperium, and perinatal conditions. CONCLUSIONS: Although most findings align with the existing drug inserts for levonorgestrel, several novel AEs were identified in our study. Therefore, ongoing monitoring of this drug is essential and its safety profile should be updated regularly to enhance clinical practice regulation.
Assessing adverse event burden in chronic lymphocytic leukemia treatment regimens: what's best for patient quality of life?
Korycka-Wołowiec A, Wołowiec D, Ławnicka H … +1 more , Robak T
Expert Opin Drug Saf · 2025 Jun · PMID 39991898 · Publisher ↗
INTRODUCTION: In recent years, chronic lymphocytic leukemia (CLL) treatment has changed dramatically. Chemoimmunotherapy with fludarabine/cladribine, cyclophosphamide, and rituximab have been almost completely replaced b...
INTRODUCTION: In recent years, chronic lymphocytic leukemia (CLL) treatment has changed dramatically. Chemoimmunotherapy with fludarabine/cladribine, cyclophosphamide, and rituximab have been almost completely replaced by targeted therapies with small molecules, such as Bruton's tyrosine kinase inhibitors or B-cell lymphoma 2 (BCL-2) antagonists. However, few studies have assessed the impact of novel therapies on patient quality of life (QoL). AREAS COVERED: This article reviews the safety profile of new therapeutic options and their impact on the QoL of CLL patients. The MEDLINE database was searched for English language publications from 2010 through June 2024, including the Proceedings of the American Society of Hematology from over the past 5 years. EXPERT OPINION: CLL is a clinically heterogenous disease predominantly affecting elderly patients. The variable clinical course of disease requires personalization and individualized treatment to achieve the optimal survival outcome and acceptable safety profile, especially in the case of poor prognosis. Clinical trials performed in the past decade indicate that novel drugs, used as a single agent or as part of a conventional chemotherapy, offer promise in minimalizing relapse rates, and may allow more effective and safer treatment options by reducing the risk of adverse events, especially cytopenias and infections.
Review of studies evaluating the effectiveness of risk minimization measures for oncology medicinal products registered in the European Medicines Agency (HMA-EMA) catalogue: findings and lessons learned.
Monteiro J, Almeida D, Fernandes JP … +2 more , Sepodes B, Torre C
Expert Opin Drug Saf · 2026 Jun · PMID 39989100 · Publisher ↗
BACKGROUND: Risk management in oncology is critical due to toxicity, narrow therapeutic windows, and strict dosing schedules. This study analyzed post-authorization studies from the HMA-EMA Real-World Data Catalogues eva...
BACKGROUND: Risk management in oncology is critical due to toxicity, narrow therapeutic windows, and strict dosing schedules. This study analyzed post-authorization studies from the HMA-EMA Real-World Data Catalogues evaluating the effectiveness of risk minimization measures (RMM) for oncology medicines. RESEARCH DESIGN AND METHODS: We reviewed all RMM effectiveness studies registered in the HMA-EMA RWD Catalogues until February 2024, focusing on medicines classified under ATC codes 'L' and 'V10' for oncological conditions. Data from protocols and reports were analyzed, including study design, population, objectives, RMM types, process and outcomes indicators and reported effectiveness. RESULTS: Out of 1,280 records, 21 studies met the inclusion criteria. Most studies (81%) were cross-sectional surveys, 57% targeted healthcare professionals, and 86% used primary data. Additional RMMs were evaluated in 81% of studies. Process indicators were assessed in nearly all studies, but only 5% included outcome indicators. Of the 15 studies with available results, 60% were deemed effective, 27% inconclusive, and 13% ineffective by the sponsors. CONCLUSIONS: Future studies should set success thresholds in advance, use a dual evidence approach to measure outcomes, and consider new methods to increase participant numbers. Feasibility assessments prior to conducting studies are essential for achieving meaningful objectives in oncology risk management.
Risk of acute renal failure associated with combined use of SGLT2 inhibitors and potentially nephrotoxic drugs: an epidemiological surveillance study based on the FDA adverse event reporting system (FAERS).
Yu T, Xiao J, Li M … +7 more , Cheng SQ, Cai R, Huang L, Yu H, Li JY, Zhang YY, Wang Y
Expert Opin Drug Saf · 2025 Mar · PMID 39985753 · Publisher ↗
BACKGROUND: Limited knowledge exists regarding nephrotoxic risks associated with the combination of sodium-glucose co-transporter-2 inhibitors (SGLT2i) and potentially nephrotoxic drugs. This study evaluates acute renal...
BACKGROUND: Limited knowledge exists regarding nephrotoxic risks associated with the combination of sodium-glucose co-transporter-2 inhibitors (SGLT2i) and potentially nephrotoxic drugs. This study evaluates acute renal failure (ARF) events linked to such combinations using data from the FDA Adverse Event Reporting System (FAERS). METHODS: Signal mining was performed by estimating reporting odds ratios (ROR), with validation through additive, multiplicative, and proportional reporting ratio (PRR) models. Logistic regression assessed mortality risk factors. RESULTS: Among 4,417,195 reports, 1,636 ARF cases were associated with SGLT2i combinations, primarily involving diuretics, lipid-lowering agents, and anticoagulants. The highest ARF risk was observed with dapagliflozin-cefazolin [ROR adjusted (a) 59.63, 95% CI (9.96, 356.87); ROR adjusted (b) 19.88, 95% CI (1.80, 219.21); additive model (0.53); multiplicative model (8.36); PRR (8.53)]. Consistent associations were found for empagliflozin-allopurinol and canagliflozin-vancomycin. Among single drugs, 12, including canagliflozin, met all four significance criteria for ARF signals. Logistic regression revealed male patients had higher mortality risk (OR = 0.356, = 0.043). CONCLUSION: This study confirms prior evidence of ARF associated with the combined use of SGLT2i with diuretics or NSAIDs and identifies new risks with proton pump inhibitors (PPIs), antigout medications, and anticoagulants. Male gender was a significant risk factor.
A comprehensive exploration of adverse reactions to lapatinib: a disproportionate analysis based on the FAERS database.
Zhou Y, Gong J, Deng X … +6 more , Shen L, Ge A, Fan H, Ling J, Wu S, Liu L
Expert Opin Drug Saf · 2025 Dec · PMID 39985750 · Publisher ↗
BACKGROUND: Lapatinib, an FDA-approved tyrosine kinase inhibitor, treats HER2+ advanced/metastatic breast cancer. This study comprehensively analyzed its adverse reaction profile using FDA Adverse Event Reporting System...
BACKGROUND: Lapatinib, an FDA-approved tyrosine kinase inhibitor, treats HER2+ advanced/metastatic breast cancer. This study comprehensively analyzed its adverse reaction profile using FDA Adverse Event Reporting System (FAERS) to guide clinical use. RESEARCH DESIGN AND METHODS: Adverse event (AE) reports for lapatinib from the second quarter of 2007 to the second quarter of 2024 in FAERS were analyzed using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Multi-item Gamma Poisson Shrinkage (MGPS) and Bayesian Confidence Propagation Neural Network (BCPNN) to identify AE signals. RESULTS: Among 8300 AE reports, females (91.47%) and ages 40-59.9 (33.71%) were predominant. 20 system organ classifications (SOCs) were affected, with gastrointestinal disorders (ROR = 3.46) and skin disorders (ROR = 2.47) most significant. Based on the PT level, a total of 111 PTs were analyzed that met the four algorithms, including typical AEs such as diarrhea ( = 3410), vomiting ( = 856), and rash ( = 856), as well as some rare AEs that were not prompted by the drug inserts, such as neutropenia ( = 252), pericardial effusion ( = 43), lymphedema ( = 20). The majority of lapatinib-associated AEs had onset within 30 days (51%). CONCLUSIONS: Lapatinib has a generally favorable safety profile, but gastrointestinal toxicity and dermatotoxicity require close monitoring to prevent serious AEs.
Safety evaluation of ILaris: a real-world analysis of adverse events based on the FAERS database.
Yi X, Wu S, He H … +1 more , Li Y
Expert Opin Drug Saf · 2025 Mar · PMID 39985474 · Publisher ↗
BACKGROUND: There is a lack of real-world studies on the safety of Ilaris in large populations. The purpose of this study was to investigate adverse events (AEs) associated with Ilaris using data from the FDA Adverse Eve...
BACKGROUND: There is a lack of real-world studies on the safety of Ilaris in large populations. The purpose of this study was to investigate adverse events (AEs) associated with Ilaris using data from the FDA Adverse Event Reporting System (FAERS) database to guide clinical use. METHODS: We evaluated retrospectively extracted reports of AEs from the FAERS database between the first quarter of 2009 and the second quarter of 2024. The presence of a significant association between Ilaris and AEs was assessed by using disproportionality analyses including ROR,PRR,BCPNN,MGPS. RESULTS: After evaluating 14,691,170 data, 7968 ILaris-associated AEs were obtained after removing duplicates and unspecified sex items. A number of AEs were finalized through the study, including Common Pyrexia, Condition Aggravated, Influenza, and unexpected signals not listed in the drug insert, such as Pulmonary Thrombosis, Hepatomegaly, Blood Lactate Dehydrogenase Increased, Splenomegaly, Appendicitis. Ilaris induced AEs involving 27 system organ classes (SOCs). There were gender differences in AEs signaling associated with Ilaris. CONCLUSIONS: It is critical for healthcare professionals to closely monitor patients for symptoms (such as pulmonary thrombosis, Hepatomegaly, Blood Lactate Dehydrogenase Increased, Splenomegaly, Appendicitis) and other adverse events during treatment.
Safety of dual orexin receptor antagonists: a real-world pharmacovigilance study.
Sun Y, Xu T, Xu H
Expert Opin Drug Saf · 2025 Feb · PMID 39985333 · Publisher ↗
BACKGROUND: Dual orexin receptor antagonists (DORAs) are widely used for treating insomnia. However, real-world data on the adverse events (AEs) induced by DORAs are lacking. METHODS: Data related to daridorexant, suvore...
BACKGROUND: Dual orexin receptor antagonists (DORAs) are widely used for treating insomnia. However, real-world data on the adverse events (AEs) induced by DORAs are lacking. METHODS: Data related to daridorexant, suvorexant, and lemborexant were collected from the US Food and Drug Administration Adverse Event Reporting System between the first quarter of 2022 and the third quarter of 2024. Two established signal quantification methods, the reporting odds ratios and proportional reporting ratios, were applied. RESULTS: A total of 2665 reports on daridorexant (1738, 65.22%), suvorexant (667, 25.03%), and lemborexant (260, 9.75%) were obtained. 24 targeted systems for daridorexant, 24 for suvorexant, and 25 for lemborexant were involved. We analyzed the top 30 preferred terms (PTs) that met both algorithm criteria and identified 69 PTs. The highest signal of strength of PT was sleep paralysis for daridorexant and lemborexant, and abnormal sleep-related event for suvorexant. The most frequent PT was somnolence for lemborexant (30, 11.54%) and insomnia for daridorexant (252, 14.50%) and suvorexant (62, 9.30%) within the top 30 PTs. CONCLUSION: The analysis of disproportionality signals may prompt increased awareness of toxicities for DORAs. The results of serious reports and dosage of drugs provided supporting evidence for clinicians to manage AEs.
Comprehensive analysis of adverse events associated with T-cell engagers using the FAERS database.
Le X, Zhang Y, Ma J
Expert Opin Drug Saf · 2025 Jul · PMID 39982395 · Publisher ↗
BACKGROUND: T-cell engagers (TCEs) are transformative immunotherapies with significant potential in treating hematologic malignancies and solid tumors. However, their real-world safety profiles remain inadequately charac...
BACKGROUND: T-cell engagers (TCEs) are transformative immunotherapies with significant potential in treating hematologic malignancies and solid tumors. However, their real-world safety profiles remain inadequately characterized. RESEARCH DESIGN AND METHODS: Using the FDA Adverse Event Reporting System (FAERS) database (October 2019 - September 2024, 8,747,158 reports), we analyzed adverse events (AEs) associated with nine TCEs. Disproportionality analysis identified overreported AEs, with 11,963 unique reports analyzed after deduplication. RESULTS: Blinatumomab was the most reported TCE ( = 4,950), and Tarlatamab the least ( = 185). Predominant AEs included immune system disorders, particularly cytokine release syndrome (IC range: 6.08-7.47). Drug-specific signals included reproductive system and breast disorders (IC: 2.74) and vascular disorders (IC: 2.25) with Tebentafusp, renal and urinary disorders with Epcoritamab (IC: 1.84), and eye disorders with Elranatamab (IC: 1.81). Novel AEs were also uncovered, including second malignant neoplasms, vasogenic cerebral edema with Mosunetuzumab (IC: 5.77, ROR: 56.29), and hydronephrosis with Epcoritamab (IC: 7.50, ROR: 180.70). Early-onset events (0.5-9.5 days) were linked to four TCEs, while delayed-onset events (>20 days) were linked to five others. CONCLUSIONS: This study highlights diverse AE profiles of TCEs, providing insights for clinicians to optimize their safe use in practice.
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