Expert Opinion On Drug Safety[JOURNAL]
Sun
200 papers
Safety of edaravone in real-world use: analysis based on FDA adverse event reporting system.
Peng T, Hu N, Huang L … +6 more , Kang Y, Yan Y, Zhang H, Wan D, Jin X, Yang Y
Expert Opin Drug Saf · 2026 Jul · PMID 39982214 · Publisher ↗
BACKGROUND: Edaravone is a novel free radical scavenger utilized to treat amyotrophic lateral sclerosis (ALS). However, long-term safety data remain limited. RESEARCH DESIGN AND METHODS: Adverse event reports related to...
BACKGROUND: Edaravone is a novel free radical scavenger utilized to treat amyotrophic lateral sclerosis (ALS). However, long-term safety data remain limited. RESEARCH DESIGN AND METHODS: Adverse event reports related to edaravone from the second quarter of 2017 to the second quarter of 2024 were extracted from the US Food and Drug Administration (FDA) Adverse Event Reporting System database (FAERS). Disproportionality analysis was conducted utilizing the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) algorithms. RESULTS: A total of 3,149 adverse event reports related to edaravone were analyzed. The most common adverse reactions included systemic disorders and administration site reactions, nervous system disorders, respiratory system disorders, and surgical and medical procedures. New adverse reaction signals included disseminated intravascular coagulation, gastric fistula, sputum retention, excessive salivation, fractures, elevated cystatin C. The median onset time for adverse events was 43 days (interquartile range: 7-173 days). CONCLUSION: This study confirmed previously reported adverse events and identified several new ones associated with edaravone. These findings provide valuable insights for optimizing ALS patient management and highlight the need for further research into the mechanisms of these adverse reactions.
Adverse events associated with inclisiran: a real-world pharmacovigilance study of FDA adverse event reporting system (FAERS).
Li B, Chen Y, Zhang Y … +4 more , Qian M, Shan Q, Qian J, Guo J
Expert Opin Drug Saf · 2026 Apr · PMID 39980209 · Publisher ↗
OBJECTIVE: To gain an improved comprehension of inclisiran safety in real-world settings by data mining from FAERS. METHODS: Data were gathered between 1 December 2020 and 31 December 2023. The Medical Dictionary for Reg...
OBJECTIVE: To gain an improved comprehension of inclisiran safety in real-world settings by data mining from FAERS. METHODS: Data were gathered between 1 December 2020 and 31 December 2023. The Medical Dictionary for Regulatory Activities (MedDRA) corresponding preferred term (PT) and system organ class (SOC) were used to categorize adverse medication reactions in AE reports (AERs). By using reported odds ratio (ROR) method, positive signals were identified. RESULTS: There were 2,652 reports of inclisiran, and 150 of those AEs had significant disproportionality. Among the 44 PTs with moderate clinical priority, 35 PTs were discovered on the medicine label, including 12 IMEs and 2 DMEs. Of note, 9 PTs were unanticipated AEs that were not discovered in the medication label or reported clinical studies, such as movement disorder (ROR: 3.05; 95%CI: 1.73,5.37), aphonia (ROR: 3.77; 95%CI: 1.79,7.91), and pulmonary congestion (ROR: 3.47; 95%CI: 1.44,8.34). Inclisiran was found to be related to 12 serious AEs. The median TTO of 1896 cases was 13.5 (IQR 0-100) days. CONCLUSION: We identified not only known AEs, but also new AE signals such as movement disorder. However, signals does not reveal actual risk, prospective clinical trials are still required to verify their causal connection.
Drug-induced hypokalemia: an analytical study based on real-world drug monitoring data.
Song B, Liu L, Dong S … +1 more , Wang S
Expert Opin Drug Saf · 2026 May · PMID 39977281 · Publisher ↗
BACKGROUND: Drug-induced hypokalemia is often associated with adverse clinical outcomes, and unfortunately, the inability to fully understand the drugs that cause hypokalemia puts us in a passive position. This study app...
BACKGROUND: Drug-induced hypokalemia is often associated with adverse clinical outcomes, and unfortunately, the inability to fully understand the drugs that cause hypokalemia puts us in a passive position. This study applies pharmacovigilance data to present a panorama of suspected medications associated with hyperkalemia. RESEARCH DESIGN AND METHODS: This study used disproportionality analysis to mine adverse events in OpenFDA, identified all suspected drugs that caused hypokalemia, and coded and classified the suspected drugs according to the Anatomical Therapeutic Chemical (ATC) classification system. RESULTS: There are 19755 reports related to drug-induced hypokalemia. The majority of individuals with hypokalemia are females, with a concentrated age range of 65 to 84 years old. After the occurrence of hypokalemia, 8.02% died due to hypokalemia. This study identified 1141 suspected drugs, and among the top 50 drugs, 32 drugs did not include hypokalemia in their instructions. All suspected drugs can be categorized into 73 subgroups according to the ATC classification system. CONCLUSIONS: By mining the OpenFDA database, we have identified all suspected drugs that cause hypokalemia and conducted a comprehensive evaluation. The instructions for most of the suspected drugs do not focus on hypokalemia. When the treatment regimen includes other drugs that can directly/indirectly cause a decrease in blood potassium, we recommend actively monitoring blood potassium when using suspected drugs.
Incidence and risk of treatment-related fatal adverse events in cancer patients treated with antibody conjugated drugs: a systematic review and meta-analysis of randomized controlled trials.
Huang Z, Li X, Zhou X … +5 more , Yang Z, Huo X, Zhu J, Li S, Jiang J
Expert Opin Drug Saf · 2026 Jul · PMID 39976269 · Publisher ↗
INTRODUCTION: Antibody-drug conjugates (ADCs) have radically transformed the therapeutic landscape for cancer treatment, but little is known about the treatment-related fatal adverse events (FAEs). We aimed to comprehens...
INTRODUCTION: Antibody-drug conjugates (ADCs) have radically transformed the therapeutic landscape for cancer treatment, but little is known about the treatment-related fatal adverse events (FAEs). We aimed to comprehensively investigate the safety of ADCs regarding treatment-related FAEs. METHODS: We conducted a systematic search of PubMed, Embase, and the Cochrane database for randomized controlled trials (RCTs) of ADCs. The meta-analysis assessed the incidence of treatment-related FAEs and the odds ratio (OR) in the ADCs group compared with the control group. RESULTS: A total of 49 RCTs involving 13,052 patients treated with ADCs were included. The incidence of treatment-related FAEs in the ADCs group was 0.62% (95% CI = 0.36-1.08), while the control group was 0.52% (95% CI = 0.29-0.95), with an OR of 1.41 (95% CI = 1.12-1.79; < 0.05). In the subgroup analysis by drug and cancer type, gemtuzumab ozogamicin, which for acute myeloid leukemia were associated with a higher risk of treatment-related FAEs compared to controls (OR = 1.63; 95% CI = 1.12-2.36; < 0.05). There was no evidence of publication bias observed. CONCLUSIONS: The meta-analysis of RCTs found that ADCs were associated with an increased risk of treatment-related FAEs compared with the control group. Moreover, the occurrence of treatment-related FAEs was associated with specific types of ADCs.
Hospital-wide interventions for reducing or preventing in-hospital prescribing errors: a scoping review.
Mahomedradja RF, Wang S, Catherina Eve Sigaloff K … +2 more , Tichelaar J, Adriaan van Agtmael M
Expert Opin Drug Saf · 2025 May · PMID 39973626 · Publisher ↗
INTRODUCTION: Prescribing errors (PEs) in hospital care lead to patient harm, prolonged hospital stays, readmissions, and mortality. Despite interventions that successfully target 'high risk' populations in trials, PE ra...
INTRODUCTION: Prescribing errors (PEs) in hospital care lead to patient harm, prolonged hospital stays, readmissions, and mortality. Despite interventions that successfully target 'high risk' populations in trials, PE rates remain largely unchanged in real-world settings. Existing studies often focus narrowly on specific populations, overlooking the wider complexities of hospital-wide prescribing. This scoping review evaluates interventions for adult inpatients to identify knowledge gaps in how to reduce in-hospital PEs. METHODS: A systematic search of PubMed, EMBASE.com, and the Cochrane Library (inception to 13 December 2024) was conducted following PRISMA-ScR guidelines. Studies prospectively evaluating interventions reducing in-hospital PEs were eligible for inclusion; those focusing on specific drugs, wards or populations or lacking original data were excluded. RESULTS: Fourteen studies met the inclusion criteria. Technological interventions, such as computerized order entry systems, accounted for 35.7% of the studies. Half addressed prescriber-related factors, such as inadequate drug knowledge and prescribing skills, while organizational factors were underexplored. CONCLUSION: Current interventions fail to address the underlying complexities, leaving critical gaps to decrease in-hospital PEs. To achieve sustainable PE reductions and improve patient safety, a multidisciplinary approach, standardized reporting, organizational reform, and a Safety-II perspective are essential.
Adverse event profiles of CDK4/6 inhibitors: a disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) database.
Tian X, Chen L, Chen Y … +1 more , Zhang N
Expert Opin Drug Saf · 2026 Jul · PMID 39973332 · Publisher ↗
BACKGROUND: The safety profile of CDK4/6 inhibitors has not yet been systemically analysed in the real world. This study aimed to provide a comprehensive understanding of AEs associated with CDK4/6 inhibitors using the F...
BACKGROUND: The safety profile of CDK4/6 inhibitors has not yet been systemically analysed in the real world. This study aimed to provide a comprehensive understanding of AEs associated with CDK4/6 inhibitors using the FAERS database. METHODS: FAERS data (2014Q1 to 2022Q4) were searched for reports of all FDA-approved CDK4/6 inhibitors across all indications. We used the SMQ generalized search AEs on the PT level. Disproportionality analysis was used to detect safety signals by calculating RORs. RESULTS: Within the standardized MedDRA queries, significant safety signals were found, including those for palbociclib [haematopoietic leukopenia, erythropenia], ribociclib [haematopoietic leukopenia , conduction defects], and abemaciclib [eosinophilic pneumonia, dehydration]. For AEs at the PT level, we found several significant blood and lymphatic system disorders for both palbociclib and ribociclib, such as abnormal full blood count and decreased white blood cell count for palbociclib and anisocytosis, neutropenia for ribociclib. Palbociclib also had high RORs for pseudocirrhosis, stomatitis, oral pain, and alopecia, while ribociclib had high RORs for electrocardiogram PR shortened, sinus arrhythmia, and blood bilirubin abnormal. However, the RORs were significant for abemaciclib in terms of diarrhoea, vena cava thrombosis, thrombophlebitis migrans and pneumonitis. CONCLUSION: CDK4/6 inhibitors differed in their safety profile reports.
What does real-world data reveal about cangrelor's safety? An analysis of FDA adverse event reporting system (FAERS) database.
Wang Z, Zhang J, Shi D … +1 more , Wei L
Expert Opin Drug Saf · 2026 Jul · PMID 39971303 · Publisher ↗
BACKGROUND: Cangrelor is used to reduce thrombotic events in adults undergoing percutaneous coronary intervention, but real-world safety data is limited. This study analyzes adverse events (AEs) related to cangrelor usin...
BACKGROUND: Cangrelor is used to reduce thrombotic events in adults undergoing percutaneous coronary intervention, but real-world safety data is limited. This study analyzes adverse events (AEs) related to cangrelor using the FDA adverse event reporting system (FAERS) database. METHODS: We employed statistical techniques such as the reporting odds ratio, proportional reporting ratio, bayesian confidence propagation neural network, and multi-item gamma poisson shrinker to analyze the data from the FAERS database. RESULTS: Out of a total of 15,011,506 case reports, 209 events were related to cangrelor. Thirty-one preferred term (PT) describing AEs were identified, affecting eight organ systems. The most reported PT was off-label use ( = 163). Several unexpected AEs not listed in the drug labeling emerged, including cardiac arrest, and cardiac failure. Although percutaneous coronary intervention was the most common indication (35.4%), numerous events were associated with off-label use, particularly for conditions such as acute myocardial infarction, antiplatelet therapy, and anticoagulant therapy. CONCLUSION: Our research reveals both anticipated and unexpected AEs, providing important new information on the safety profile of cangrelor. Furthermore, we have discovered certain problems pertaining to product applications. It is recommended that manufacturers clearly highlight indications and usage instructions, and medical personnel closely follow drug administration protocols.
Assessment of adverse events of the novel antiepileptic drug lamotrigine: a real-world pharmacovigilance study based on FAERS.
Tu L, Xiao J, Hong Q … +3 more , Ouyang A, Tu Y, Wang S
Expert Opin Drug Saf · 2025 Jul · PMID 39964316 · Publisher ↗
BACKGROUND: Lamotrigine (LTG), a medication frequently prescribed for epilepsy. Despite its widespread use, there remains a lack of clarity regarding the drug's safety profile when used over extended periods in large pat...
BACKGROUND: Lamotrigine (LTG), a medication frequently prescribed for epilepsy. Despite its widespread use, there remains a lack of clarity regarding the drug's safety profile when used over extended periods in large patient populations. This study evaluated the safety profile of LTG using the FDA Adverse Event Reporting System (FAERS), aiming to enhance clinical decision-making. RESEARCH DESIGN AND METHODS: We used disproportionate analyses, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayes geometric mean (EBGM), to identify signals of adverse reactions associated with LTG. RESULTS: A total of 187,024 records were reported, involving 905 adverse drug event (ADE) signals across 27 system organs classes (SOCs). We detected several known adverse event (AE) signals from the clinical trial phase, including seizures, rash, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Additionally, we uncovered several unforeseen and significant adverse effects that were not documented in the medication's prescribing information, encompassing suicides, atrial septal defects, Brugada syndrome, and signals associated with aortic stenosis. CONCLUSIONS: Our analysis in the post-marketing setting reveals new AE signals associated with LTG, highlighting the need for ongoing risk surveillance.
Evaluating bowel obstruction and ileus events in patients on GLP-1 receptor agonists: a systematic review and meta-analysis.
Alfehaid L, Alyami M, Almohareb S … +2 more , Alshaya O, Almutairi A
Expert Opin Drug Saf · 2026 Jun · PMID 39964295 · Publisher ↗
INTRODUCTION: This research evaluated the association between glucagon-like peptide-1 receptor agonists (GLP-1 RA) and bowel obstruction or ileus. METHODS: We searched databases, including Medline, Embase, and Cochrane,...
INTRODUCTION: This research evaluated the association between glucagon-like peptide-1 receptor agonists (GLP-1 RA) and bowel obstruction or ileus. METHODS: We searched databases, including Medline, Embase, and Cochrane, for studies on adult patients treated with GLP-1 RA. We included randomized control trials (RCT), cohort, case-control studies, and case reports. We used the Cochrane Risk of Bias tool to evaluate the quality of RCTs and the Newcastle-Ottawa Scale for cohort and case-control studies. RESULTS: Out of 317 records identified, 14 studies were included in the systematic review. The meta-analysis included 6 studies with a combined total of 550,426 participants. The use of GLP-1 RA did not show an incremental risk of bowel obstruction or ileus compared to controls (OR 1.95, 95% CI 0.43-8.79). However, the studies had high heterogeneity (I = 94%). A subgroup analysis by specific medication revealed that liraglutide was associated with a significantly high risk of bowel obstruction or ileus (OR 3.0, 95% CI 2.03-4.45; I = 0%). CONCLUSIONS: GLP-1 receptor agonists do not significantly increase the risk of bowel obstruction or ileus. However, liraglutide is associated with a higher risk compared to semaglutide. Clinicians should remain aware of these rare events while recognizing the benefits of GLP-1 receptor agonists for glycemic control and cardiovascular health. PROSPERO REGISTRATION: CRD42024585971.
Drug-induced skin ulcer: real-world pharmacovigilance analysis based on the FDA adverse event reporting system.
Jin Q, Fang J, Ren F … +3 more , Li J, Zhou S, Song P
Expert Opin Drug Saf · 2026 May · PMID 39964057 · Publisher ↗
BACKGROUND: Skin ulcer (SU) may increase the risk of systemic infections and have evolved into an important public health problem. However, there is a lack of research specifically on drug-induced SU. RESEARCH DESIGN AND...
BACKGROUND: Skin ulcer (SU) may increase the risk of systemic infections and have evolved into an important public health problem. However, there is a lack of research specifically on drug-induced SU. RESEARCH DESIGN AND METHODS: We extracted data on adverse drug events (ADEs) associated with SU from the FDA Adverse Event Reporting System (FAERS) database. Disproportionality analysis was performed to calculate the risk signals for drugs that may induce SU. Logistic regression analysis was carried out to investigate the factors influencing the occurrence of SU. RESULTS: 21372 cases of SU were reported in FAERS database between 2005 and 2024. Based on the frequency of ADE reports, we compiled a list of the top 50 drugs associated with SU. Only 15 drugs had explicit mentions of SU in their instructions, while 32 drugs were recognized as positive signals for SU by reporting odds ratio model. Logistic regression revealed the duration of medication was the risk factor for tocilizumab, alendronate sodium, and erlotinib usage. Females were also identified as risk factor for erlotinib. CONCLUSIONS: Our study identified 32 drugs potentially inducing SU, which provides valuable insights for targeted prevention and treatment strategies aimed at mitigating the risk of drug-induced SU.
Potential risk analysis of antipsychotics-related constipation from the FDA Adverse Event Reporting System.
He S, Li C
Expert Opin Drug Saf · 2026 May · PMID 39962354 · Publisher ↗
BACKGROUND: Antipsychotics-related constipation is a frequently neglected and poorly researched adverse effects in patients in clinical practice. Constipation not only affects the physical health of patients but also inc...
BACKGROUND: Antipsychotics-related constipation is a frequently neglected and poorly researched adverse effects in patients in clinical practice. Constipation not only affects the physical health of patients but also increases the psychological stress to their disease burden, so it requires more attention. METHODS: We queried adverse event reports of antipsychotics-related constipation from the FDA Adverse Event Reporting System (FAERS) database between January 2017 and December 2022. The report odds ratio (ROR) and 95% confidence intervals (CIs) were calculated using case/non-case methods. RESULTS: A total of 562 constipation cases were attributed to atypical antipsychotics (AAPs) during the study period. Except for aripiprazole and ziprasidone, the values of the other drugs were all less than 0.05. The RORs values in descending order: amisulpride (ROR = 4.07), paliperidone (ROR = 2.73), quetiapine (ROR = 1.83), clozapine (ROR = 1.61), olanzapine (ROR = 1.50), risperidone (ROR = 0.71). CONCLUSION: This study found that clozapine, olanzapine, amisulpride, quetiapine, and paliperidone were correlated with constipation, while risperidone had the least effect on gastrointestinal function. Future analysis of the FAERS database in conjunction with other data sources will be essential for continuous monitoring of antipsychotics-related constipation.
Novel insights into post-marketing AEs associated with bempedoic acid: a comprehensive analysis utilizing the FAERS database.
Wang X, Liu Y, Han H … +6 more , Ma J, Tian N, Zhu R, Shi X, Jin J, Zhou H
Expert Opin Drug Saf · 2025 Feb · PMID 39960262 · Publisher ↗
BACKGROUND: Bempedoic acid is a new drug for lowering low-density lipoprotein cholesterol. This study used the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database to retrospec...
BACKGROUND: Bempedoic acid is a new drug for lowering low-density lipoprotein cholesterol. This study used the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database to retrospectively mine adverse events of oral bempedoic acid in the real world. RESEARCH DESIGN AND METHODS: The FAERS database was searched to extract the adverse reactions of bempedoic acid from the third quarter of 2020 to the fourth quarter of 2023. After data standardization, the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS) methods were used to comprehensively evaluate the adverse reaction signals. RESULTS: A total of 1091 adverse reaction reports were identified, and 70 adverse reaction terms were obtained, involving 22 system categories. According to the ROR signal ranking, the most affected System Organ Classes (SOCs) were "musculoskeletal and connective tissue disorders,""hepatobiliary disorders," and "investigation." Preferred Terms (PTs) with high signal intensity had low density lipoprotein abnormality, elevated blood uric acid, biliary colic, etc. New adverse reaction signals such as esophageal spasm, angina, apathy were reported. CONCLUSIONS: This study provide support for clinical monitoring and risk identification of bempedoic acid.
Hepatic adverse events with CDK4/6 inhibitors: a systematic review combining meta-analysis and FAERS database.
Tang Y, Li Y, Zhang C … +4 more , Ye Y, Qiu T, Zhu Z, Zhao J
Expert Opin Drug Saf · 2025 Feb · PMID 39960238 · Publisher ↗
BACKGROUND: Cell-cycle protein-dependent kinase 4 and 6 inhibitors (CDK4/6is) in combination with endocrine therapy (ET) are widely used in patients with early and advanced breast cancer (BC). CDK4/6is also lead to numer...
BACKGROUND: Cell-cycle protein-dependent kinase 4 and 6 inhibitors (CDK4/6is) in combination with endocrine therapy (ET) are widely used in patients with early and advanced breast cancer (BC). CDK4/6is also lead to numerous side effects. This study aims to elucidate the relationship between CDK4/6is and hepatotoxicities. RESEARCH DESIGN AND METHODS: As of 31 March 2024, we conducted a systematic search of PubMed, Embase, and the Cochrane Library databases, as well as several oncology conference proceedings. We included 20 randomized controlled trials (RCTs) with 24,342 breast cancer (BC) patients and 400 cases from the FDA Adverse Event Reporting System (FAERS). Fixed-effect and random-effect models were used to calculate odds ratios (ORs) of hepatotoxicity in the RCTs, while Reporting Odds Ratios (RORs) were calculated for the FAERS data. RESULTS: Overall, CDK4/6 inhibitors (CDK4/6is) were associated with significant hepatotoxicities compared to controls (OR = 1.76, 95%CI 1.40-2.22, I = 75%). Palbociclib, ribociclib, and abemaciclib exhibited significant hepatotoxicities, while dalpiciclib did not. FAERS data showed significant liver enzyme and organ toxicity signals for ribociclib and abemaciclib but not for palbociclib. CONCLUSIONS: CDK4/6is increase the risk of hepatotoxicities in patients with BC. Palbociclib, ribociclib, and abemaciclib caused liver damage, while dalpiciclib did not. The most common manifestations were elevated ALT and AST levels.
Toxicity spectrum of taxanes: a safety analysis from pre-marketing to post-marketing.
Zhao Q, Nian Z, He Y … +4 more , Lai L, Liu W, Huang S, Yang L
Expert Opin Drug Saf · 2026 Jun · PMID 39960060 · Publisher ↗
BACKGROUND: As fundamental chemotherapy drugs, paclitaxel and its derivatives are essential for cancer treatment. This analysis comprehensively evalutaed the toxicity spectrum of taxanes from the perspective of clinical...
BACKGROUND: As fundamental chemotherapy drugs, paclitaxel and its derivatives are essential for cancer treatment. This analysis comprehensively evalutaed the toxicity spectrum of taxanes from the perspective of clinical trials and the real-world. RESEARCH DESIGN AND METHODS: Pooled-analyses were performed to estimate incidences of adverse events (AEs) with random-effect models after searching databases. Reports of AEs were retrospectively obtained from the US Food and Drug Administration's (FDA's) Adverse Event Reporting System (FAERS) database, and positive signals were quantified by employing three algorithms. RESULTS: A total of 36 studies involving 10,828 patients were analyzed in pooled-analysis, and 58,835 case reports were retrieved. Leukopenia (59.69, 95% confidence interval 41.34-75.69) and neutropenia (29.69, 23.31-36.99) ranked first among all grades and severe AEs, respectively. Alopecia, regardless of grades, had the highest estimated incidence of non-hematological AEs. The estimated incidences of AEs of Nab-paclitaxel tended to be higher than other formulations, especially neutropenia (46.53, 35.01-58.42). Docetaxel had the least signals but alopecia and depression have quantified several signals. CONCLUSIONS: The safety of nab-paclitaxel was beyond expectation, and unusual signals of alopecia and depression of docetaxel need to be paid attention to. Results of clinical trials and FAERS indicated consistency between premarket and postmarket studies.
Biosimilars and immunogenicity: a matter of concern?
Jarab AS, Abu Heshmeh SR, Al Meslamani AZ
Expert Opin Drug Saf · 2025 May · PMID 39955621 · Publisher ↗
INTRODUCTION: Biosimilars have transformed treatment modalities across various medical fields such as oncology, rheumatology, and immunology. Despite their potential for reducing healthcare costs, concerns persist regard...
INTRODUCTION: Biosimilars have transformed treatment modalities across various medical fields such as oncology, rheumatology, and immunology. Despite their potential for reducing healthcare costs, concerns persist regarding their ability to induce an immune response, which could affect efficacy and safety. This review critically evaluates the current evidence on the immunogenicity of biosimilars and discusses the regulatory frameworks guiding their approval and monitoring. AREAS COVERED: This review includes studies from databases like Scopus, PubMed, Web of Science, and ScienceDirect, published up to April 2024. It explores the 'totality of the evidence' approach used by regulatory bodies like the FDA and EMA, detailing analytical, preclinical, and clinical assessments that ensure biosimilars' similarity to their reference products in terms of structure, function, and clinical outcomes. The review also addresses the challenges and limitations in current research methodologies and the implications of immunogenicity on therapeutic efficacy and patient safety. EXPERT OPINION: While substantial evidence confirms the safety and efficacy of biosimilars, the review emphasizes the need for continuous regulatory vigilance and advanced methodologies in post-marketing surveillance to capture long-term immunogenicity data effectively. It advocates for integrating cutting-edge analytical techniques and personalized medicine to better manage immunogenic risks associated with biological therapies.
Updated insights on levetiracetam-associated severe cutaneous adverse reactions: a real-world pharmacovigilance analysis.
Wu Z, Zhao Y, Zhang X … +1 more , Li Y
Expert Opin Drug Saf · 2026 Jun · PMID 39953850 · Publisher ↗
BACKGROUND: Previous studies have explored the association between levetiracetam (LEV) and severe cutaneous adverse reactions (SCARs). However, most investigations have relied on clinical trial data or case reports from...
BACKGROUND: Previous studies have explored the association between levetiracetam (LEV) and severe cutaneous adverse reactions (SCARs). However, most investigations have relied on clinical trial data or case reports from individual medical centers. Consequently, the precise relationship between LEV and SCARs in real-world settings remains elusive. RESEARCH DESIGN AND METHODS: Data from the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases were analyzed, focusing on LEV-associated SCAR events utilizing disproportionality analysis methods. RESULTS: This study identified a significant correlation between LEV and SCARs ( < 0.05). However, combined analyses with other antiepileptic drugs revealed that the association of LEV with SCARs was comparatively weaker ( < 0.05). Univariate logistic regression analysis indicated that males, individuals aged 45 ~ 65 years, and combination therapy with eslicarbazepine, phenytoin, carbamazepine, and lamotrigine significantly increased the risk of developing SCARs ( < 0.05). Notably, SCARs were most likely to occur within the initial week of LEV treatment (39.39%). CONCLUSIONS: Despite certain limitations, this study offers updated insights into the association between LEV and SCARs. These findings underscore the significance of monitoring and actively managing LEV-associated SCARs to promote its safe and effective use.
Impact of baseline glucocorticoids (GCs) on cardiotoxic events and myocardial damage related to immune checkpoint inhibitors: a retrospective clinical research.
Wang Q, Zhang H, Chen Y … +3 more , Lv X, Qiao Y, Zhu Q
Expert Opin Drug Saf · 2025 Feb · PMID 39953683 · Publisher ↗
BACKGROUND: Immune checkpoint inhibitors (ICIs)-associated cardiotoxic events (CEs) are of increasing concern. Existing research about glucocorticoids (GCs) on immunotherapy focused on ICIs' efficacy and patients' outcom...
BACKGROUND: Immune checkpoint inhibitors (ICIs)-associated cardiotoxic events (CEs) are of increasing concern. Existing research about glucocorticoids (GCs) on immunotherapy focused on ICIs' efficacy and patients' outcome. The influence of GCs on ICIs-associated CEs and myocardial damage (MD) remains unknown. RESEARCH DESIGN AND METHODS: This single-center retrospective study included patients treated with ICIs from 2018 to 2022, with follow-up period ending on 30 June 2023. The incidence, risk factors of ICIs-associated CEs, especially MD were described. Additionally, the impact of baseline GCs was assessed by propensity score matching (PSM) to mitigate intergroup differences and ensure comparability. RESULTS: Among 1018 patients, 204 (20.04%) experienced ICIs-associated CEs, including 71 (6.97%) with MD. The mean follow-up time was 40.39 (95% CI 38.47-42.31) weeks. The median time to onset of MD was the shortest at 12.57 weeks (IQR 5.29-25.14). Tumor type, co-medication with platinum and angiogenesis inhibitors may be influential factors of MD. After PSM, the relative risks of CEs (OR 0.4625,95%CI 0.2514-0.7235, = 0.0020) and MD (OR 0.3254, 95% CI 0.1190-0.8898, = 0.0378) in GCs1 ≥ 20 mg group were both significantly lower than those in GCs1 < 20 mg. CONCLUSION: GCs ≥ 20 mg during the first ICIs treatment cycle is significantly associated with the reduced risks of both ICIs-associated CEs and MD.
Safety issues of Donepezil combined with Memantine in Alzheimer's disease population: real-world pharmacovigilance.
Zeng Y, Liu B, Zhou L … +4 more , Zeng W, Tian X, Jiang J, Dai D
Expert Opin Drug Saf · 2025 Feb · PMID 39950934 · Publisher ↗
BACKGROUND: Alzheimer's disease (AD) is the most common form of dementia. The combination of Donepezil and Memantine is the only FDA-approved therapy for AD, but its adverse drug reactions (ADRs) lack systematic analysis...
BACKGROUND: Alzheimer's disease (AD) is the most common form of dementia. The combination of Donepezil and Memantine is the only FDA-approved therapy for AD, but its adverse drug reactions (ADRs) lack systematic analysis. This study carried out drug combination analysis for AD population to provide evidence support for clinical safety of drug use. RESEARCH DESIGN AND METHODS: Using FAERS database reports (January 2004-January 2024) with Donepezil and Memantine as primary suspected drugs, four disproportionality analysis methods - ROR, PRR, BCPNN, and EBGM - were applied to identify positive ADR signals. Subgroup analyses were conducted by age and gender. RESULTS: A total of 712 reports were analyzed (54.6% female, 55.1% aged 65-85). Across the AD population, 42 ADRs were identified, including hypertensive crisis, hyperglycemia, hyperosmolar nonketotic syndrome, proteinuria, and hydronephrosis, many of which were newly reported. Subgroup analysis revealed prostate hypertrophy, acute kidney injury, and cerebral infarction in males, while females experienced more severe cardiovascular events, such as complete AV block and ventricular extrasystole. Additional ADRs included hyperkalemia, sinus bradycardia, and extrapyramidal disorders. CONCLUSIONS: Despite partial consistency of combined ADRs for Donepezil and Memantine with instructions, new ADR signals emerged, with significant differences in AD subgroups.
Post-marketing safety assessment of constipation drugs: a real-world pharmacovigilance study based on FAERS database.
Zhang W, Wang H, Yang S … +4 more , Pang X, Hu W, Zhang G, Xin X
Expert Opin Drug Saf · 2026 Jul · PMID 39950440 · Publisher ↗
BACKGROUND: Laxatives are widely used in the treatment of constipation, but they also have brought many adverse reactions to patients. METHODS: We conducted a pharmacovigilance analysis based on the United States Food an...
BACKGROUND: Laxatives are widely used in the treatment of constipation, but they also have brought many adverse reactions to patients. METHODS: We conducted a pharmacovigilance analysis based on the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database to analyze the adverse events of six constipation drugs (linaclotide, lubiprostone, prucalopride, naloxegol, naldemedine, and plecanatide) and to search for clinically meaningful adverse reaction signals. We used disproportionality analysis as the main analysis method to detect pharmacovigilance signals, which includes Frequentist methods and Bayesian methods. RESULTS: Among the reports of the six drugs, more adverse reactions were reported from females than males, and the number of adverse reactions reported was higher in the group of 60-89 years. Linaclotide had the lowest proportion of serious adverse event reports (4.38%), while naldemedine had the highest proportion of serious adverse event reports (25.57%). According to the classification of system organ classification (SOC), the number of gastrointestinal adverse events ( = 8321) was the largest. CONCLUSIONS: The adverse reactions of constipation drugs were mainly gastrointestinal symptoms such as diarrhea, abdominal pain and abdominal distension. Linaclotide has the highest safety, and more studies are needed to analyze the cardiovascular safety of lubiprostone.
Hepatic adverse events associated with anaplastic lymphoma kinase tyrosine kinase inhibitors: a disproportionality analysis based on FAERS database and analysis of drug-gene interaction network.
Huo Y, Ma M, Tian W … +2 more , Wang F, Liao X
Expert Opin Drug Saf · 2025 Feb · PMID 39949054 · Publisher ↗
BACKGROUND: Anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs) are vital for treating ALK-positive cancers but have been associated with liver injury, necessitating further safety investigation. This stud...
BACKGROUND: Anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs) are vital for treating ALK-positive cancers but have been associated with liver injury, necessitating further safety investigation. This study examines hepatic adverse event (AE) signals related to ALK TKIs using the U.S. FDA Adverse Event Reporting System (FAERS) and explores potential mechanisms of liver injury. RESEARCH DESIGN AND METHODS: AE reports from FAERS (Q3 2011 to Q1 2024) related to liver injury were analyzed using the reporting odds ratio (ROR) and multi-item gamma Poisson shrinker (MGPS) methods. Pathway enrichment and drug-gene network analyses were performed to investigate underlying mechanisms. RESULTS: This study identified 2,132 AE reports from the FAERS database linking hepatic AEs to ALK TKIs therapy. Significant signals were detected by ROR and MGPS methods, with common AEs including aminotransferase abnormalities, hyperbilirubinemia, and increased blood alkaline phosphatase, mainly occurring within the first 30 days of treatment. Gene analysis revealed key nodes in the protein-protein interaction (PPI) network, such as PIK3CA, SRC, and PTK2. Enriched KEGG pathways included the MAPK, PI3K-Akt, and Ras signaling. CONCLUSION: This pharmacovigilance study identifies significant AE signals linking ALK TKIs to liver injury, highlighting potential mechanisms and providing insights for clinical management and patient outcomes.
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