Expert Opinion On Drug Safety[JOURNAL]
Sun
200 papers
Identifying signals of disproportionate reporting for calcitonin gene-related peptide inhibitors: real-world evidence from the FDA adverse event reporting system.
Lee N, Ok J, Kwon Y … +2 more , Rhee SJ, Kim Y
Expert Opin Drug Saf · 2025 Apr · PMID 40261259 · Publisher ↗
BACKGROUND: Calcitonin gene-related peptide (CGRP) inhibitors have been FDA-approved for migraine prophylaxis and relief. However, their safety profile remains uncertain. This study analyzes adverse events (AEs) and sign...
BACKGROUND: Calcitonin gene-related peptide (CGRP) inhibitors have been FDA-approved for migraine prophylaxis and relief. However, their safety profile remains uncertain. This study analyzes adverse events (AEs) and signals of disproportionate reporting (SDRs) using the FDA Adverse Event Reporting System (FAERS). RESEARCH DESIGN AND METHODS: We analyzed FAERS reports from approval through Q2 2023, standardizing terms using preferred terminology and system organ class (SOCs) classifications. Disproportionality analyses (ROR, PRR, IC) identified SDRs and inclusion in FDA prescribing information was reviewed. Additional analyses included comparisons with other migraine drugs, indication-based sensitivity analyses and causality assessment using the Bradford Hill framework. RESULTS: Galcanezumab showed strong signals for underdose (ROR 47.4; 95% CI 43.79-51.3), alopecia (5.72; 5.09-6.43), and constipation (6.01; 5.35-6.75), while fremanezumab exhibited notable associations with alopecia (6.9; 5.72-8.33) and weight increased (6.34; 5.18-7.76). Among gepants, rimegepant was linked to somnolence (4.52; 3.57-5.73) and dizziness (3.73; 3.15-4.42) and atogepant showed a strong signal for therapy interruption (16.58; 12.86-21.38). CONCLUSIONS: This study highlights CGRP inhibitor-associated AEs, underscoring the need for clinical monitoring and risk identification. Early detection of AEs and SDRs can inform protective measures to enhance patient safety.
Pre- and post-operative safety considerations for patients undergoing percutaneous nephrolithotomy.
Coman RA, Tzelves L, Juliebø-Jones P … +5 more , Talyshinskii A, Nedbal C, Ventimiglia E, Davis N, Somani BK
Expert Opin Drug Saf · 2025 Dec · PMID 40254899 · Publisher ↗
INTRODUCTION: Percutaneous nephrolithotomy (PCNL) is a widely used surgical procedure for treating large and complex kidney stones. Although effective, it carries risks of complications such as bleeding, infection, and i...
INTRODUCTION: Percutaneous nephrolithotomy (PCNL) is a widely used surgical procedure for treating large and complex kidney stones. Although effective, it carries risks of complications such as bleeding, infection, and injury to adjacent structures. Optimization of procedural techniques and perioperative care can help minimize these risks. AREAS COVERED: This review examines key pre- and post-operative safety considerations for PCNL patients. Topics include pre-operative imaging, patient positioning, puncture techniques, tract dilation, postoperative drainage, and complication management. The literature search involved analyzing recent studies and clinical guidelines to identify best practices. The search was conducted in several databases, including PubMed, Embase, the Cochrane Library and clinical guidelines. Training modalities for improving procedural skills are discussed. EXPERT OPINION: Improving the safety of PCNL requires a combination of meticulous surgical technique, proper patient selection, and adherence to standardized protocols. Continuous skill development and technological advancements will further improve patient outcomes.
Management of refractory checkpoint inhibitor-induced colitis.
Zaher A, Moura Nascimento Santos MJ, Elsaygh H … +4 more , Peterson SJ, Colli Cruz C, Thomas AS, Wang Y
Expert Opin Drug Saf · 2026 Jan · PMID 40251944 · Publisher ↗
INTRODUCTION: This review discusses the epidemiology, pathophysiology, and factors associated with refractory immune-mediated diarrhea and colitis (r-IMDC), emphasizing tailored treatment strategies. AREAS COVERED: The c...
INTRODUCTION: This review discusses the epidemiology, pathophysiology, and factors associated with refractory immune-mediated diarrhea and colitis (r-IMDC), emphasizing tailored treatment strategies. AREAS COVERED: The current literature on r-IMDC was reviewed using PubMed (2015-2025), focusing on clinical trials, meta-analyses, and case reports relevant to its management. EXPERT OPINION: Effectively managing r-IMDC is crucial for balancing toxicities and antitumor response. Available second and third-line management options for r-IMDC cases must be carefully evaluated. Future perspectives include development of standardized protocols beyond second-line therapies and predictive biomarkers to enable personalized treatment.
Attention to the interactions between vincristine and triazole antifungals: perspectives from real-world retrospective analysis and pharmacovigilance assessment.
Huang D, Zhang Y, Liu L … +3 more , Yang M, Zeng T, Wang S
Expert Opin Drug Saf · 2025 Apr · PMID 40249035 · Publisher ↗
BACKGROUND: In patients with hematologic malignancies, the combination of triazole antifungals and vincristine can lead to severe neurological toxicity. We attempted to assess the adverse events (AEs) associated with the...
BACKGROUND: In patients with hematologic malignancies, the combination of triazole antifungals and vincristine can lead to severe neurological toxicity. We attempted to assess the adverse events (AEs) associated with these interactions, particularly ileus. RESEARCH DESIGN AND METHODS: We retrieved AEs data from FAERS database (2004-2023) focusing on the combination of four triazoles (fluconazole, itraconazole, voriconazole, posaconazole) with vincristine. Case reports of AEs were collected for retrospective analysis up to 31 December 2023. RESULTS: The FAERS database indicated that neurological and gastrointestinal systems were most commonly involved systems when combined use triazole antifungals and vincristine, with ileus being the most frequently reported AE. The highest signal strengths for ileus were with itraconazole. AEs associated with concomitant use of triazole antifungal drugs and vincristine were identified through retrospective analysis of 42 clinical case reports, of which itraconazole, posaconazole, and voriconazole were involved in 66.7%, 28.6%, and 4.8% of cases, respectively. Patients who received the two-drug combination experienced AEs within one month in 88.1% of cases. Almost all patients improved within one month after discontinuing or switching antifungal drugs. CONCLUSIONS: Ileus is the most common AE associated with the combination of triazole antifungals and vincristine, with itraconazole showing the highest risk.
Thromboembolic and bleeding events associated with angiogenesis inhibitors in cancer patients.
Ma Z, Zhang Y, Sun D … +5 more , Zhu M, Yi J, Zhang Y, An Z, Zhang Y
Expert Opin Drug Saf · 2025 May · PMID 40246589 · Publisher ↗
BACKGROUND: Angiogenesis inhibitors are associated with increased risk of thromboembolic events (TEEs) and hemorrhagic events. However, their clinical features are not well characterized in real-world studies. RESEARCH D...
BACKGROUND: Angiogenesis inhibitors are associated with increased risk of thromboembolic events (TEEs) and hemorrhagic events. However, their clinical features are not well characterized in real-world studies. RESEARCH DESIGN AND METHODS: First, we conducted a pharmacovigilance study to investigate characteristics of TEEs and bleeding and compare vascular endothelial growth factor and its receptor inhibitors (VEGF/VEGFRIs) with other antiangiogenic agents. Second, we performed a retrospective analysis of lung cancer patients who received bevacizumab or anlotinib to assess the incidence of VEGF/VEGFRI-associated TEEs and bleeding. RESULTS: In the pharmacovigilance study, both VEGF/VEGFR-targeted biologics and VEGFR-tyrosine kinase inhibitors were associated with higher reporting of arterial thromboembolism (ATE) (reporting odd ratio (ROR) 2.91; ROR 1.25; respectively), and bleeding (ROR 2.56; ROR 2.35; respectively). Venous thromboembolism (VTE) was only associated with VEGF/VEGFR-targeted biologics (ROR 3.11). In the cohort study, bevacizumab, aflibercept, and ramucirumab showed the strongest associations with VTE, ATE, and bleeding, respectively. In the cohort study of 261 lung cancer patients treated with bevacizumab or anlotinib, 42.9% were older than 65 years, 62.1% were male, with TEEs occurred in 11.5%, and bleeding in 8.8%. CONCLUSIONS: All VEGF/VEGFRIs were associated with increased ATE and bleeding risk. VEGF/VEGFR-targeted biologics also significantly raise the risk of VTE.
Comparative safety analysis of baloxavir marboxil and oseltamivir based on the FAERS database.
Tu Y, Lai X, Wan Q … +1 more , Xu T
Expert Opin Drug Saf · 2026 Feb · PMID 40244175 · Publisher ↗
BACKGROUND: This study aimed to analyze adverse drug events (ADEs) of oseltamivir or baloxavir marboxil monotherapy using the Food and Drug Administration Adverse Event Reporting System (FAERS) database, providing a valu...
BACKGROUND: This study aimed to analyze adverse drug events (ADEs) of oseltamivir or baloxavir marboxil monotherapy using the Food and Drug Administration Adverse Event Reporting System (FAERS) database, providing a valuable reference for clinical drug safety. RESEARCH DESIGN AND METHODS: FAERS data for oseltamivir and baloxavir marboxil from their market approval in the United States until the third quarter of 2023 were retrieved. Signal detection was performed using the reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods. ADEs were classified according to the System Organ Class (SOC) in the Medical Dictionary for Regulatory Activities (MedDRA) version 25.0. RESULTS: A total of 1,727 and 12,607 ADE reports were retrieved for baloxavir marboxil and oseltamivir, respectively, involving 17 and 26 SOC categories. Baloxavir marboxil demonstrated a strong association with ischemic colitis, melena, delirium febrile, enterocolitis, febrile convulsion, and altered state of consciousness. Oseltamivir exhibited a strong association with pathological personality, thinking abnormal, agitation, abnormal behavior, somnambulism, delirium febrile, and spinal cord hemorrhage. CONCLUSIONS: When using oseltamivir and baloxavir marboxil clinically, attention should be paid not only to common ADEs but also to those not mentioned on the drug label.
Infection-related adverse events comparison of bortezomib, carfilzomib and ixazomib: a pharmacovigilance study based on FAERS.
Xiang C, Guo R, Ti J … +2 more , Zhang S, Wang T
Expert Opin Drug Saf · 2025 Apr · PMID 40243068 · Publisher ↗
BACKGROUND: Bortezomib, carfilzomib and ixazomib are the most common proteasome inhibitors (PIs) used to treat Multiple Myeloma (MM). We conducted a pharmacovigilance analysis using the Food and Drug Administration Adver...
BACKGROUND: Bortezomib, carfilzomib and ixazomib are the most common proteasome inhibitors (PIs) used to treat Multiple Myeloma (MM). We conducted a pharmacovigilance analysis using the Food and Drug Administration Adverse Event Reporting System (FAERS), aiming to offer a reference for safe and reasonable clinical use. RESEARCH DESIGN AND METHODS: Adverse drug reaction (ADR) signals of bortezomib, carfilzomib and ixazomib were analyzed by statistical methods including Reporting Odds Ratio (ROR), Proportional Reporting Ratios (PRR), and Multi-item Gamma-Poisson Shrinker (MGPS). RESULTS: A total of 13,977, 8263 and 13296 ADRs of bortezomib, carfilzomib and ixazomib were analyzed respectively from the FAERS database. The most frequent adverse reaction signal for bortezomib was peripheral neuropathy; for carfilzomib, it was acute kidney injury; for ixazomib, it was vomiting. Then, a total of 43, 23 and 10 infection-related adverse events of bortezomib, carfilzomib and ixazomib were analyzed. The most common infection-related adverse event for bortezomib was cytomegalovirus infection; for carfilzomib, it was bacteremia; and for ixazomib, it was conjunctivitis. CONCLUSIONS: In real-world pharmacovigilance studies, PIs are associated with infection-related adverse events, which is crucial for the safe use of PIs in the treatment of MM. However, further research is needed to validate the hypotheses generated in this study.
Hepatobiliary disorders and Direct-Acting Antiviral (DAA) therapies: real-world evidence and insights from the EudraVigilance database.
Scicluna J, Di Napoli R, Pirozzi D … +4 more , Fraenza F, Cardillo M, Scavone C, Capuano A
Expert Opin Drug Saf · 2025 Apr · PMID 40243008 · Publisher ↗
BACKGROUND: The introduction of Direct-Acting Antivirals (DAA) brought about a breakthrough in the treatment of HCV. This study aims to analyze the hepatic safety profile of Harvoni® (sofosbuvir/ledipasvir), Epclusa® (so...
BACKGROUND: The introduction of Direct-Acting Antivirals (DAA) brought about a breakthrough in the treatment of HCV. This study aims to analyze the hepatic safety profile of Harvoni® (sofosbuvir/ledipasvir), Epclusa® (sofosbuvir/velpatasvir), and Vosevi® (sofosbuvir/velpatasvir/voxilaprevir) through a review of the Individual Case Safety Reports (ICSRs) reported in EudraVigilance (EV). RESEARCH DESIGN AND METHODS: ICSRs with adverse events (AE) belonging to the system organ class (SOC) hepatobiliary disorders were retrieved from the EV database. A descriptive analysis was performed. Reporting odds ratios (ROR) were calculated to assess the reporting frequency of hepatobiliary disorders among the DAA combinations. RESULTS: Out of 5,552 ICSRs reported between January 2018 and December 2023, 1,942 were for Harvoni®, 3,180 for Epclusa® and 430 for Vosevi®. Three hundred and thirty-nine ICSRs reported 1,616 PT within the SOC hepatobiliary disorders. Harvoni® showed a statistically significant lower frequency of reporting for the hepatobiliary disorders SOC when compared to Epclusa® and Vosevi® (ROR, 0.33; 95% CI [0.26-0.41] and ROR 0.31; 95% CI [0.19-0.48], respectively). CONCLUSION: Harvoni® showed a lower reporting frequency of hepatobiliary disorders and fewer drug ineffectiveness reports, suggesting it may be preferred over Epclusa® and Vosevi® in patients with preexisting liver or biliary conditions.
Hypogammaglobulinemia in patients with multiple sclerosis receiving disease modifying therapies: disproportionality analysis using the EudraVigilance database.
Di Napoli R, Balzano N, Rafaniello C … +6 more , Della Monica P, Di Domenico M, Di Giulio Cesare D, Maniscalco GT, Scavone C, Trama U
Expert Opin Drug Saf · 2025 Apr · PMID 40235349 · Publisher ↗
BACKGROUND: Monoclonal antibodies targeting CD20, such as rituximab, ocrelizumab, and ofatumumab, are crucial in managing multiple sclerosis (MS). However, they can cause hypogammaglobulinemia, increasing the risk of inf...
BACKGROUND: Monoclonal antibodies targeting CD20, such as rituximab, ocrelizumab, and ofatumumab, are crucial in managing multiple sclerosis (MS). However, they can cause hypogammaglobulinemia, increasing the risk of infections and autoimmune disorders. RESEARCH DESIGN AND METHODS: This study describes cases of hypogammaglobulinemia in MS patients receiving anti-CD20 monoclonal antibodies, using data from the European spontaneous reporting system database, EudraVigilance. RESULTS: A total of 135 individual case safety reports (ICSRs), covering 469 adverse drug reactions (ADRs), were retrieved. The majority of ICSRs were related to ocrelizumab ( = 93) and involved cases of hypogammaglobulinemia occurring in adult females. Almost 20% of ICSRs reported concomitant medications, mainly represented by antibiotics, vitamins and antiepileptics. Among the 469 ADRs, 36.8% were serious, and 66% had an unknown outcome. The most commonly reported ADRs belonged to the SOC 'Infections and infestations' and included cases of COVID-19 and respiratory tract infection. Lastly, disproportionality analysis did not show a statistically significant probability of gamma globulin reduction comparing each drug. CONCLUSIONS: The study highlights the importance of monitoring for the occurrence of hypogammaglobulinemia and infections in patients receiving ocrelizumab, ofatumumab and rituximab for MS. These ADRs can be extremely serious and highlight the need for ongoing research to optimize their safety profiles.
Retrospective analysis of clinical features of liver injury induced by levofloxacin.
Wu Z, Sun W, Wang C
Expert Opin Drug Saf · 2025 Apr · PMID 40232390 · Publisher ↗
BACKGROUND: Current understanding of the relationship between levofloxacin exposure and hepatic injury primarily relies on case reports. This article aims to investigate the features of levofloxacin-induced liver injury....
BACKGROUND: Current understanding of the relationship between levofloxacin exposure and hepatic injury primarily relies on case reports. This article aims to investigate the features of levofloxacin-induced liver injury. RESEARCH DESIGN AND METHODS: We incorporated case series and reports regarding levofloxacin-induced hepatotoxicity published prior to 30 June 2024, utilizing an extensive search database. The data from 40 patients were collected and subjected to descriptive analysis. RESULTS: The median age of the 40 patients was 60 years (range 10, 99), and the median time to exacerbation was 5 days (range 1 199). Liver injury was categorized as hepatocellular (62.5%), cholestatic (12.5%), and mixed (25.0%). Clinical manifestations included asymptomatic elevations in liver enzymes, jaundice, dark urine, nausea, vomiting, anorexia, hepatic encephalopathy. Laboratory evaluations revealed varying degrees of elevation in aminotransferases and total bilirubin. Biopsy results indicated hepatic necrosis, cholestasis, steatosis, and inflammatory infiltrates. After levofloxacin discontinuation, the median time to normalization of liver function was 21 days (range 3, 103), and 8 patients ultimately succumbing to the condition. CONCLUSIONS: Hepatotoxicity is an uncommon but severe adverse effect associated with levofloxacin. Immediate discontinuation of levofloxacin is warranted if there is a rapid increase in aminotransferase levels or the emergence of hepatitis symptoms.
Adverse events of concomitant use of immune checkpoint inhibitors and metformin or statin: an observational, retrospective disproportionality analysis.
Li W, Wang W
Expert Opin Drug Saf · 2025 Apr · PMID 40232293 · Publisher ↗
BACKGROUND: Preclinical investigations have indicated that the concurrent administration of ICIs with statins or metformin may enhance the anticancer properties. Nevertheless, the patterns of potential toxicity associate...
BACKGROUND: Preclinical investigations have indicated that the concurrent administration of ICIs with statins or metformin may enhance the anticancer properties. Nevertheless, the patterns of potential toxicity associated with this combination have yet to be elucidated. RESEARCH DESIGN AND METHODS: We utilized the Food and Drug Administration Adverse Event Reporting System (FAERS) to provide an overview of the adverse event landscape tied to the concomitant utilization of ICI and statins or metformin. RESULTS: Our study reveals significant side effects associated with combining ICIs with metformin or statins, including gastrointestinal, respiratory, hepatobiliary, and renal disorders. Amalgamated treatment of ICIs plus metformin may heighten the likelihood of bone marrow aplasia, inflammatory bowel disease, intestinal perforation, hepatic impairments, insomnia, autoimmune nephritis, and eczematous manifestations. For ICIs plus statins, colitis, pneumonitis, interstitial lung disease, hypothyroidism, adrenal insufficiency, myocarditis, myositis, hypophysitis, myasthenia gravis, and hepatitis. Importantly, a significant number of adverse events occur within the first two months of starting ICIs alongside metformin or statins, with some appearing after a year of treatment, emphasizing the need for ongoing monitoring. CONCLUSION: The observations delineated offer pivotal insights into the refinement of the co-administration strategy for ICIs with metformin or statins, attenuating the incidence of adverse side effects.
A disproportionality analysis of interstitial lung disease associated with drug therapy in spontaneous adverse event reports.
Yuan J, Li Z, Ye M … +1 more , Fu Z
Expert Opin Drug Saf · 2025 Apr · PMID 40232264 · Publisher ↗
BACKGROUND: Interstitial lung disease (ILD) is a group of disorders characterized by inflammation and fibrosis of lung tissue that make it hard to carry oxygen. Our study aimed to comprehensively evaluate the risk of dru...
BACKGROUND: Interstitial lung disease (ILD) is a group of disorders characterized by inflammation and fibrosis of lung tissue that make it hard to carry oxygen. Our study aimed to comprehensively evaluate the risk of drug-induced ILD using data from the FDA Adverse Event Reporting System (FAERS) database. RESEARCH DESIGN AND METHODS: We queried the ILD reports from 2004 to 2023. The reporting odds ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) were calculated to detect disproportionality signals for drugs associated with ILD. RESULTS: A total of 39,332 ILD-related reports were identified. The most frequently reported drugs were Methotrexate ( = 1245), followed by Pembrolizumab ( = 1026), Amiodarone ( = 975), Rituximab ( = 915), and Doxorubicin ( = 911). Disproportionality analysis revealed significant signals for the top 50 drugs, including Trastuzumab deruxtecan (ROR 56.25, 95% CI 51.27-61.72; IC025 5.49), Ramucirumab (ROR 27.80, 95% CI 241.6-31.99; IC025 4.50), Amiodarone (ROR 24.35, 95% CI 22.82-25.99; IC025 4.40), Gefitinib (ROR 23.02, 95% CI 20.66-25.66; IC025 4.29), and Doxorubicin (ROR 13.99, 95% CI 13.09-14.95; IC025 3.64). CONCLUSIONS: Drug-induced ILD represents a significant challenge in clinical practice. Our findings underscore the importance of maintaining a high index of suspicion for drug-induced ILD, particularly when prescribing medications identified as having significant associations with ILD.
Pancreatic adverse events induced by immune checkpoint inhibitors: a real-world observational study.
Zhan M, Long Q, He J … +4 more , Huang L, Liu R, Wu B, Xu T
Expert Opin Drug Saf · 2025 Apr · PMID 40227866 · Publisher ↗
BACKGROUND: Immune checkpoint inhibitor (ICI)-induced pancreatic adverse events (AEs) are rare occurrences that are poorly documented in the literature. RESEARCH DESIGN AND METHODS: We conducted a retrospective review of...
BACKGROUND: Immune checkpoint inhibitor (ICI)-induced pancreatic adverse events (AEs) are rare occurrences that are poorly documented in the literature. RESEARCH DESIGN AND METHODS: We conducted a retrospective review of patients who had ICI up to June 2023. Patient follow-up was extended until death or to May 2024. The primary outcome was the incidence of severe ICI-related pancreatic AEs. Logistic regression was used to investigate the associations between clinical characteristics and severe ICI-related pancreatic AEs. RESULTS: The study included 7,840 participants who received ICI. The study population was predominantly male (74.50%), with a median age of 59.20 years [IQR 51.90-67.70 years]. Among them, 49 patients (0.63%) developed severe ICI-related pancreatic AEs. Logistic regression revealed that pancreatic cancer (OR 5.47; [95% CI, 1.12-26.82], = 0.036), lung cancer (OR 2.62; [95% CI, 1.09-6.34], = 0.032), younger patients (OR 0.97; [95% CI, 0.94-0.99], = 0.015), and using PD-L1 inhibitor (OR 3.09, [95% CI 1.46 to 6.52], = 0.003) were associated with a higher risk of severe ICI-related pancreatic AEs. CONCLUSIONS: This study demonstrated that most ICI-related pancreatic AEs were asymptomatic. Primary tumor type, age, and ICI type may be predictive factors for severe ICI-related pancreatic AEs. CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn identifier is ChiCTR2300075974.
A real-world pharmacovigilance study and pharmacological analysis of sulfasalazine based on the FDA adverse event reporting system (FAERS) database.
Guo D, Tang B, Luo P … +9 more , Zhang J, Deng L, Fu S, Shen Z, Li Q, Xie Z, Hang N, Fan H, Wang L
Expert Opin Drug Saf · 2025 May · PMID 40222949 · Publisher ↗
OBJECTIVE: The purpose of this study was to use the FDA Adverse Event Reporting System (FAERS) to detect and identify adverse events (AEs) related to sulfasalazine to provide a reference for clinical use. METHODS: Four a...
OBJECTIVE: The purpose of this study was to use the FDA Adverse Event Reporting System (FAERS) to detect and identify adverse events (AEs) related to sulfasalazine to provide a reference for clinical use. METHODS: Four algorithms (ROR, PRR, BCPNN and EBGM) were used to detect sulfasalazine-correlated AE signals in real data to calculate the signals associated with sulfasalazine-related AEs. RESULTS: During the study period, FAERS was used to extract a total of 91,509 sulfasalazine-related (SASP-related) adverse event reports. In total, 6830 sulfasalazine adverse event signals were found, involving 23 organ systems. The analysis revealed several common adverse reactions; the most common were dizziness, malaise, asthenia, decreased appetite, rash, and anemia, and these adverse reactions are listed on the warning label for sulfasalazine. It is worth noting that in our study, in the preferred term (PT), we also found some reactions that were not mentioned on the warning label, such as blurred vision and cardiac failure. CONCLUSION: This study revealed potential new AEs resulting from sulfasalazine, and further studies are needed to confirm these new AEs.
Drug-induced Guillain-Barré Syndrome: a disproportionality analysis based on the US FDA adverse event reporting system.
Zhong R, Li J, Zhang F … +1 more , Guo Y
Expert Opin Drug Saf · 2025 Apr · PMID 40220275 · Publisher ↗
BACKGROUND: Guillain-Barré Syndrome (GBS) is a rare but severe neurological disorder often precipitated by infections, vaccines, and potentially by certain medications. Drug-induced GBS, though less commonly reported, pr...
BACKGROUND: Guillain-Barré Syndrome (GBS) is a rare but severe neurological disorder often precipitated by infections, vaccines, and potentially by certain medications. Drug-induced GBS, though less commonly reported, presents significant diagnostic and therapeutic challenges. This study investigates the correlation between various medications and the onset of GBS. RESEARCH DESIGN AND METHODS: We conducted a retrospective pharmacovigilance analysis using data from the FDA Adverse Event Reporting System (FAERS) from Q1 2004 to Q1 2024. The analysis focused on identifying drugs frequently associated with GBS and examining the time-to-onset and severity of these events. RESULTS: From over 17 million adverse events, 1,869 cases were identified as drug-induced GBS. Monoclonal antibodies and immunomodulators were the most frequently implicated drug classes. The median time-to-onset for GBS was within the first 30 days following drug exposure. Approximately 51.8% of the cases resulted in severe outcomes, such as hospitalization or disability. Drugs such as brentuximab vedotin and efalizumab showed strong associations with GBS occurrences. CONCLUSIONS: This study highlights the importance of monitoring for GBS symptoms following the administration of certain medications, particularly those that affect immune function, and underscores the need for healthcare providers to be aware of the potential neurological risks associated with these medications.
Does the use of generative AI chatbots by patients introduce risk of adverse drug events?
McIntyre RS
Expert Opin Drug Saf · 2025 Nov · PMID 40220270 · Publisher ↗
Abstract loading — click title to view on PubMed.
Comprehensive analysis of adverse drug reactions associated with teduglutide: post-marketing insights and safety implications.
Kudaravalli P, Andrews MB, Adler DG
Expert Opin Drug Saf · 2025 Apr · PMID 40219687 · Publisher ↗
BACKGROUND: Intestinal failure often necessitates teduglutide, a glucagon-like peptide-2 (GLP-2) analog that enhances intestinal adaptation by increasing absorptive surface area, thereby reducing reliance on intravenous...
BACKGROUND: Intestinal failure often necessitates teduglutide, a glucagon-like peptide-2 (GLP-2) analog that enhances intestinal adaptation by increasing absorptive surface area, thereby reducing reliance on intravenous supplementation (IVS). This study analyzes adverse drug reactions (ADRs) associated with teduglutide when used to treat short bowel syndrome (SBS) to inform clinical practice and enhance post-marketing surveillance. RESEARCH DESIGN AND METHODS: Retrospective analysis was conducted using the FDA Adverse Event Reporting System (FAERS) database. ADRs reported from teduglutide's FDA approval in 2012 through 20 August 2024 were analyzed using descriptive statistics and presented as [N (%)] or [median (IQR)]. RESULTS: Of the 4,533 reports, 2,669 were females, and patients had a median age of 56 years, with 2,787 reports involving hospitalization and 443 associated with death. Gastrointestinal ADRs were the most frequently reported ( = 3,881), followed by infections ( = 2,273), cardiovascular events ( = 1,318), weight changes ( = 754), neuropsychiatric concerns ( = 651), and device-related infections ( = 618) were prominent. Mortality associated ADRs included infections ( = 222), gastrointestinal events ( = 172), and cardiovascular complications ( = 132). CONCLUSIONS: Teduglutide is associated with significant ADRs necessitating vigilant monitoring while managing SBS patients, particularly for gastrointestinal health and infection risks. FAERS data limitations restrict causality determination, highlighting the need for further research to optimize safety.
A real-world pharmacovigilance case/non-case study of FDA adverse event reporting system events for mannitol.
Jin Z, Liu Y, Zhao Z
Expert Opin Drug Saf · 2025 Apr · PMID 40210584 · Publisher ↗
BACKGROUND: Mannitol, an osmotic diuretic, is widely used to treat edema, intracranial hypertension, and cerebral edema. This study analyzed mannitol-related adverse events (AEs) using the FDA adverse event reporting sys...
BACKGROUND: Mannitol, an osmotic diuretic, is widely used to treat edema, intracranial hypertension, and cerebral edema. This study analyzed mannitol-related adverse events (AEs) using the FDA adverse event reporting system (FAERS) data to identify potential safety signals. RESEARCH DESIGN AND METHODS: A retrospective pharmacovigilance study was conducted using FAERS data from Q1 2013 to Q4 2023. Signal detection algorithms, including the reporting odds ratio (ROR) and proportional reporting ratio (PRR), were employed to identify and evaluate mannitol-related AEs. The analysis focused on the frequency, severity, and clinical relevance of reported AEs. RESULTS: Among 39,061,894 reports, 1,014 mentioned mannitol. Common AEs included increased intracranial pressure, hyperosmolar state, hyperchloremia, and hypernatremia. 80% of AEs fell under 'renal and urinary disorders' (295 cases), 'skin and subcutaneous tissue disorders' (371 cases). Specific preferred terms (PTs) linked with mannitol included 'hyperosmolar state', (ROR = 665.98 (95% CI: 272.28-1628.95), PRR = 664.53 (95% CI: 269.75-1637.1)), 'hyperchloremia,' 'hypernatremia' (ROR = 25.18 (95% CI: 17.66-35.9), PRR = 24.85 (95% CI: 17.46-35.36)). CONCLUSIONS: This study underscores the need for vigilant monitoring of mannitol use. Further research is required to understand the mechanisms behind unexpected AEs and establish a comprehensive safety profile.
Dementia-related adverse events associated with direct oral anticoagulants use: a real-world, pharmacovigilance study based on the FAERS database.
Zhang H, Li M, Liu W … +1 more , Yuan H
Expert Opin Drug Saf · 2025 Apr · PMID 40207729 · Publisher ↗
BACKGROUND: Direct oral anticoagulants (DOACs) are commonly used to prevent and treat thromboembolic diseases. This study aimed to assess and compare dementia related adverse events (AEs) associated with DOACs. RESEARCH...
BACKGROUND: Direct oral anticoagulants (DOACs) are commonly used to prevent and treat thromboembolic diseases. This study aimed to assess and compare dementia related adverse events (AEs) associated with DOACs. RESEARCH DESIGN AND METHODS: AEs related to DOACs from January 2014 to June 2023 were extracted from the FDA Adverse Event Reporting System (FAERS) database. Disproportionality analysis methods, including reporting odds ratio (ROR), proportional reporting ratio, Bayesian Confidence Propagation Neural Network, and Multi-Item Gamma Poisson Shrinker, were used to evaluate the association between DOACs and dementia-related AEs. RESULTS: There were 12,692,968 AEs reported in FAERS after deduplication. Among these, 165, 206, 1574, and 12 dementia-related AEs that were attributed to dabigatran, rivaroxaban, apixaban, and edoxaban, respectively. Apixaban showed the strongest association with dementia-related AEs (ROR 7.66, 95% confidence interval (CI) 7.27-8.06), while rivaroxaban had the lowest ROR (0.95, 95%CI 0.83-1.09). Women exhibited higher RORs for all DOACs, with apixaban showing the most significant correlation. Subgroup analysis indicated a significant link between apixaban and dementia, dementia Alzheimer's type and senile dementia. CONCLUSIONS: Apixaban appears most associated with dementia-related AEs among DOACs, whereas rivaroxaban poses a lower risk. Further research is needed to validate these findings through large-scale prospective studies.
Ophthalmotoxicity induced by antibody-drug conjugates: a pharmacovigilance study of the FDA adverse event reporting system (FAERS).
Zhao W, Feng X, Yang S … +5 more , Yuan G, Huang M, Ding L, He Z, Wu J
Expert Opin Drug Saf · 2025 Apr · PMID 40202446 · Publisher ↗
BACKGROUND: Antibody-drug conjugates (ADCs) have demonstrated remarkable therapeutic efficacy in refractory cancers, however, ophthalmotoxicity remains a serious concern. This study aimed to investigate the association b...
BACKGROUND: Antibody-drug conjugates (ADCs) have demonstrated remarkable therapeutic efficacy in refractory cancers, however, ophthalmotoxicity remains a serious concern. This study aimed to investigate the association between ADCs and ophthalmotoxicity. RESEARCH DESIGN AND METHODS: A retrospective pharmacovigilance study was conducted utilizing data extracted from the U.S. Food and Drug Administration Adverse Events Reporting System (FAERS) from 2004 to 2023. Disproportionality analyses were performed using the reporting odds ratio (ROR) and information component (IC), with sensitivity analyses and subgroup evaluations by age and sex. RESULTS: A total of 1992 cases of ophthalmotoxicity linked to ADCs were identified, with a median latency of 40 days. The correlation between ophthalmotoxicity and ADCs was higher than with other medications (IC = 0.67, 95% CI:0.64-0.70). Signal detection revealed 36 adverse events unreported in product labeling. Sensitivity analyses confirmed the robustness of our results on the association between ADCs and ocular toxicity, with higher reporting in females compared to males (OR = 1.25, 95% CI: 1.11-1.40). CONCLUSIONS: ADCs had different profiles of ophthalmotoxicity. Our pharmacovigilance study suggested increased reporting of ophthalmotoxicity associated with ADCs.
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