Expert Opinion On Drug Safety[JOURNAL]
Sun
200 papers
Analysis of adverse events induced by fluconazole based on FAERS database.
Su T, Jianglin L, Si S … +1 more , Xin L
Expert Opin Drug Saf · 2025 Apr · PMID 40202020 · Publisher ↗
BACKGROUND: Fluconazole, a widely used antifungal agent, has been associated with various adverse events (AEs). This study aimed to analyze the safety profiles of fluconazole using the FDA Adverse Event Reporting System...
BACKGROUND: Fluconazole, a widely used antifungal agent, has been associated with various adverse events (AEs). This study aimed to analyze the safety profiles of fluconazole using the FDA Adverse Event Reporting System (FAERS) database to provide insights for its safe use. RESEARCH DESIGN AND METHODS: Fluconazole-related AEs from 2004 to 2024Q2 were extracted from the FAERS database. The Reporting Odds Ratio (ROR) method was employed to detect and analyze safety signals. Additionally, the impact of COVID-19 on fluconazole safety was also examined. RESULTS: A total of 7,720 AEs were identified, with 40.3% being serious. The most common AEs involved skin, gastrointestinal, and administration site reactions. High doses of fluconazole were linked to increased teratogenic risks. Weekly dosing regimens and doses below 200 mg/day were associated with fewer severe AEs. During the COVID-19 pandemic, there was a notable rise in reports of drug inefficacy and hepatic/renal damage. Additionally, 45 new adverse reactions were identified. CONCLUSIONS: The study highlights the importance of monitoring liver, kidney, and cardiovascular functions during fluconazole use, especially in high-risk populations. The findings underscore the need for careful dosing and consideration of drug interactions, particularly during the COVID-19 pandemic, to ensure safe and effective use of fluconazole.
Diarrhea-predominant irritable bowel syndrome treatment options eluxadoline, rifaximin, and alosetron: analysis of the FDA adverse event reporting system (FAERS) database.
Andrews MB, Adler DG
Expert Opin Drug Saf · 2025 Apr · PMID 40197054 · Publisher ↗
BACKGROUND: Adverse events (AEs) suspected to be associated with the three FDA approved medications (eluxadoline, rifaximin, and alosetron) for diarrhea-predominant irritable bowel syndrome (IBS-D) were examined. RESEARC...
BACKGROUND: Adverse events (AEs) suspected to be associated with the three FDA approved medications (eluxadoline, rifaximin, and alosetron) for diarrhea-predominant irritable bowel syndrome (IBS-D) were examined. RESEARCH DESIGN AND METHODS: We analyzed all reports in the FDA Adverse Event Reporting System (FAERS) database from each medication's date of FDA approval through 30 June 2024. Reports were excluded if they contained other suspected medications or had a reason for use outside of IBS and/or diarrhea. RESULTS: Eluxadoline was associated with 1,002 AEs, most commonly abdominal pain ( = 257, 17.0%) and uniquely pancreatitis ( = 174, 11.5%) and sphincter of Oddi dysfunction ( = 39, 2.6%). Rifaximin was associated with 652 AEs, most commonly abdominal pain ( = 64, 7.6%) and uniquely and bacterial overgrowth ( = 3, 0.4% each). Alosetron was associated with 3,832AEs, most commonly constipation ( = 2,007, 23.1%) and uniquely colitis ( = 235,2.7%), ischemic colitis ( = 140, 1.6%), obstruction ( = 110, 1.3%), and perforation ( = 26, 0.3%). CONCLUSIONS: Our analysis of the FAERS database showed frequent reports of abdominal pain, constipation, and nausea/vomiting related to the three FDA approved medications for IBS-D. Each raised concerns for distinct and serious AEs including pancreatitis (eluxadoline), infection (rifaximin), ischemic colitis (alosetron), and intestinal obstruction/perforation (alosetron).
The adverse reactions of bevacizumab in combination with the FOLFOX chemotherapy regimen in metastatic colorectal cancer.
Luo D, Zheng J, Liu B … +5 more , Zheng B, Jiang J, Huang S, Zhong Z, Zeng W
Expert Opin Drug Saf · 2025 May · PMID 40195595 · Publisher ↗
BACKGROUND: Bevacizumab combined with FOLFOX improves outcomes in metastatic colorectal cancer (mCRC), but comprehensive safety evaluations remain limited. RESEARCH DESIGN AND METHODS: We analyzed adverse drug reactions...
BACKGROUND: Bevacizumab combined with FOLFOX improves outcomes in metastatic colorectal cancer (mCRC), but comprehensive safety evaluations remain limited. RESEARCH DESIGN AND METHODS: We analyzed adverse drug reactions (ADRs) in the FDA Adverse Event Reporting System (FAERS), comparing FOLFOX monotherapy (366 reports), combination therapy (517 reports), and bevacizumab monotherapy (1,604 reports). Disproportionality analysis using ROR, PRR, BCPNN, and EBGM identified significant ADRs. RESULTS: Twenty-one ADRs were significantly associated with FOLFOX-bevacizumab combination therapy, predominantly infections (e.g. febrile infection) and gastrointestinal disorders (e.g. anastomotic leak, ulcerative gastritis). The combination exhibited comparable but fewer ADRs than monotherapies, excluding pneumothorax and hypertension. Certain ADRs showed higher incidence and shorter median onset time (3 days post-treatment). CONCLUSIONS: Combination therapy demonstrates manageable safety with early monitoring, though stricter criteria for ADR detection may overlook rare events. Key risks align with monotherapy profiles, emphasizing vigilance for infection-related and gastrointestinal complications. Further studies are warranted to validate these pharmacovigilance findings.
Cardiovascular adverse events associated with EGFR and HER2 dual TKIs: a pharmacovigilance study based on the FAERS database.
Qin H, Teng Y, Yu P … +2 more , Ning Z, Liu J
Expert Opin Drug Saf · 2025 Apr · PMID 40195028 · Publisher ↗
BACKGROUND: EGFR and HER2 dual TKIs have been approved for the treatment of advanced breast cancer in patients who are HER2-positive for second and/or third-line treatment. However, there is a lack of attention to the ca...
BACKGROUND: EGFR and HER2 dual TKIs have been approved for the treatment of advanced breast cancer in patients who are HER2-positive for second and/or third-line treatment. However, there is a lack of attention to the cardiovascular adverse events (AEs) caused by EGFR and HER2 dual TKIs. RESEARCH DESIGN AND METHODS: We analyzed data spanning between March 2007 and June 2024 using the FAERS database and the reporting odds ratio, proportional reporting ratio, and Bayesian confidence propagation neural network to perform disproportionality analysis. RESULTS: Compared with non-cardiovascular AEs, cardiovascular AEs were associated with more severe clinical outcomes, such as higher rates of hospitalization, life-threatening events, disability, and death. Our analysis revealed that lapatinib had a higher-than-expected reporting rate for three SMQs, including cardiac failure, embolic and thrombotic events, and cardiomyopathy. No significant cardiovascular signals were observed for neratinib. CONCLUSION: Disproportionality analysis results revealed a positive signal for cardiac failure, embolic and thrombotic events, and cardiomyopathy of lapatinib, and no positive signal for neratinib. We should pay attention to high-risk signals in clinical practice and monitor them appropriately.
A real-world disproportionality analysis of cidofovir from the FDA Adverse Event Reporting System (FAERS) database.
Liu C, Wang X, Zhou C … +1 more , Cao X
Expert Opin Drug Saf · 2025 Apr · PMID 40193180 · Publisher ↗
BACKGROUND: Cidofovir, an antiviral drug used to treat cytomegalovirus retinitis in AIDS patients. While effective against several viruses, cidofovir's nephrotoxicity and other adverse events (AEs) limit its broader use....
BACKGROUND: Cidofovir, an antiviral drug used to treat cytomegalovirus retinitis in AIDS patients. While effective against several viruses, cidofovir's nephrotoxicity and other adverse events (AEs) limit its broader use. This study aims to evaluate the AE profile of cidofovir using data from the FAERS database. RESEARCH DESIGN AND METHODS: An analysis of FAERS data from the first quarter of 2004 to the fourth quarter of 2023 was performed. Signal detection was conducted using four algorithms: ROR, PRR, BCPNN, and EBGM. Data were categorized by system organ classes (SOCs) and preferred terms (PTs), and the strength of association between cidofovir and AEs was assessed. RESULTS: 1,874 AE reports involving 1,266 patients were identified. 'Renal and urinary disorders,' 'Infections and infestations,' and 'Immune system disorders' were the most frequently reported SOCs, with the highest signal detected for 'Renal and urinary disorders.' Off-label use was the most common PT, highlighting the importance of controlling the indication of medication in clinical practice. CONCLUSION: This study identified significant signals related to cidofovir, suggesting that clinicians should carefully monitor patients, especially when using cidofovir for off-label purposes to mitigate potential risk outcomes. Further research is needed to optimize the safe and effective use of cidofovir.
Adverse event signal analysis of type Ib MET tyrosine kinase inhibitors based on food and drug administration adverse event reporting system.
Wang J, Ma R, Qu B … +1 more , Li X
Expert Opin Drug Saf · 2025 Apr · PMID 40177930 · Publisher ↗
BACKGROUND: Type Ib MET Tyrosine Kinase Inhibitors (TKIs), such as capmatinib, tepotinib, and savolitinib, are used to treat MET-amplified and MET exon 14 deletion mutant non-small cell lung cancer. This pharmacovigilanc...
BACKGROUND: Type Ib MET Tyrosine Kinase Inhibitors (TKIs), such as capmatinib, tepotinib, and savolitinib, are used to treat MET-amplified and MET exon 14 deletion mutant non-small cell lung cancer. This pharmacovigilance study analyzed data from the FDA Adverse Event Reporting System (FAERS) between September 2014 and March 2024 to assess adverse events (AEs) for these FDA-approved drugs. RESEARCH DESIGN AND METHODS: We conducted a systematic search of AEs using MedDRA SMQs by SOC and PT, and performed disproportionality analysis to identify safety signals, calculating ROR, PRR, EBGM, and IC. RESULTS: The analysis identified significant safety signals: capmatinib showed signals for ear and labyrinth disorders, neoplasms, general disorders, and hepatobiliary disorders; tepotinib for renal and urinary disorders, ear and labyrinth disorders, metabolism and nutrition disorders, and general disorders; savolitinib for hepatobiliary disorders. Key PT signals included protein deficiency, scrotal edema, and chylothorax for capmatinib; edema and decreased blood albumin for tepotinib; and abnormal hepatic function for savolitinib. CONCLUSION: The study highlights differences in the safety profiles of Type Ib MET TKIs, underscoring the need for further regulatory review and possible updates to product labels to better inform clinicians and patients.
Exploration of cardiac adverse events associated with relugolix and degarelix: a multi-center pharmacovigilance study based on the FAERS database.
Lv M, Chen J, Zheng B … +2 more , Lin B, Liu M
Expert Opin Drug Saf · 2025 Apr · PMID 40177731 · Publisher ↗
BACKGROUND: Relugolix and degarelix are gonadotropin-releasing hormone antagonist. However, the cardiac safety of relugolix and degarelix in the real world remains uncertain. The purpose of this study was to explore the...
BACKGROUND: Relugolix and degarelix are gonadotropin-releasing hormone antagonist. However, the cardiac safety of relugolix and degarelix in the real world remains uncertain. The purpose of this study was to explore the potential association of relugolix and degarelix with cardiac adverse events (AEs). METHODS: We queried the FAERS database and selected AE reports with relugolix or degarelix as the first suspected drug for analysis. Reporting odds ratio (ROR) and empirical Bayes geometric mean (EBGM) were used to quantify the association between relugolix and degarelix and cardiac AEs. RESULTS: A total of 5,598 and 372 AEs were reported for relugolix and degarelix, respectively, with 235 and 56 being cardiac AEs. The cardiac AEs associated with relugolix and degarelix predominantly occurred in elderly patients (>65 years). Disproportionality analysis showed that relugolix was significantly associated with electrocardiogram/heart rate abnormality and palpitations, with the strongest signal for electrocardiogram abnormality (ROR = 77.54, EBGM = 68.64). While degarelix was significantly associated with cardiac failure, myocardial Infarction, and arrhythmia, with cardiac failure showing the strongest signal (ROR = 8.62, EBGM = 97.71). CONCLUSIONS: There are differences in the types of cardiac adverse events induced by relugolix and degarelix. Clinicians should consider their differences and enhanced electrocardiogram monitoring when prescribing GnRH antagonists to their patients.
Real-world data analysis of topotecan in combination with Bevacizumab or CycloPhosphamide in the FDA adverse event reporting system (FAERS) database.
Chen H, Zhuang G, Hong S … +1 more , Wu J
Expert Opin Drug Saf · 2025 Apr · PMID 40172256 · Publisher ↗
BACKGROUND: The main purpose of this study is to observe and detect adverse reactions to the combination of topotecan, bevacizumab and cyclophosphamide, to learn more about possible adverse drug reactions (ADRs) and to h...
BACKGROUND: The main purpose of this study is to observe and detect adverse reactions to the combination of topotecan, bevacizumab and cyclophosphamide, to learn more about possible adverse drug reactions (ADRs) and to help doctors make the right medication decisions and treatment plans. RESEARCH DESIGN AND METHODS: Adverse event signals were detected and quantified using data from the U.S. Food and Drug Administration's Adverse Event Reporting System using reporting ratios, proportions of reports (PRR), Bayesian Confidence Propagation Neural Networks (BCPN), and empirical Bayesian Geometric Mean (EBGM). Subgroup analyses were performed to compare adverse events associated with topotecan alone. RESULTS: The analysis of FAERS data revealed a total of 1,789 primary suspected adverse events (PS AEs) linked to topotecan. The Weibull shape parameter (β) for females was lower than for males across all age groups, indicating a potentially higher susceptibility to the adverse effects of topotecan in female patients. CONCLUSIONS: This study proved several expected and new adverse drug reactions associated with the combination of topotecan, bevacizumab, and cyclophosphamide. While some ADRs, such as neutropenia and anemia, align with the known adverse profile of topotecan, the detection of novel signals, including potential gender-based differences in drug response, warrants further investigation.
Analysis of diroximel fumarate data for patients with relapsing forms of multiple sclerosis using related adverse events from the FDA adverse reporting system.
Yang JY, Sun SZ, Sun YY … +5 more , Zuo TQ, Li XT, Zhao LY, Wu HY, Peng W
Expert Opin Drug Saf · 2025 Apr · PMID 40171720 · Publisher ↗
BACKGROUND: Diroximel fumarate (DRF) is an oral fumarate used to treat relapsing forms of multiple sclerosis (RMS). This study comprehensively analyzed the adverse events (AEs) associated with DRF for treating RMS based...
BACKGROUND: Diroximel fumarate (DRF) is an oral fumarate used to treat relapsing forms of multiple sclerosis (RMS). This study comprehensively analyzed the adverse events (AEs) associated with DRF for treating RMS based on data from the FDA Adverse Event Reporting System (FAERS) database. RESEARCH DESIGN AND METHODS: This study collected data on AEs associated with DRF treatment of RMS from the FAERS database between 2019 and 2024. We used reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS) for signal detection. RESULTS: This study collected 7,944,554 AE reports, of which 7,868 were associated with DRF. A total of 120 preferred terms (PTs) were included in the analysis, relating to 27 system organ classes (SOCs). This study identified several clinically significant new potential AEs, including decreased immune responsiveness ( = 26, ROR 4.45, PRR 4.45, IC 2.15, EBGM 4.43), female breast cancer ( = 50, ROR 4.07, PRR 4.07, IC 2.02, EBGM 4.05), transient blindness ( = 19, ROR 7.27, PRR 7.26, IC 2.85, EBGM 7.21) and others. CONCLUSIONS: Our study identified several potentially important AEs that were not mentioned in the DRF instructions. However, further epidemiologic studies are needed to validate these findings.
A disproportionality analysis of hydrocortisone-related adverse events: a real-world pharmacovigilance study using the FAERS database.
Wang X, An F, Zhao X … +3 more , Wang B, Yan L, Han W
Expert Opin Drug Saf · 2025 Apr · PMID 40163037 · Publisher ↗
BACKGROUND: This study aims to systematically evaluate adverse events (AEs) associated with hydrocortisone through the FDA Adverse Event Reporting System (FAERS) database. RESEARCH DESIGNS: AE reports associated with hyd...
BACKGROUND: This study aims to systematically evaluate adverse events (AEs) associated with hydrocortisone through the FDA Adverse Event Reporting System (FAERS) database. RESEARCH DESIGNS: AE reports associated with hydrocortisone from Q1 2014 to Q4 2023 were extracted from the FAERS database. Multiple disproportionality analysis techniques, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM), were employed for signal detection. In addition, we also analyzed the time to onset of AEs. RESULTS: Analysis of 7,532 hydrocortisone-associated AEs from the FAERS database revealed significant signals across multiple system organ classes. The strongest associations were found in endocrine disorders (ROR: 13.39), ear and labyrinth disorders (ROR: 3.05), and immune system disorders (ROR: 2.17). Additionally, the study uncovered unexpected AEs such as splenic peliosis and lymphoid tissue hypoplasia. 63.9% of the AEs occurred within 7 days of treatment. CONCLUSIONS: Based on disproportionality analysis of FAERS data, this study provides new insights into the safety of hydrocortisone in the real-world setting. Future prospective studies should be conducted to validate the findings of this investigation.
Adverse events associated with obeticholic acid: a real-world, pharmacovigilance study.
Zhang C, Wang J
Expert Opin Drug Saf · 2025 Apr · PMID 40162628 · Publisher ↗
BACKGROUND: Primary biliary cholangitis (PBC) is a chronic autoimmune liver disease predominantly affecting middle-aged women. While ursodeoxycholic acid (UDCA) is the first-line treatment, 30-40% of patients do not resp...
BACKGROUND: Primary biliary cholangitis (PBC) is a chronic autoimmune liver disease predominantly affecting middle-aged women. While ursodeoxycholic acid (UDCA) is the first-line treatment, 30-40% of patients do not respond adequately, necessitating alternative therapies like Obeticholic Acid (OCA), an FXR agonist. The long-term safety of OCA remains insufficiently studied. RESEARCH DESIGN AND METHODS: This study utilized the US FDA Adverse Event Reporting System (FAERS) to evaluate OCA safety through large-scale data mining, using disproportionality analyses (ROR, PRR, BCPNN, and MGPS) to identify adverse event signals. RESULTS: From Q2 2016 to Q1 2024, 5,864 reports linked to OCA usage were identified among 13,245,871 AE reports. Significant signals across 27 System Organ Classes were found, with pruritus (12.54%), fatigue (4.16%), and nausea (1.64%) being the most prevalent adverse events. Severe hepatic events like liver failure were rare (0.6%). Median time to onset of AEs was 178 days. The most common outcomes reported were important medical events (18.6%), hospitalization (17.8%), and death (6.5%). CONCLUSION: This study provides key insights into the safety profile of OCA, highlighting the importance of monitoring for pruritus and hepatic complications, particularly within the first six months of treatment.
Adverse drug reactions linked to fidaxomicin: insights from a retrospective analysis of the FAERS database.
Patel P, Ebrahim MA, Adler DG
Expert Opin Drug Saf · 2025 Mar · PMID 40162491 · Publisher ↗
BACKGROUND: infection is a leading healthcare-associated infection, and fidaxomicin is recommended as a first-line treatment. Although generally well-tolerated, post-marketing surveillance of fidaxomicin's safety profil...
BACKGROUND: infection is a leading healthcare-associated infection, and fidaxomicin is recommended as a first-line treatment. Although generally well-tolerated, post-marketing surveillance of fidaxomicin's safety profile is necessary given its increased utilization. RESEARCH DESIGN AND METHODS: This study utilized the FDA Adverse Event Reporting System to analyze adverse drug reactions potentially linked to fidaxomicin use from January 2011 to June 2024. Data were extracted on patient demographics, reported ADRs, and outcomes. Descriptive statistics were used to analyze the ADR reports. RESULTS: A total of 1,187 reports of ADRs were analyzed, including 122 deaths (10.3%), 187 hospitalizations (15.8%), and 17 disabilities (1.4%). The most commonly reported ADRs were gastrointestinal (33%) in nature. Neurological ADRs accounted for 6% of reports, with dizziness and headache being the most prevalent. Psychiatric ADRs such as insomnia and anxiety were reported in 2.8% of cases, with more than half considered serious. Cardiovascular ADRs, though infrequent (2.2%), were largely severe, with heart failure and arrhythmias being the most common. CONCLUSION: While fidaxomicin is generally well-tolerated, our study identified rare but serious neuropsychiatric and cardiovascular ADRs. Further research is needed to investigate these effects and ensure informed, shared decision-making between prescribers and patients.
Adverse events of celecoxib associated with the central nervous system and cancer: a disproportionality analysis of the FDA adverse event reporting system.
Du Y, Zhang M, Chen M … +8 more , Hu M, Zeng W, Cai X, Zhang W, Zhu J, Zhong M, Liu Y, Yang C
Expert Opin Drug Saf · 2025 Apr · PMID 40159988 · Publisher ↗
BACKGROUND: Celecoxib is now clinically recognized as a candidate for treating various neurological disorders and cancers. The recent emergence of some serious adverse reactions is concerning. RESEARCH DESIGN AND METHODS...
BACKGROUND: Celecoxib is now clinically recognized as a candidate for treating various neurological disorders and cancers. The recent emergence of some serious adverse reactions is concerning. RESEARCH DESIGN AND METHODS: We carried out data mining on the FDA Adverse Event Reporting System (FAERS) for adverse events (AEs) with celecoxib as the main suspect drug and conducted a disproportionality analysis. RESULTS: 111,155,092 AE reports were extracted from FAERS, and 32,841 AEs with celecoxib as the primary suspected drug were identified. Celecoxib AEs were predominantly reported in cardiac disorders ( = 9602) and nervous system disorders ( = 4045). Cerebrovascular accident ( = 3109, PRR = 3.24) ranked second in the number of reports and cerebrovascular disorder ( = 265, PRR = 5.06) ranked second in signal intensity, was described as rare in the instructions. Nine unexpected and serious AEs were discovered, such as Stevens-Johnson syndrome ( = 175, IC025 = 1.7), breast disease male ( = 4, IC025 = 1.54), and squamous cell carcinoma of the head and neck ( = 4, IC025 = 0.96). At 200 mg, celecoxib was more linked to musculoskeletal and connective AEs; At 400 mg, it was more linked to neurological and cardiovascular AEs. CONCLUSIONS: Unexpected AEs of celecoxib in neurological diseases and cancer have been identified, offering valuable insights for monitoring and risk assessment in future clinical applications.
Influence factors of metronidazole-related CNS disorders: an analysis of the Japan adverse drug event report and FDA adverse event reporting system.
Takada K, Enoki Y, Samura M … +4 more , Igarashi Y, Taguchi K, Tanikawa K, Matsumoto K
Expert Opin Drug Saf · 2025 Apr · PMID 40159088 · Publisher ↗
BACKGROUND: Metronidazole (MNZ) can be administered for various infections. The impact of comorbidities/concomitant drugs on MNZ-induced central nervous system (CNS) disorders remains unclear. RESEARCH DESIGN AND METHODS...
BACKGROUND: Metronidazole (MNZ) can be administered for various infections. The impact of comorbidities/concomitant drugs on MNZ-induced central nervous system (CNS) disorders remains unclear. RESEARCH DESIGN AND METHODS: We assessed the risk of metronidazole-related CNS disorders using the Japan Adverse Drug Event Report (JADER, May 2023) and the US Food and Drug Administration Adverse Event Reporting System (FAERS, Q1 2023), excluding comorbidities/concomitant drugs. Clonazepam and diazepam were evaluated as potential prophylactics based on the efficacy of benzodiazepines for MNZ-related CNS disorders. Reporting odds ratios (ROR) and 95% confidence intervals (CI) were calculated. Additionally, sensitivity analysis by sex and age was conducted. RESULTS: The ROR (95% CI) of CNS disorders associated with MNZ in JADER and FAERS were 3.16 (2.69-3.72) and 1.69 (1.64-1.73), respectively. MNZ was significantly related to CNS disorders after excluding comorbidities (brain/spinal cord or liver abscesses) and concomitant drugs (glucocorticoids, antiepileptic, antiparkinson, and schizophrenia drugs). In sensitivity analysis, MNZ was significantly related to CNS disorders, despite sex and age. The ROR in the concomitant with clonazepam (CZP) was 0.70 (0.53-0.92) in FAERS. CONCLUSION: MNZ may be associated with CNS disorders, even if comorbidities/concomitant drugs that are potential risk factors for CNS disorders are excluded. Additionally, CZP may suppress CNS disorders.
Infection toxicity assessment of tumor necrosis factor α inhibitors in the treatment of IBD: a real-world study based on the US food and drug administration adverse events reporting system (FAERS).
Cheng Q, Yao Z, Shi X … +4 more , Zou S, Zhao Y, Ouyang M, Sun M
Expert Opin Drug Saf · 2025 Mar · PMID 40156444 · Publisher ↗
BACKGROUND: Tumor necrosis factor α (TNF-α) inhibitors are widely used to treat inflammatory bowel disease (IBD), but systematic risk assessment of infectious toxicity is still lacking. RESEARCH DESIGN AND METHODS: We us...
BACKGROUND: Tumor necrosis factor α (TNF-α) inhibitors are widely used to treat inflammatory bowel disease (IBD), but systematic risk assessment of infectious toxicity is still lacking. RESEARCH DESIGN AND METHODS: We used disproportional analysis to calculate infection-related risk signals for four TNF-α inhibitors and compared them with infection-related signals for seven other therapies. RESULTS: There were 55,379 reports of infection-related adverse events (AEs) with TNF-α inhibitors as a 'primary suspect (PS)' therapy. The median time to onset of infection-related AEs was 113 days (interquartile range [IQR] 14-612). TNF-α inhibitors present the strongest infectious toxic signal than interleukin 12/23 (IL-12/23) inhibitors, integrin blockers, Jak inhibitors, and S1P receptor modulator. Compared with infliximab, certolizumab pegol, and adalimumab, golimumab showed the strongest signal. The strongest signal corresponding to appendicitis, pulmonary tuberculosis, pneumonia, sepsis, urinary tract infection, otitis media and herpes zoster is golimumab, infliximab, golimumab, natalizumab, certolizumab pegol, infliximab, and infliximab. CONCLUSIONS: Compared with other control therapies, TNF-α inhibitors have the strongest infectious toxicity signal. Compared with other TNF-α inhibitors, golimumab has the strongest infectious toxicity signal. When using TNF-α inhibitors to treat IBD, infection-related AEs should be vigilant.
Adverse events associated with acute pancreatitis caused by immune checkpoint inhibitors: a pharmacovigilance analysis of the FDA adverse event reporting system (FAERS) database.
Tong L, Yuan Y, He W … +2 more , Yang W, Pan X
Expert Opin Drug Saf · 2025 Mar · PMID 40152025 · Publisher ↗
BACKGROUND: The precise incidence of immune-related adverse events (irAEs) remains unclear. This pharmacovigilance study investigated acute pancreatitis (AP) associated with immune checkpoint inhibitors (ICIs) using real...
BACKGROUND: The precise incidence of immune-related adverse events (irAEs) remains unclear. This pharmacovigilance study investigated acute pancreatitis (AP) associated with immune checkpoint inhibitors (ICIs) using real-world data from the FDA Adverse Event Reporting System (FAERS). RESEARCH DESIGN AND METHODS: Disproportionality analysis employing reporting odds ratios (RORs) was conducted to detect AP signals in ICI-treated patients compared to the entire FAERS database. RESULTS: A total of 152,042 individual patients were included in the dataset from which we identified a cohort of 921 acute pancreatitis adverse events (AEs). The severe outcome of acute pancreatitis was death, with a rate of 13.6% (125/921). Immune checkpoint inhibitor (ICI)-related acute pancreatitis AEs were classified into two categories (pancreatitis and immune-mediated pancreatitis) based on the type of adverse event observed. ICI treatments were significantly correlated with the risk of ICIs-induced acute pancreatitis (AP) but varied among different drugs. The median time to AP onset was 57 days, with events occurring throughout the first year post-ICI initiation. CONCLUSIONS: Our findings provide an enhanced understanding of potential acute pancreatitis related adverse events and provide actionable insights for the early detection and management of ICI related pancreatic adverse events.
Post-marketing safety associated with sodium zirconium cyclosilicate: a pharmacovigilance study based on the FDA reporting system.
Chen J, Lu Z, Luo H … +2 more , Wang T, Qin X
Expert Opin Drug Saf · 2025 Mar · PMID 40151141 · Publisher ↗
BACKGROUND: Sodium zirconium cyclosilicate (SZC) is a novel oral therapy for hyperkalemia with limited adverse reactions documented on its label. Accordingly, the objective of this study was to investigate real-world adv...
BACKGROUND: Sodium zirconium cyclosilicate (SZC) is a novel oral therapy for hyperkalemia with limited adverse reactions documented on its label. Accordingly, the objective of this study was to investigate real-world adverse events (AEs) associated with SZC using the FDA Adverse Event Reporting System (FAERS). RESEARCH DESIGN AND METHODS: Relevant data regarding SZC were extracted from FAERS, and signal detection was conducted using four distinct algorithms. The Weibull shape parameter characterized the AE onset time. Kaplan-Meier analysis was used to evaluate the cumulative incidence of AEs associated with SZC. RESULTS: Among 8,846,085 case reports recorded in the FAERS database, 1,160 SZC-related AEs were identified. Beyond AEs, such as hypokalemia, edema, constipation, and ileus, listed on the SZC label, 26 additional positive risk signals were not stated, including X-ray gastrointestinal tract abnormal, cardiac failure, and aspiration pneumonia. The median onset time of SZC-related AEs was 42 days. Furthermore, AEs differed between male and female patients. CONCLUSIONS: This study confirmed SZC label safety warnings and identified new AEs, offering insights for clinical monitoring of SZC.
Pharmacovigilance study and genetic target prediction analysis of FDA adverse event reports (FAERS) for drug-induced sinusitis.
Wang E, Sun Y, Zhao H … +1 more , Cao Z
Expert Opin Drug Saf · 2025 Apr · PMID 40128146 · Publisher ↗
BACKGROUND: Drug-induced sinusitis has been widely reported as an adverse drug reaction in recent years, yet the pharmacogenetic mechanisms and risk factors associated with sinusitis remain elusive. OBJECTIVE: We aimed t...
BACKGROUND: Drug-induced sinusitis has been widely reported as an adverse drug reaction in recent years, yet the pharmacogenetic mechanisms and risk factors associated with sinusitis remain elusive. OBJECTIVE: We aimed to identify the major drugs reported in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) in relation to sinusitis and to analyze their pharmacogenetic mechanisms through drug target analysis. METHODS: We conducted a review of the publicly available FAERS database from 2004 to the third quarter of 2023. We extracted genetic tools corresponding to each drug, utilized colocalization analysis, Mendelian randomization (MR) analysis, and cross-tissue drug target analysis to predict the impact of drug targets on sinusitis. RESULTS: Following the validation of drug-related risks, a total of 13 medications were ultimately identified, including TNF inhibitors: pomalidomide (ROR: 14.77), certolizumab pegol(ROR: 8.21), etanercept (ROR: 7.961), lenalidomide (ROR: 6.998), adalimumab (ROR: 6.677), infliximab (ROR: 3.939); C4B-targeted drugs: human immunoglobulin G (ROR:3.846) and other risk drugs were commonly reported. Co-localization analysis and MR analysis suggests associations between TNF, C4B, and LTA and sinusitis. CONCLUSION: We demonstrated the risk of sinusitis associated with 13 drugs, including pomalidomide, and the impact of TNF and C4B drugs on sinusitis, which provides guidance for the use of related drugs and the prevention of sinusitis.
An updated safety review of Hidradenitis Suppurativa treatment options.
Cascio Ingurgio R, Ibba L, Alfano A … +3 more , Narcisi A, Costanzo A, Valenti M
Expert Opin Drug Saf · 2025 Oct · PMID 40125932 · Publisher ↗
INTRODUCTION: Moderate-to-severe hidradenitis suppurativa (HS) is a chronic inflammatory condition with a significant impact on patients' quality of life. Recent advancements in biologics and small-molecule therapies off...
INTRODUCTION: Moderate-to-severe hidradenitis suppurativa (HS) is a chronic inflammatory condition with a significant impact on patients' quality of life. Recent advancements in biologics and small-molecule therapies offer new treatment options by targeting diverse inflammatory pathways. AREAS COVERED: This review evaluates the safety profiles of key biologics and small molecules based on Phase 2 and 3 clinical trials. Infection-related adverse events (AEs) were the most common, particularly with IL-17 inhibitors. Mild gastrointestinal and neurological AEs occurred frequently, while serious AEs were rare, indicating an overall acceptable safety profile. EXPERT OPINION: Emerging therapies such as IL-17 inhibitors (bimekizumab), IL-36 inhibitors (spesolimab), and small molecules like the JAK inhibitor povorcitinib provide promising alternatives for patients unresponsive to conventional treatments. Personalized treatment plans integrating biologics, small molecules, and adjunctive therapies are crucial for optimal outcomes. Challenges remain, including diagnostic delays, economic barriers, and the need for real-world evidence to validate long-term safety and efficacy. Advancing precision medicine, improving early diagnosis, and adopting comprehensive care models will enhance HS management and patients' quality of life.
Comparative analysis of CDKI-related adverse events in older patients: a real-world data from the FDA adverse event reporting system database.
Fang Q, Huang F, Zhao H … +5 more , Liang J, Chen Y, Wu X, Zhang M, Luo W
Expert Opin Drug Saf · 2025 Mar · PMID 40107713 · Publisher ↗
BACKGROUND: Cyclin-dependent kinase 4 and 6 inhibitors (CDKIs) are effective and safe against advanced and metastatic breast cancer; however, limited information is available for older patients. We conducted an analysis...
BACKGROUND: Cyclin-dependent kinase 4 and 6 inhibitors (CDKIs) are effective and safe against advanced and metastatic breast cancer; however, limited information is available for older patients. We conducted an analysis of real-world data pertaining to the safety of older patients using the Adverse Event Reporting System (FAERS) database of the FDA. RESEARCH DESIGN AND METHODS: We performed a disproportionality analysis to evaluate CDKI-related adverse events (AEs) in older adults administered abemaciclib, palbociclib, and ribociclib. RESULTS: Data were from 2132, 36916, and 4328 case reports on abemaciclib, palbociclib, and ribociclib in older patients, respectively. Disproportionality analysis revealed 242, 295, and 439 drug-AE signals. The numbers of system organ classes (SOC) for abemaciclib, palbociclib, and ribociclib were 25, 27, and 26, respectively. We found several expected AE signals consistent with those in the drug instructions, such as nausea, neutropenia, and fatigue, for all CDKIs. Interstitial lung disease, thromboembolic events, and cardiac toxicity were also noteworthy. Unexpected AE signals, such as acute kidney injury, atrial fibrillation, and memory impairment associated with abemaciclib, ribociclib, and palbociclib, respectively, were identified. CONCLUSION: Our results aligned with clinical observations, emphasizing possible CDKI-related AEs. Conducting future clinical research is essential to confirm AE-related differences among CDKIs in older individuals.
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