Pharmacotherapy最新文献

{"title":"Identifying Pediatric Drug Safety Knowledge Gaps: An Integrated Approach Leveraging Real-World Data, a Biomedical Knowledge Base, and Postmarketing Surveillance Data.","authors":"Saurabh Rahurkar, Jiayi Ouyang, Pallavi Jonnalagadda, Xiaofu Liu, Shijun Zhang, Chien-Wei Chiang, Lei Wang, Aditi Shendre, Lang Li","doi":"10.1002/phar.70061","DOIUrl":"https://doi.org/10.1002/phar.70061","url":null,"abstract":"<p><strong>Background: </strong>Drug safety has historically been understudied in pediatric populations, rendering them \"therapeutic orphans.\" Pediatric drug indications and dosages are often inferred by extrapolating safety, efficacy, and dosing data from adult studies, leading to widespread off-label use. However, this approach fails to account for age-specific differences in disease pathophysiology and developmental pharmacokinetics (PK). Despite evidence that adverse drug events (ADEs) manifest with greater severity in pediatric populations than in adults, fewer than 50% of drugs have been systematically studied for pediatric use. The lack of robust drug safety data may result in suboptimal or harmful treatment strategies.</p><p><strong>Methods: </strong>We used a data-driven approach that integrated three databases -including Merative MarketScan claims, the Maternal and Pediatric Precision in Therapeutics (MPRINT) Knowledgebase (including 670,185 pediatric pharmacoepidemiology, PK, and clinical trial publications on 5062 drugs), the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS, a postmarketing safety surveillance database), and FDA drug label data- to identify high-impact target. High-impact targets were defined as drugs that have a high prescription volume, limited safety evidence and high risk of serious ADEs.</p><p><strong>Results: </strong>With 229,550 prescriptions in MarketScan, only 9 studies, and almost 50 high risk serious ADEs benzonatate was identified as a high-impact drug of concern. Serious ADEs included seizure, death, and arrhythmia with proportional reportion ratios (PRRs) ranging from 4.3 to 477.8.</p><p><strong>Conclusion: </strong>Approved in 1958, Benzonatate, a nonnarcotic antitussive agent has a limited safety evidence with only nine PE/PK publications in six decades. Moreover, it is frequently prescribed off-label for cough relief despite questionable effectiveness, and high-risk of serious ADEs. Our findings reveal a disconnect between clinical practice and suppporting safety evidence. As such, there is critical need to study the safety of this drug using emerging real-world data for real-world evidence. In summary, this study presents an approach that is systematic, objective, reproducible, and data driven to identify and prioritize drug-ADE combinations with limited evidence.</p>","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145200618","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Acute Pharmacodynamic Effects of Oral Levodopa on Blood Pressure in Parkinson's Disease.","authors":"Katherine Longardner, Cat Liu, Jeremiah Momper, Kuldeep Mahato, Chochanon Moonla, Hamidreza Ghodsi, Joseph Wang, Irene Litvan","doi":"10.1002/phar.70066","DOIUrl":"https://doi.org/10.1002/phar.70066","url":null,"abstract":"<p><strong>Background: </strong>Levodopa decreases blood pressure (BP) in persons with Parkinson's disease (PwP), but no pharmacodynamic studies integrating systemic levodopa concentration measurements have characterized its hypotensive effects. Understanding this relationship is clinically relevant for guiding therapeutic decisions, such as how aggressively to treat hypotension before initiating or increasing levodopa. In this pilot study, we aimed to determine the acute pharmacodynamic effects of oral immediate-release carbidopa/levodopa on BP in PwP.</p><p><strong>Methods: </strong>PwP taking chronic oral carbidopa/levodopa with baseline BP ≥ 90/60 mmHg were recruited. Participants withheld antiparkinsonian medications overnight prior to the study visit and received carbidopa/levodopa immediate-release tablets at time 0. Capillary blood levodopa levels, seated BP measurements, and motor symptom assessments were performed at baseline and repeated every 10 min for 70-100 min. Non-compartmental pharmacokinetic parameters of levodopa were determined, including the area under the curve up to the last time point (AUC_{0 → last}), maximum concentration (C_max), and time to maximum concentration (T_max).</p><p><strong>Results: </strong>Fourteen PwP were enrolled (mean age 69.5 ± 7.6 years, six females). Two participants had orthostatic hypotension at baseline (defined as a sustained drop in systolic BP ≥ 20 mmHg or diastolic BP ≥ 10 mmHg within 3 min of standing), and six were taking antihypertensive medications. Mean arterial pressure (MAP) declined during the study from an average of 105 ± 13.1 mmHg at baseline to a nadir of 84 ± 15.8 mmHg. The maximum MAP drop occurred at 100 min post-dose. Cumulative levodopa AUC negatively correlated with MAP (Pearson's r = -0.30; p = 0.00036).</p><p><strong>Conclusions: </strong>Oral levodopa is associated with acute hypotension in PwP, and levodopa exposure is inversely correlated with MAP. These effects should be considered when adjusting levodopa dosing, particularly in patients with hypotension, to improve safety outcomes.</p>","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145200622","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Nephrocast-V: A Deep Learning Model for the Prediction of Vancomycin Trough Concentration Using Electronic Health Record Data.","authors":"Ghodsieh Ghanbari, Craig Stevens, Eliah Aronoff-Spencer, Atul Malhotra, Shamim Nemati, Zaid Yousif","doi":"10.1002/phar.70062","DOIUrl":"https://doi.org/10.1002/phar.70062","url":null,"abstract":"<p><strong>Introduction: </strong>Vancomycin is a critical antibiotic for treating methicillin-resistant Staphylococcus aureus and other gram-positive bacterial infections, but achieving and maintaining therapeutic trough concentrations is challenging.</p><p><strong>Objectives: </strong>We hypothesized that a deep learning model could accurately predict vancomycin trough concentrations 2 days in advance in critically ill patients and provide recommendations for optimal dosing adjustments to achieve target drug concentrations.</p><p><strong>Methods: </strong>We trained and validated the model using electronic health record (EHR) data from adults admitted to the University of California San Diego Health system intensive care units (ICUs) from January 1, 2016, to June 30, 2024. Features included patient demographics, comorbidities, vital signs, laboratory measurements, medications, and vancomycin dosing information. The model architecture combined Long Short-Term Memory and Multi-Head Attention layers, supplemented with skip connections to incorporate past dosage information at the final layer of the deep learning model. Model performance was evaluated using mean absolute error (MAE) and root mean square error (RMSE) metrics.</p><p><strong>Results: </strong>A total of 2205 encounters met the eligibility criteria. The median age was 57 years, and the median ICU length of stay was 4.9 days. The model achieved an MAE of 3.15 mg/L and an RMSE of 4.17 mg/L, comparable to that of a critical care pharmacist aided by a Bayesian dosing software. Additionally, deviations from patient-specific model-based dose recommendations were generally associated with nontherapeutic vancomycin levels.</p><p><strong>Conclusion: </strong>This study demonstrates the potential to leverage deep learning to individualize and support vancomycin therapeutic drug monitoring in critically ill patients.</p>","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145192372","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Focusing on an EEG Biomarker, the Photoparoxysmal Response (PPR), to Identify Promising Investigational Anti-Seizure Medications (ASMs) and Differentiate the Efficacy of Existing ASMs.","authors":"Ronald C Reed, Dorothee G A Kasteleijn-Nolst Trenite","doi":"10.1002/phar.70059","DOIUrl":"https://doi.org/10.1002/phar.70059","url":null,"abstract":"","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145192349","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lithium Augmentation in Treatment-Resistant Depression: A Qualitative Review of the Literature.","authors":"Angela Acero-González, Yahira Guzman, Nadia Juliana Proaños, Rosa-Helena Bustos, María Aconcha, Ivan Guerrero, Laura Alejandra Martinez, Michael Berk, Seetal Dodd","doi":"10.1002/phar.70063","DOIUrl":"https://doi.org/10.1002/phar.70063","url":null,"abstract":"<p><p>Depression is the leading cause of disability worldwide, affecting people of all ages. Both pharmacological and non-pharmacological therapies are available for its treatment. However, some patients do not respond to first-line pharmacological interventions, referred to as treatment-resistant depression (TRD). Individuals with TRD face a significantly higher risk of mortality, including an increased risk of suicide. Additionally, TRD poses a substantial economic burden on health care systems. Various treatment options have been explored for TRD, including augmentation of an antidepressant through the use of an additional agent. Lithium salts have shown promising benefits in the TRD. Lithium requires close therapeutic monitoring due to its narrow therapeutic range, with well-defined thresholds for efficacy and toxicity, in addition to its pharmacokinetic characteristics. Furthermore, lithium has been associated with a reduced risk of mortality by lowering aggression, impulsivity, and suicide rates. Compared with other agents used in the management of TRD-such as atypical antidepressants, second-generation antipsychotics (SGAs), ketamine, and thyroid hormones-lithium is considered a cost-effective augmentation option, alongside other evidence-based strategies, and has a well-established efficacy profile. This literature review examines the role of lithium as an augmentation agent in TRD, with a focus on its pharmacological and clinical properties, as well as the current evidence supporting its use.</p>","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145125721","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Synthetic Data-Driven Early Prediction Framework for Acute Kidney Injury in Patients Receiving Vancomycin and Ceftazidime/Avibactam.","authors":"Maryam Ramazani, Todd Brothers, Imtiaz Ahmed, Mohammad A Al-Mamun","doi":"10.1002/phar.70064","DOIUrl":"https://doi.org/10.1002/phar.70064","url":null,"abstract":"<p><strong>Background: </strong>The nephrotoxic risks of combining ceftazidime/avibactam (AVI) with vancomycin (VAN) remain underexplored, despite both agents independently being linked to acute kidney injury (AKI). This study assessed the risk of AKI associated with concurrent VAN and ceftazidime/avibactam (VAN-AVI) therapy and developed synthetic data models to enable early prediction of AKI.</p><p><strong>Methods: </strong>We conducted a retrospective analysis using electronic health record data from hospitalized adults between 2015 and 2022. The incidence of AKI was compared among patients receiving VAN-AVI or VAN in combination with piperacillin/tazobactam (VAN-TPZ) versus VAN monotherapy. AKI was defined as a composite of de novo and recurrent AKI (i.e., patients had a prior diagnosis of AKI within the preceding 6 months and experienced a new AKI event after 7 days of VAN-AVI initiation). To address sample size imbalance, we applied inverse probability of treatment weighting (IPTW) and generated synthetic datasets using Conditional Tabular Generative Adversarial Networks (CTGAN) and Tabular Variational Autoencoders (TVAE). These synthetic datasets were subsequently used to augment machine learning (ML) models aimed at the early prediction of AKI in patients treated with VAN-AVI combination therapy.</p><p><strong>Results: </strong>Among the 92 patients receiving VAN-AVI combination therapy, only four (4.3%) patients experienced new-onset AKI, and 66 (71.7%) patients had a recurrent AKI. After applying IPTW, VAN-AVI was associated with a higher risk of AKI Hazard Ratio (HR) = 3.47; 95% Confidence Interval (CI): 1.97-6.11, followed by VAN-TPZ (HR = 1.96; 95% CI: 1.37-2.81), compared to VAN alone. Synthetic data analyses conducted over 1000 iterations supported these findings, with mean HRs for VAN-AVI of 3.80 using TVAE and 4.45 using CTGAN. ML models augmented with synthetic data outperformed those using original data alone. For 30-day AKI prediction, F1-scores improved across all models, with the highest performance observed in the augmented XGBoost and logistic regression classifier (F1 = 0.80).</p><p><strong>Conclusion: </strong>This study introduces a novel approach that integrates IPTW with synthetic data generation to evaluate drug-associated AKI risk in small-sample cohorts. Although our findings demonstrate a lower incidence of de novo AKI in the VAN-AVI group, the use of synthetic data and augmented ML models significantly improved early AKI prediction. These findings support the potential utility of synthetic data frameworks for scalable drug safety evaluations, although further validation is warranted.</p>","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145125741","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association of Omeprazole-Related Myopathy With Drug-Drug and Drug-Gene Interactions Involving CYP2C19 and CYP3A4: A Nested Case-Control Study.","authors":"Eugene Jeong, Aditi Shendre, Yu Su, Xingyi Guo, Lang Li, You Chen","doi":"10.1002/phar.70058","DOIUrl":"https://doi.org/10.1002/phar.70058","url":null,"abstract":"<p><strong>Background: </strong>Omeprazole, a widely used proton pump inhibitor, has been associated with rare but serious adverse events such as myopathy. Previous research suggests that concurrent use of omeprazole with fluconazole, a potent cytochrome P450 (CYP) 2C19/3A4 inhibitor, may increase the risk of myopathy. However, the contribution of genetic polymorphisms in CYP enzymes remains unclear.</p><p><strong>Aims: </strong>This study leveraged electronic health record (EHR) and biobank data to validate an interaction between omeprazole and fluconazole and to explore drug-gene interactions (DGIs) between omeprazole and polymorphisms in CYP enzymes.</p><p><strong>Materials and methods: </strong>A nested case-control design with incidence-density matching was used. Cases were defined as patients who developed myopathy during ongoing omeprazole therapy. For each case, up to four controls were selected from patients who had not developed myopathy by the time the case was diagnosed. Conditional logistic regression models, adjusting for relevant covariates, evaluated (i) the association between concomitant fluconazole use and myopathy and (ii) genotype-stratified myopathy risk.</p><p><strong>Results: </strong>Among 902 cases and 3608 controls, the combined use of omeprazole and fluconazole was linked to an increased risk of myopathy (adjusted odds ratio [AOR] = 1.75, 95% confidence interval [CI]: 1.17-2.63, p = 0.007). In the DGI analysis, which included 862 cases and 3448 controls, individuals classified as CYP2C19 poor metabolizers paired with CYP3A4 extensive metabolizers showed a significantly higher myopathy risk (AOR = 1.62, 95% CI: 1.03-2.55, p = 0.036); those with CYP2C19 poor metabolizer/CYP3A4 intermediate metabolizer had an even greater risk (AOR = 4.77, 95% CI: 1.74-13.1, p = 0.002).</p><p><strong>Discussion: </strong>These findings not only confirm previously reported drug-drug interactions (DDIs) between omeprazole and fluconazole but also reveal the emerging clinical implications of DGIs.</p><p><strong>Conclusion: </strong>By integrating EHR and genetic data, the study showcases how informatics tools can translate DDI findings into DGI hypotheses, effectively bridging genetic insights and clinical outcomes.</p>","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145016047","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Use of Plasma Exchange for Clozapine Intoxication: A Case Report.","authors":"Bradley J Peters, Luz Y Sullivan, Rebecca L Lange, Katie W Jones, Misbah Baqir","doi":"10.1002/phar.70057","DOIUrl":"https://doi.org/10.1002/phar.70057","url":null,"abstract":"<p><p>We describe a case of a 56-year-old male who developed severe, refractory hypotension after an intentional ingestion of clozapine and who became hemodynamically stable after one session of therapeutic plasma exchange (TPE). The patient, who presented after an ingestion of clozapine, was found to have altered mental status and hypotension in the emergency department. Escalating catecholamine vasoactive agents were necessary to maintain adequate hemodynamics. Angiotensin II was added and rapidly up titrated in efforts to maintain adequate blood pressure. Due to persistent hemodynamic instability despite four vasoactive agents, TPE was attempted to enhance the elimination of the highly protein bound medication. Within 2 h of completing TPE, the catecholamines and vasopressin were stopped, and angiotensin II dosing was significantly decreased. This is the first report of utilizing TPE as a method of enhanced elimination of a toxic clozapine ingestion resulting in severe hemodynamic compromise. Further study is necessary to determine if TPE should be incorporated into the care of patients experiencing clozapine toxicity.</p>","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145016049","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Multicenter, Open-Label Study to Assess the Safety of Nebulized Tissue Plasminogen Activator for the Acute Treatment of Pediatric Plastic Bronchitis: The PLATyPuS Trial.","authors":"Kathleen A Stringer, David Goldberg, Sharon Chen, Philip Thrush, Eric M Graham, Adam Lubert, Jeffrey Myers, Laura McLellan, Thomas Flott, Samya Nasr, Kurt R Schumacher","doi":"10.1002/phar.70056","DOIUrl":"https://doi.org/10.1002/phar.70056","url":null,"abstract":"<p><strong>Introduction: </strong>Pediatric plastic bronchitis (PB) is a rare complication of surgically palliated congenital heart disease (CHD). Fibrin casts obstruct airways and can cause respiratory distress. There are no therapeutics approved by the United States Food and Drug Administration to treat PB, but inhaled tissue plasminogen activator (tPA) has been anecdotally used to relieve symptoms. We conducted a phase II open-label clinical trial to test the safety of inhaled tPA in pediatric PB.</p><p><strong>Methods: </strong>Patients with an acute exacerbation of PB requiring hospitalization were enrolled to test the safety of an inhaled tPA regimen (5 mg every 6 h). The primary end point was to assess the safety and tolerability of repeated doses of nebulized, inhaled tPA in pediatric patients with acute PB. Safety parameters consisted of clinical laboratories to assess bleeding, which were measured prior to, during, and after tPA treatment. To benchmark efficacy using spirometry and oxygen saturation, children with Fontan-palliated CHD without a history of PB, with and without protein losing enteropathy (PLE), and healthy children were enrolled in a control arm that did not receive tPA.</p><p><strong>Results: </strong>Of the 10 patients with PB screened for enrollment, eight qualified for immediate treatment with inhaled tPA. A total of 29 non-PB participants (PLE, n = 8 [10-18 yo]; CHD, n = 9 [8-17 yo]; and healthy, n = 12 [7-16 yo]) were enrolled. There were no differences in pretreatment clinical blood laboratory values of hemostasis and those during and after treatment with the study drug (primary safety outcome). However, there were four episodes of self-limiting epistaxis related to the study drug. Inhaled tPA statistically improved oxygen saturation although this was moderate and likely not clinically significant; inhaled tPA did not alter spirometry values.</p><p><strong>Conclusion: </strong>In this small, phase II study, repeated doses of inhaled tPA in patients with an acute exacerbation of PB did not result in disrupted systemic coagulation or hematological homeostasis or serious bleeding. However, patients should be monitored for localized bleeding. Larger, randomized trials are needed to provide more comprehensive assessments of bleeding risk and to further assess efficacy.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier: NCT02315898.</p>","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145001200","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Severe Persistent Urinary Retention Following Treatment With Intravenous Lecanemab: Urinary Retention With IV Lecanemab.","authors":"Amber N Navarra, Laura A Wang, Heba Al-Sahlani, Andy J Liu, P Murali Doraiswamy","doi":"10.1002/phar.70060","DOIUrl":"https://doi.org/10.1002/phar.70060","url":null,"abstract":"<p><p>Lecanemab is an amyloid-targeted antibody indicated for treating patients with amyloid-confirmed early Alzheimer's Disease in mild dementia or mild cognitive impairment stages. We report here a case of a subject with early stage of Alzheimer's Disease dementia, amyloid positive, who developed severe acute urinary retention following his first dose of intravenous lecanemab. His urinary retention resolved after a week but recurred following the second intravenous dose 2 weeks later. Lecanemab was discontinued, but the urinary retention has persisted for 8 months indicating possible permanent adverse impact on the bladder. The Naranjo causality probability score was 6. The incidence of urinary retention with intravenous lecanemab is not known but given that elderly patients with dementia may have multiple risks for bladder dysfunction, clinicians should remain vigilant. It is hoped that newer formulations, such as subcutaneous lecanemab, may prove safer in such patients.</p>","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145001269","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}