Triptorelin associated adverse events evaluated using FAERS pharmacovigilance data

BackgroundAlthough filgotinib, a selective Janus kinase 1 inhibitor, has been increasingly applied in the treatment of inflammatory diseases, its comprehensive safety profile remains insufficiently characterized. Using data from the FAERS database covering Q1 2014 to Q2 2024, this study attempts to analyze adverse event signals linked to filgotinib and provide guidance for the safe and sensible clinical usage of filgotinib.MethodsFrom Q1 2014 to Q2 2024, information on adverse drug events (ADEs) associated with filgotinib was gathered. The reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) were among the signal detection methods that were employed for analysis following data normalization.ResultsFilgotinib was shown to be the main suspected medication in ADE reports, exposing 103 preferred terms (PTs) in 17 system organ classes (SOCs). Infections, gastrointestinal disorders, and musculoskeletal and connective tissue disorders were the most commonly reported adverse effects. Additionally, atrial fibrillation, alopecia, elevated serum creatinine, blood creatinine increased, pulmonary embolism, epididymitis, respiratory failure, and osteopenia were identified as potential disproportionate reporting signals for filgotinib, although these were not listed in the official drug label. Notable significant signals included large intestine erosion (ROR 2186.05, 95%CI(ROR): 1015.94–4703.86, PRR 2176.18, 95%CI(PRR): 1014.64–4667.42), mesenteric arterial occlusion (ROR 1832.17, 95%CI(ROR): 897.68–3739.48, PRR 1822.71, 95%CI(PRR): 896.17–3707.20), repetitive strain injury (ROR 1149.27, 95%CI(ROR): 363.16–3637.01, PRR 1147.05, 95%CI(PRR): 363.24–3622.15), oligoarthritis (ROR 755.02, 95%CI(ROR): 310.74–1834.54, PRR 752.59, 95%CI(PRR): 310.60–1823.51), and periostitis (ROR 676.03, 95%CI(ROR): 319.36–1431.06, PRR 672.98, 95%CI(PRR): 318.97–1419.87). The subgroup analysis identified obvious sex and age-specific trends in filgotinib-related adverse reactions, emphasizing a higher risk of renal disorders in females, a preponderance of gastrointestinal events in males, and age-dependent trends involving mesenteric occlusion, increased serum creatinine, and immunoglobulin reduction.ConclusionWhile filgotinib demonstrates therapeutic efficacy, it is associated with a range of potential adverse events, underscoring the need for vigilant clinical monitoring. Particular attention should be given to gastrointestinal, cardiovascular, respiratory, and metabolic complications.

Deucravacitinib, a selective inhibitor of TYK2 kinase, has been recently approved for the treatment of moderate to severe plaque psoriasis. Although the safety of deucravacitinib has been observed in clinical trials, its safety in the real world remains to be fully understood. The purpose of this study was to analyze post-marketing adverse events (AEs) associated with deucravacitinib using data from the Food and Drug Administration Adverse Event Reporting System (FAERS) to better understand its safety in real-world conditions. This study performed a retrospective analysis of AEs associated with deucravacitinib from the FAERS database, spanning from the third quarter of 2022 to the second quarter of 2024. AEs were classified according to the Medical Dictionary for Regulatory Activities (MedDRA, Version 27.0). Disproportionality analysis was conducted using several statistical methods, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Multi-Item Gamma Poisson Shrinker, and Bayesian Confidence Propagation Neural Network. Additionally, time-to-onset analyses and sensitivity analyses were performed to provide a comprehensive assessment. AE reports from 1573 individuals were analyzed, revealing a total of 2895 AEs. Most of these events occurred within the first month of treatment. The primary AEs were associated with skin and subcutaneous tissue disorders, as well as infections and infestations. The study confirmed several known common AEs, including acne (n = 172, ROR 75, PRR 70.61, EBGM 69.14, IC 6.11), folliculitis (n = 51, ROR 62.45, PRR 61.37, EBGM 60.25, IC 5.91), and herpes zoster (n = 18, ROR 6.46, PRR 6.43, EBGM 6.42, IC 2.68), and identified some unexpected AEs such as urticaria (n = 36, ROR, PRR 5.27, EBGM 5.27, IC 2.4), skin burning sensation (n = 42, ROR 21.84, PRR 21.54, EBGM 21.41, IC 4.42), and myalgia (n = 26, ROR 3.93, PRR 3.9, EBGM 3.9, IC 1.96). Our study confirms the known AEs associated with deucravacitinib and identifies several potential AEs. These findings provide preliminary safety data for the practical use of deucravacitinib.

Nifedipine, a dihydropyridine calcium channel blocker, is widely used in the management of hypertension and as a tocolytic agent to delay preterm labor, including in pregnant women. However, its safety profile, particularly in pregnant populations, remains insufficiently characterized. This study aimed to evaluate adverse event (AE) signals associated with nifedipine use, with a specific focus on pregnancy-related outcomes. Nifedipine-related AEs reported in U.S. Food and Drug Administration Adverse Event Reporting System database (Q1 2004–Q4 2024) were analyzed. Disproportionality analysis was conducted using 4 established signal detection methods: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network, and Multi-item Gamma Poisson Shrinker. Pregnancy-related reports were identified using Standardized MedDRA Queries, and subgroup analyses were conducted for pregnant women. In the overall population, significant signals at the System Organ Class level were observed for pregnancy-related conditions, vascular disorders, and cardiac disorders. The strongest prominent preferred term signal was gingival hypertrophy (n = 52; ROR = 100.55, PRR = 100.23, information component [IC] = 6.61, empirical Bayesian geometric mean [EBGM] = 97.42). Among pregnant women, prominent signals at the System Organ Class level included vascular disorders, respiratory disorders, and cardiac disorders. The strongest preferred term signal was acute pulmonary edema (n = 27; ROR = 67.23, PRR = 66.70, IC = 5.87, EBGM = 58.29), followed by cardiogenic shock (n = 11; ROR = 41.80, PRR = 41.67, IC = 5.26, EBGM = 38.25), pulmonary edema (n = 51; ROR = 38.57, PRR = 38.00, IC = 5.14, EBGM = 35.15), and hypoxia (n = 28; ROR = 20.62, PRR = 20.46, IC = 4.29, EBGM = 19.62). Several unexpected pregnancy-related AEs were also detected, including eclampsia, fetal distress, placental disorders, and intrauterine growth restriction. This study identified unexpected AE signals associated with nifedipine use during pregnancy. The findings offer valuable insights to guide clinical decision-making and promote safer use of nifedipine in pregnant populations.

Background Tazemetostat is an oral inhibitor of enhancer of zeste homolog 2 (EZH2) and is used for the treatment of epithelioid sarcoma (ES) and follicular lymphoma (FL). In this study, we investigated the adverse events (AEs) of tazemetostat based on real data from the U.S Food and Drug Administration(FDA) Adverse Event Reporting System (FAERS). Methods To quantify the signals of AEs associated with tazemetostat, we employed disproportionality analyze, including 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 7,133,678 reports of AEs were collected from the FAERS database, of which 1,110 reports were identified with tazemetostat as the “primary suspect (PS)”. A total of 32 significant disproportionality preferred terms(PTs) conforming to the four algorithms were simultaneously retained. There were multiple unexpected AEs caused by tazemetostat that were not mentioned in the label yet, including pleural effusion (ROR = 3.84, PRR = 3.83, IC = 3.83, IBGM = 1.94), lymphadenopathy (ROR = 3.88, PRR = 3.88, IC = 3.87, IBGM = 1.95) and taste disorder(ROR = 20.48, PRR = 20.23, IC = 20.16, IBGM = 4.33). Additionally, the majority of tazemetostat-associated AEs occurred within the first month of treatment initiation (n = 126, 49.8%). Conclusion Clinicians need to monitor safety for tazemetostat during the first 30 days and pay more attention to new AE signals.

Mitomycin, a cytotoxic antitumor antibiotic, has been approved for the treatment of low-grade upper tract urothelial carcinoma (UTUC) and non-muscle invasive bladder cancer (NMIBC). It is also used off-label in ophthalmic procedures and gastrointestinal malignancies. Although the efficacy of mitomycin is well recognized, its safety profile, particularly regarding rare or serious adverse events (AEs), remains insufficiently characterized in large real-world populations. This study aimed to evaluate mitomycin-associated AEs through comprehensive analysis of two major global pharmacovigilance databases, with the goal of identifying high-risk organ systems and specific AE signals requiring increased clinical awareness. AE data were retrieved from the FDA Adverse Event Reporting System (FAERS) covering Q1 2004 to Q3 2024. Data were deduplicated and standardized according to MedDRA terminology. Complementary data were collected from the World Health Organization VigiAccess database. Disproportionality analysis was performed using four signal detection algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). The time-to-onset of adverse events was analyzed using non-parametric statistical methods. A total of 1461 mitomycin-related reports, comprising 3652 AEs, were identified in the FAERS database. Notably, strong safety signals have emerged at the system organ class (SOC) level for eye, renal and urinary, blood and lymphatic system, and skin and subcutaneous tissue disorders. At the preferred term (PT) level, high disproportionality values were observed for serious events, such as scleral thinning (OR = 7129.60, 95% CI 4576.64-11,106.7) and bladder perforation (OR = 1585.69, 95% CI 1111.91-2261.33). Over two-thirds of AEs occurred within 30days of drug administration, although 68.93% of the reports lacked valid onset-time data. The VigiAccess findings corroborated the SOC trends observed in FAERS. Mitomycin is associated with a broad range of organ-specific toxicities, many of which occur early in the treatment course and may have serious clinical consequences. This study highlights the need for early risk identification, individualized monitoring strategies, and greater pharmacovigilance in populations treated with mitomycin. These findings provide an important foundation for optimizing the safe and effective use of mitomycin in oncology and in other therapeutic settings.

Enfortumab vedotin (EV) is an antibody-drug conjugate (ADC) that has been approved by the FDA for patients with locally advanced or metastatic urothelial carcinoma (UC). This study presents a comprehensive pharmacovigilance analysis of the post-marketing safety profile of EV in the real-world based on the US Food and Drug Administration Adverse Event Reporting System (FAERS). Adverse event (AE) reports regarding EV between January 2020 and December 2023 were obtained from the FAERS database. The standardized MedDRA query (SMQ) narrow search AEs on the preferred term (PT) level were used. Disproportionality analysis was performed to identify the AE signals for EV with the reporting odds ratio (ROR), proportional reporting ratio (PRR), multi-item gamma Poisson shrinker (MGPS), and Bayesian confidence propagation neural network (BCPNN). A total of 2,216 reports regarding EV were included in the present study. SMQ analysis results indicated that a stronger strength signal was found in severe cutaneous adverse reactions, retroperitoneal fibrosis, and peripheral neuropathy. A total of 116 significant disproportionality PTs referring to 14 system organ classes (SOCs) were retained by disproportionality analysis, with 49 PTs not listed on the EV drug label. Frequently reported EV-related AEs included rash, peripheral neuropathy, decreased appetite, alopecia, and pruritus. The time to onset of the majority of EV-related AEs was within 30 days (66.05%), with only 0.73% events occurring after 1 year. The disproportionality analysis highlights that dermatologic toxicity and peripheral neuropathy were the major AEs induced by EV. The potential AEs not listed on the drug label were mainly related to gastrointestinal, hepatic, and pulmonary events. Further research is needed to confirm and explore the EV-related AEs in clinical practice.

BackgroundTo date, no post-marketing safety studies of satralizumab have been conducted. This study aims to evaluate the post-marketing safety profile of satralizumab using data from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER) databases.MethodsWe extracted all adverse event (AE) reports related to satralizumab from the FAERS database covering the period from Q1–2023 to Q4 2024. Disproportionality analyses were conducted for AEs with at least four reports listing satralizumab as the primary suspect (PS), using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS), along with their corresponding 95% confidence intervals (CI). Non-parametric tests were applied to compare differences between serious and non-serious outcomes.ResultsSince its approval, a total of 2,527 AEs related to satralizumab have been reported in the FAERS database, involving 931 individual patients. Among them, 355 patients experienced serious outcomes, including 389 fatal cases. The most frequently reported AEs were infection-related, such as urinary tract infection (n = 72), infectious pneumonia (n = 44), COVID-19 (n = 43), sepsis (n = 23), and cellulitis (n = 17). In addition, several unexpected AEs were identified, including cerebral infarction and malignancies. Compared with patients experiencing non-serious outcomes, male patients were more likely to develop serious outcomes, which also tended to occur earlier in the treatment course. Furthermore, the standard usage (120 mg once every 2 weeks for three doses at Weeks 0, 2, and 4, followed by 120 mg once every 4 weeks) was associated with a relatively favorable safety profile.ConclusionThe adverse risks associated with satralizumab are notable. Our findings provide evidence to support risk assessment in clinical practice; however, high-quality clinical studies are still needed to validate these results and to further explore the long-term safety and efficacy of the drug.

To characterize the real-world safety profile of 23 monoclonal antibodies (mAbs) carrying US Food and Drug Administration (FDA) black box warnings (BBWs) by applying disproportionality analysis to safety reports in the FDA Adverse Event Reporting System (FAERS) from Q1 2021 to Q2 2025. Although mAbs have transformed the treatment of cancer, autoimmune, and rare diseases, several remain associated with serious or life-threatening adverse events (AEs) that warrant continuous postmarketing monitoring. FAERS reports involving the 23 mAbs were screened for BBW-related AEs using MedDRA Preferred Terms. Each drug-event pair was analyzed through 2×2 contingency tables. Disproportionality signals were identified using the proportional reporting ratio (PRR), reporting odds ratio (ROR), chi-square (χ²), and 95% confidence interval (CI) for ROR. Bayesian analysis was also performed using the Bayesian Confidence Propagation Neural Network (BCPNN) approach to calculate the Information Component (IC) and its lower bound (IC₀₂₅). A signal was considered present when the PRR was ≥2, χ² value was ≥4, and at least 3 individual case safety reports (ICSRs) were available for a given drug-event pair. ROR signals were considered statistically significant when the lower bound of the 95% CI exceeded 1. In addition, BCPNN analysis was performed, and signals were considered significant when the lower limit of the 95% CI of the IC 025 was greater than 0. Temporal patterns in adverse event reporting were examined by summarizing FAERS reports and corresponding disproportionality metrics for each drug-event pair on a quarterly basis from Q1 2021 to Q2 2025. Changes across quarters were evaluated by directly comparing the number of reported cases and calculated signal measures between time periods. The study looked at patterns over time using simple comparisons, without using formal statistical techniques such as time-series analysis or regression modeling to test significance or predict trends. Out of 13,462,218 total FAERS reports, 330,851 involved the 23 mAbs. The strongest signal was ipilimumab-immune-mediated dermatitis (PRR 232.12; ROR 250.41; IC₀₂₅ 4.21; χ² 4003.3). Panitumumab showed the highest Bayesian certainty for skin toxicity (IC₀₂₅ 4.61), and ipilimumab-immune-mediated enterocolitis had the highest χ² value (13,320.3). Reporting trends for most mAbs remained consistent over time, though immune checkpoint inhibitors demonstrated a gradual increase in signal intensity across quarters. BBW-related adverse events for mAbs remain prominent in postmarketing data. Immune-related toxicities, especially with checkpoint inhibitors, show rising trends. However, as disproportionality analyses are based from reporting patterns of adverse events within the FAERS database rather than true incidence rates, the identified signals should be considered exploratory and warrant confirmation through well-designed pharmacoepidemiological studies. These findings reinforce the need for continued pharmacovigilance to support risk-benefit evaluation and patient safety.

ABSTRACTBackgroundThere remains a gap in understanding lapatinib's real-world safety, particularly in rare adverse events (AEs). Thus, this study aims to evaluate lapatinib’s safety by (1) performing data mining of the FDA Adverse Event Reporting System (FAERS); and (2) detecting and analysing safety signals associated with lapatinib that may require monitoring.MethodsFAERS data from March 2007 to July 2024 were analysed via OpenVigil (version 2.1). AEs were categorised into preferred terms (PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities. We used descriptive analysis to analyse report characteristics and four signal detection algorithms to quantify risk signals, including Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Multi-item Gamma Poisson Shrinker (MGPS), and Bayesian Confidence Propagation Neural Network (BCPNN). Top novel strong suspected AEs were further assessed using a case-by-case analysis. The Naranjo algorithm was utilised to determine the potential relation between the suspected AEs and lapatinib.ResultsFrom 25,506,744 retrieved reports, 18,407 PTs identified lapatinib as the primary suspect, resulting in 10,959 signals analysed. AEs were predominantly females (77.9%) and individuals aged 18–64 (45.38%). Lapatinib-induced AEs affected 16 systems, with 155 lapatinib-related PTs; 115 of these were significantly disproportionate, including 57 new PTs. While gastrointestinal and dermatological disorders were the most common, the latter was more strongly associated with lapatinib, with diarrhoea being the only strong gastrointestinal signal. Notably, cardiac events were less reported, and the top new AEs based on signal strength, such as hypocapnia, lip ulceration, and hepatic infection, were mostly found to be ‘possibly’ related to lapatinib based on the case-by-case evaluation, warranting further clinical assessments. Initial or prolonged hospitalisation, death, and life-threatening events were the most common AEs outcomes reported, accounting for 28.79%, 13.79%, and 3.06%, respectively.ConclusionThis study provides valuable insights into lapatinib-induced toxicity in real-world settings.

Voclosporin, a novel calcineurin inhibitor (CNI), was FDA-approved in 2021 for treating lupus nephritis (LN). However, post-marketing studies and reports on adverse events (AEs) associated with voclosporin remain limited. This study analyzes voclosporin-associated AEs using FDA Adverse Event Reporting System (FAERS) data. AEs with voclosporin as the primary suspected (PS) drug were extracted from the FAERS database, covering the period from the first quarter of 2021 to the second quarter of 2024. Disproportionality analysis, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS), was used to analyze AE signals. We identified 3,785 reports of AEs associated with voclosporin as PS, encompassing a total of 10,795 AEs. After applying 4 disproportionality algorithms, 6 system organ classes (SOCs) and 88 preferred terms (PTs) were detected, respectively. AEs with the strongest signal intensities included: glomerular filtration rate decreased, urine protein/creatinine ratio increased, hypertension, diarrhea, headache, and blood potassium increased. The median onset time for AEs was 56 days (interquartile range 4-208 days), with ~43% of AEs occurring within the first month of commencing voclosporin therapy. Our findings are consistent with AEs reported in previous clinical trials and outlined in the drug's labeling. The study results further confirm the reliability of the adverse reactions listed in the prescribing information.

BackgroundAs a novel anti-influenza agent, baloxavir marboxil lacks real-world safety data in large populations. Therefore, this study aimed to investigate adverse drug events (ADEs) associated with baloxavir marboxil by analyzing the Food and Drug Administration Adverse Event Reporting System (FAERS) database.MethodsAdverse event reports involving baloxavir marboxil were extracted from the FAERS database spanning the fourth quarter of 2018 to the third quarter of 2023. Demographic characteristics and reporter profiles were analyzed to characterize the exposed population. A disproportionality analysis was performed using four validated pharmacovigilance algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). These complementary approaches were employed to detect, prioritize, and validate potential safety signals.ResultsAnalysis of 8,824,675 ADE reports from the FAERS database identified 1,654 cases (0.19%) associated with baloxavir marboxil. Pediatric patients (< 18 years) exhibited the highest ADE reporting rate. Geospatial analysis revealed marked clustering, with 98.97% of reports originating from the United States (63.2%) and Japan (35.77%). We detected 47 significant safety signals spanning 27 System Organ Classes (SOCs), including established reactions such as pneumonia (n = 90) and vomiting (n = 77). Novel signals emerging from the analysis comprised hemorrhagic diathesis (n = 3), rhabdomyolysis (n = 25), hepatic dysfunction (n = 13), and cardiorespiratory arrest (n = 7). Notably, bleeding-related events (e.g., ischemic colitis, IC025 = 5.03) and neurological complications (e.g., febrile delirium, IC025 = 9.12) demonstrated statistically significant associations.ConclusionThis pharmacovigilance study identifies previously undercharacterized safety signals associated with baloxavir marboxil, including hemorrhagic complications, liver dysfunction, rhabdomyolysis, and life-threatening cardiorespiratory events. Pediatric populations and patients on anticoagulants may require heightened monitoring. While these findings provide critical pharmacovigilance insights, our study is inherently constrained by the spontaneous reporting system, which introduces potential underreporting, reporting biases, and confounding factors. Future research could employ more rigorous prospective study designs, integrating clinical trials and epidemiological studies, to more accurately assess the safety risks of baloxavir marboxil.

Potassium citrate is widely used as oral alkali therapy for the prevention of recurrent nephrolithiasis. Despite its long-standing clinical use, systematically collected real-world safety data remain limited. We performed a pharmacovigilance analysis to characterize adverse event reports associated with potassium citrate using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). FAERS reports submitted between 2014 and 2025 listing potassium citrate as the primary suspect drug were analyzed. Duplicate records were removed, and adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at both the system organ class and standardized event term levels (preferred terms, PTs). Disproportionality analyses were conducted using reporting odds ratio, proportional reporting ratio, bayesian confidence propagation neural network, and multi-item gamma poisson shrinker methods. A total of 408 unique reports were included. Most reports involved adults and were physician-reported from the United States. Disproportionality analysis identified potential safety issues (signals), defined as drug event associations reported more frequently than expected in FAERS and therefore warranting further evaluation, although not establishing causality. The strongest associations involved product-related issues, laboratory investigations, and gastrointestinal disorders. When these potential safety issues were described using standardized MedDRA event terms most reflected formulation- and administration-related problems, including tablet residue in stool, abnormal solubility, swallowing difficulty, throat irritation, and foreign body sensations. Reports of rash were infrequent. This first FAERS-based analysis of potassium citrate highlights that most reported adverse events are related to formulation and administration characteristics rather than drug toxicity. These findings support the overall tolerability of potassium citrate while underscoring the importance of adherence, patient education, and formulation-specific considerations in clinical practice. As a spontaneous reporting system, FAERS is valuable for hypothesis generation, label expansion, and post-marketing surveillance, but it is not suitable for estimating the incidence or absolute risk of adverse events.

ABSTRACTBackgroundMelanosis is an acquired hyperpigmentation disorder that can be associated with the use of medications; timely identification and discontinuation of relevant medications is an important aspect of clinical management.ObjectiveThis study investigates the relationship between melanosis and drug exposure based on data from the FDA Adverse Event Reporting System (FAERS) database. We sought to determine the top drugs reported in association with melanosis in the FAERS.MethodsA retrospective analysis of FAERS data from January 2004 to June 2024 was conducted to identify reports related to melanosis, using the Comprehensive Medical Dictionary for Regulatory Activities (MedDRA) terminology. A total of 18 182 912 independent adverse event reports were processed, and signal mining analyses were performed to detect associations between drugs and melanosis. Disproportionality analyses were conducted using four algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi‐item gamma Poisson shrinker (MGPS). The most frequently reported drugs and their associated adverse event reports were analyzed.ResultsHundred and one reports related to melanosis were screened, involving 73 drug names as primary suspect (PS). By combining and organizing the different names of drugs such as trade names and generic names, 66 drugs were obtained. The top five drugs associated with melanosis were talimogene laherparepvec (ROR: 1891.39), followed by ferrous sulfate (ROR: 997.14), minocycline (ROR: 176.05), vemurafenib (ROR: 97.64), and pembrolizumab (ROR: 19.73).ConclusionPatients who experience drug‐induced melanosis generally have bad outcomes, underscoring the imperative for heightened clinical surveillance regarding the risk of drug‐induced melanosis.

Lecanemab is a humanized murine IgG1 antibody. Recent Phase 3 clinical trials have demonstrated its ability to reduce brain amyloid-β (Aβ) load and slow cognitive decline in patients with early Alzheimer's disease (AD). However, since its approval, reports on adverse effects (AEs) associated with lecanemab have been limited. To better understand the AEs related to lecanemab and provide guidance for future clinical use, we analyzed lecanemab-associated AEs using data from the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). We extracted all AEs reports from the FAERS database for the period from the first quarter of 2023 to the third quarter of 2024. Using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS) algorithms, we conducted a comprehensive analysis of lecanemab-related AEs, restricting the analysis to AEs with the role code of primary suspect (PS). A total of 811 AEs reports related to lecanemab used in AD patients and 506 AEs in Non-AD patients were included. The preferred terms (PTs) identified as positive across all four algorithms included headache, Amyloid Related Imaging Abnormalities-oedema/effusion (ARIA-E), chills, Amyloid Related Imaging Abnormalities-haemosiderosis/microhaemorrhage (ARIA-H), fatigue, infusion-related reaction, nausea, pyrexia, pain, influenza like illness, and so on. Among these, ARIA-E, ARIA-H, brain oedema and status epilepticus were associated with Important Medical Events (IMEs) for AD patients, and brain oedema, cerebral haemorrhage, cerebral microhaemorrhage, subdural haematoma, ischaemic stroke, cerebral infarction were associated with IMEs for Non-AD patients. At the system organ class (SOC) level, the highest signal detection for lecanemab was observed in nervous system disorders among AD and Non-AD patients [ROR for AD: 2.42 (2.2-2.65); ROR for Non-AD: 6.97 (6.12-7.95)]. The median time to the occurrence of these AEs was 44 days after administration in AD patients and 30 days for Non-AD patients. This study utilized the FAERS database to evaluate lecanemab-associated AEs in AD and non-AD patients, along with their temporal patterns post-marketing authorization, thereby establishing a foundation for subsequent clinical pharmacovigilance. A biweekly 10mg/kg was identified as the optimal therapeutic dosage. ARIA emerged as frequent treatment-related AEs, with APOEɛ4 carriers demonstrating heightened susceptibility. This necessitates serial brain MRI surveillance for all patients during treatment, aimed not only at early ARIA detection but also vigilant monitoring of IMEs including cerebral haemorrhage, cerebral microhaemorrhages, subdural haematoma, cerebral edema, ischaemic stroke, and cerebral infarction. While AD patients predominantly exhibited non-specific clinical manifestations, non-AD cohorts showed elevated risks of stroke-related complications. Consequently, dynamic neurological deficit monitoring is indispensable for non-AD populations receiving lecanemab to mitigate adverse outcomes. Finally, comprehensive reassessment of anticoagulant or antiplatelet therapy indications is warranted in both AD and non-AD patients to reduce hemorrhagic risks.

Colitis following the use of immune checkpoint inhibitors: A real-world analysis of spontaneous reports submitted to the FDA adverse event reporting system