The International journal of risk & safety in medicine最新文献

{"title":"Post-SSRI Sexual Dysfunction (PSSD): A comprehensive review of epidemiology, pathophysiology, and clinical management.","authors":"Mingfeng Xie, Pei Huang, Shihuai Wang, Jingyi Ma, Yan Zeng, Jie Sun","doi":"10.1177/09246479261468499","DOIUrl":"https://doi.org/10.1177/09246479261468499","url":null,"abstract":"<p><p>BackgroundSelective serotonin reuptake inhibitors (SSRIs) are first-line treatments for depression but are associated with significant sexual side effects. Post-SSRI Sexual Dysfunction (PSSD) describes a persistent syndrome of sexual dysfunction, including genital anesthesia and anhedonia, that continues or emerges after drug cessation. Despite recent warnings from regulatory bodies like the EMA, PSSD remains under-recognized.MethodsA systematic review was conducted using PubMed, Web of Science, and Scopus databases up to April 2024. Studies focusing on PSSD pathophysiology, diagnostic criteria, and therapeutic interventions were analyzed.ResultsPrevalence estimates suggest persistent symptoms in up to 74% of affected cohorts beyond 6 months. The pathophysiology is multifactorial, involving 5-HT1A receptor desensitization, neurosteroid (allopregnanolone) depletion via 5α-reductase inhibition, and epigenetic silencing of dopaminergic reward circuits. Diagnosis is clinical, based on 2022 standardized criteria, distinguishing PSSD from depressive relapse by specific somatic symptoms like genital numbness. No FDA-approved treatments exist, though off-label use of dopamine agonists and low-power laser therapy shows preliminary promise.ConclusionPSSD is a severe iatrogenic condition requiring heightened pharmacovigilance. Future research must prioritize biomarker identification and prospective trials for targeted neurosteroid therapies.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"9246479261468499"},"PeriodicalIF":0.8,"publicationDate":"2026-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148428544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug-induced multisystem syndromes: An overlooked challenge in pharmacovigilance.","authors":"Uttam Udesh Rai, Mohd Haneef, Sourabh Kosey, Ratima Sood","doi":"10.1177/09246479261458062","DOIUrl":"https://doi.org/10.1177/09246479261458062","url":null,"abstract":"<p><p>BackgroundDrug-Induced Multisystem Syndromes (DIMS) represent a clinically significant yet under-recognized group of delayed immune-mediated adverse drug reactions characterized by heterogeneous clinical presentations, diagnostic uncertainty, and substantial morbidity. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Drug-Induced Hypersensitivity Syndrome (DIHS) are prototypical conditions within this spectrum.MethodsThis narrative review synthesizes current evidence on the immunopathogenesis, pharmacogenomic susceptibility, clinical manifestations, diagnostic challenges, and pharmacovigilance strategies associated with delayed multisystem drug hypersensitivity reactions. The DIMS framework is proposed as a mechanistic, hypothesis-driven construct intended to enhance pharmacovigilance signal recognition rather than replace existing diagnostic classifications.ResultsDIMS typically develop weeks after drug exposure and involve multisystem inflammatory injury affecting organs such as the liver, kidney, lungs, and heart. T-cell-mediated immune activation, cytokine amplification, and viral reactivation are central pathogenic mechanisms. Mortality varies by syndrome subtype, ranging from approximately 5-10% in DRESS/DIHS to 25-35% in Toxic Epidermal Necrolysis (TEN). Pharmacogenomic factors, including HLA alleles and cytochrome P450 polymorphisms, contribute to susceptibility.ConclusionThe DIMS framework may support improved early recognition, pharmacovigilance signal detection, and prevention strategies. Integration of pharmacogenomics and artificial intelligence-based analytics may facilitate risk stratification and safer, personalized therapeutic decision-making.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"9246479261458062"},"PeriodicalIF":0.8,"publicationDate":"2026-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148255420","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Concerning the harm-benefit ratio of escitalopram for pediatric generalized anxiety disorder. A critical viewpoint on the evidence and approval process.","authors":"Martin Plöderl, Mark Horowitz, Florian Naudet, John Warren, Joanna Moncrieff","doi":"10.1177/09246479261456063","DOIUrl":"https://doi.org/10.1177/09246479261456063","url":null,"abstract":"<p><p>In this commentary we review the recent approval of escitalopram for generalized anxiety disorder (GAD) in children and adolescents. We critically discuss the FDA approval document and the approval trial. In the approval trial, efficacy was not clinically meaningful, statistical significance uncertain, and there were significantly more adverse events with escitalopram than with placebo. Relative to placebo, children and adolescents exposed to escitalopram were more likely to become suicidal than to experience a clinically relevant improvement in anxiety. Overall, the harm-benefit ratio seems problematic for escitalopram for pediatric GAD.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"9246479261456063"},"PeriodicalIF":0.8,"publicationDate":"2026-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148045453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evidence base for pharmacotherapy effectiveness in patients with acute myocardial infarction: The role of treatment adherence assessment using EMIAS data.","authors":"Sergey B Fitilev, Irina I Shkrebniova, Dmitry A Kliuev, Mikhail I Smirnov","doi":"10.1177/09246479251389204","DOIUrl":"10.1177/09246479251389204","url":null,"abstract":"<p><p>BackgroundIn real-world clinical practice, the effectiveness of medications for secondary prevention of acute myocardial infarction (AMI) is limited by low patient adherence. The lack of systematic adherence analysis inevitably distorts the evidence base for the effectiveness of these medications.ObjectiveTo investigate 1-year adherence to post-AMI therapies (statins, dual antiplatelet therapy (DAPT), and neurohormonal antagonists) using the Proportion of Days Covered (PDC) metric and evaluate its impact on treatment effectiveness through data from the Electronic Medical Information and Analytical System (EMIAS).MethodThe study included 276 patients who had undergone AMI. The follow-up period was 12 months after discharge from the hospital. Adherence was considered acceptable at PDC ≥80%. Efficacy was assessed based on endpoints for DAPT, low-density lipoprotein cholesterol (LDL-C) reduction>50% for statin therapy and left ventricular ejection fraction (LVEF) for heart failure (HF) therapy.ResultsAnnual adherence rates were critically low: 38.8% for DAPT, 37.6% for statin therapy, and 24.2% for neurohormonal therapy of HF. High adherence versus non-adherence was associated with a significant reduction in the risk of composite cardiovascular events for DAPT (p = 0.047); for statins, a reduction in LDL-C ≥50% was achieved significantly more often (31.6% vs 13.2%); and for HF patients, a significantly greater increase in LVEF was observed (55.6% vs 50.12%).ConclusionThe evidence base for the effectiveness of long-term pharmacotherapy in real-world clinical practice should be derived from the analysis of variables of interest exclusively within the treatment-adherent patient cohort.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"218-228"},"PeriodicalIF":0.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145656578","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety of fluoroquinolones in pediatric patients: Pharmacovigilance database analysis.","authors":"Olga Butranova, Yury Kustov, Sergey Zyryanov, Irina Asetskaya, Elizaveta Terehina, Vitaly Polivanov, Gleb Putsman","doi":"10.1177/09246479251398995","DOIUrl":"10.1177/09246479251398995","url":null,"abstract":"<p><p>BackgroundDue to the rising prevalence of resistant bacteria, there is a growing tendency to prescribe fluoroquinolones (FQs) to pediatric patients. Real world safety parameters of FQs in children may be studied using data of national pharmacovigilance databases. <i>The aim</i> of our study was to estimate the structure of adverse drug reactions (ADR) associated with FQs in pediatric patients.Materials and methodsretrospective study of spontaneous reports registered in Russian National Pharmacovigilance database-Automatized Information System \"Pharmacovigilance\" for the period: 1 April 2019-31 January 2024.ResultsTotal number of pediatric SRs was 280 (19.2%). Mean age was 12.1 ± 5.9 years (min - 1 day, max - 18 years), and adolescents were the most involved age group (<i>n</i> = 176, 62.9%). Mean time to ADR onset was 13.9 + 41.0 (min = 0, max = 303) days. Leading FQs were levofloxacin (49.6%, <i>n</i> = 139), ciprofloxacin (31.1%, <i>n</i> = 87), and moxifloxacin (15%, <i>n</i> = 42). Top-5 SOCs included \"Immune disorders\" (18.9%), \"Gastrointestinal disorders\" (15.0%), \"Skin and subcutaneous tissue disorders\" (14.7%), \"General disorders and administration site conditions\" (11.7%), and \"Investigations\" (7.6%). Top-5 PTs were urticaria, diarrhea, rash, arthralgia, and pruritus.ConclusionsLevofloxacin, ciprofloxacin, and moxifloxacin were the primary FQs linked to ADRs in the pediatric population. Most prevalent were allergic reactions. Children receiving FQs should be closely monitored from the start of treatment throughout their entire hospital stay and for an extended period following discharge.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"168-181"},"PeriodicalIF":0.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145545001","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of nootropics in Alzheimer's disease: An analysis of regulatory positions and drug policies in the countries of the Commonwealth of Independent States.","authors":"Elvira Grigorievna Alexandrova, Tatyana Rudolfovna Abakumova, Liliya Eugenevna Ziganshina","doi":"10.1177/09246479251410817","DOIUrl":"10.1177/09246479251410817","url":null,"abstract":"<p><p>ObjectiveTo analyse regulatory positions and drug policies of the Commonwealth of Independent States (CIS), compared to those of the EU, UK, USA i of the nootropics, used in Russia for Alzheimer's disease.MethodsWe searched E-library to reveal the list of nootropics used and studied in Russia for Alzheimer's disease. We assessed official pharmaceutical registries of nine countries for registration status of identified nootropics, 7 National Essential Medicines Lists (EML), and four clinical practice guidelines (CPG) on Alzheimer's disease. We compared the results of Russia with other countries regulatory and policy positions.ResultsE-Library searches identified 11 nootropicspiracetam, citicoline, idebenone, vinpocetine, choline alfoscerate, Cerebrolysin®, Kortexin®, ethylmethylhydroxypyridine succinate, glycine, nicergoline, nimodipine. Eight nootropic have registration for use in all CIS countries (excluding idebenone, nimodipine), four (piracetam, nimodipine, nicergoline, idebenone) - in UK, nimodipine - in the USA, and idebenone - in EU. National EMLs included: nine nootropics (Russia), 8 - Belarus and Kazakhstan, 4 - Uzbekistan, 2 - Armenia. The studied nootropic agents are not included on the WHO Model EML and on the National EML of the Kyrgyz Republic. They are not listed in the CPG for Treatment of dementia and Alzheimer's disease in the USA, the EU, and the UK. Russian CPGs for Alzheimer's disease recommend Cerebrolysin® and choline alfoscerate.ConclusionsThe studied nootropics are registered for use and listed on National EMLs of Russia, Armenia, Belarus, Kazakhstan, Uzbekistan. None is included on the WHO Model EML and the National EML of Kyrgyzstan, Only CPG of the RF recommend using two nootropics as adjuvant therapy of Alzheimer's disease, Cerebrolysin® and choline alfoscerate. CPG of the European Union, the United Kingdom, and the USA do not mention nootropics as potential treatment options for Alzheimer's disease.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"257-264"},"PeriodicalIF":0.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145859815","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adverse drug reactions to the nine-month all-oral and 18-month regimens for multidrug-resistant tuberculosis in Indonesia.","authors":"Nina Mariana, Anggi Gayatri, Indah Suci Widyahening, Budiman Bela, Neni Sawitri, Soedarsono Soedarsono, Erni Juwita Nelwan, Purwantyastuti Ascobat","doi":"10.1177/09246479251370581","DOIUrl":"10.1177/09246479251370581","url":null,"abstract":"<p><p>BackgroundThe treatment of multidrug-resistant (MDR) tuberculosis (TB) requires the long-term administration of multiple second-line drugs in combination therapy.ObjectiveWe investigated the ADRs to a 9-month all-oral regimen (i.e., pyrazinamide, ethambutol, high-dose isoniazid, levofloxacin, bedaquiline, and clofazimine) and a longer 18-months regimen (i.e., levofloxacin, bedaquiline, linezolid, clofazimine, and cycloserine) for MDR-TB during the first 4 months of treatment.MethodThe patients in this cohort study were recruited from three referral hospitals in Indonesia. The inclusion criteria were patients aged ≥18 years diagnosed with MDR-TB who received either the 9-month all-oral or 18-months regimens. We used the causality assessment categories from the WHO-Uppsala Monitoring Center.ResultsA total of 60 patients were included in this study. The ADRs included nausea and/or vomiting (48.3%), arthralgia (38.3%), prolonged QTcF interval (30.0%), among others. One case of prolonged QT interval in a grade 3 ADR was observed, in which the 18-month regimen was modified during the first 4 months of treatment.ConclusionIn the first 4 months of treatment, the predominant ADRs were nausea and/or vomiting, arthralgia, and prolonged QT interval. This study showed that active patient monitoring is needed.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":"37 2","pages":"235-241"},"PeriodicalIF":0.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147985072","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Serotonin reuptake inhibiting antidepressants: A trigger for visual snow syndrome?","authors":"Hannaa Bobat, David Healy, Dee Mangin, Jonathan Lochhead","doi":"10.1177/09246479251394585","DOIUrl":"10.1177/09246479251394585","url":null,"abstract":"<p><p>BackgroundVisual snow is an abnormal visual perception, frequently occurring in the context of visual snow syndrome. Recent literature has suggested a link with serotonin reuptake inhibiting antidepressants, but there is little research on this topic.ObjectiveWe aimed to identify cases of visual snow and visual snow syndrome linked to serotonin reuptake inhibiting antidepressants to evaluate the possibility of an association.MethodsRetrospective analysis of patient adverse event reports linking serotonin reuptake inhibiting antidepressants with visual snow or visual snow syndrome using data from RxISK.org, a global database of spontaneous reports of drug-linked adverse events. Each case was subject to a causality assessment: a RxISK score of 0-4 indicates more information is required, 5-8 a likely link and ≥9 a strong possibility of a link between the medication and the symptoms.Results24 cases were identified; 16 male and 8 female patients, with a mean age of 30 years. All had visual snow, and 10 patients (42%) had visual snow syndrome. Reports originated from 8 countries and involved 10 different drugs. Symptoms began on the drug in 14 cases (58%), after reducing the dose in 6 cases (25%), and after discontinuation in 4 cases (17%). At the time of reporting, 22 patients (92%) had stopped the suspect drug but without resolution of symptoms. The mean RxISK score was 9.5 (range 2-17).ConclusionSerotonin reuptake inhibiting antidepressants may trigger visual snow and visual snow syndrome that fails to resolve or can even worsen or emerge after stopping the drug. With usage of these medications rising worldwide, cases are likely to increase. Further research is vital to understand potential mechanisms and risk factors.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"242-248"},"PeriodicalIF":0.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13187228/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145460680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug-induced methemoglobinemia in a child with comorbidity and polypragmasia: Case report.","authors":"Alina B Strok, Maria N Kostyleva, Anna V Kostina","doi":"10.1177/09246479251405948","DOIUrl":"10.1177/09246479251405948","url":null,"abstract":"<p><p><b>Background:</b> The article describes a case of methemoglobinemia in a 4-year-old child with nephrotic syndrome with simultaneous use of therapeutic doses of three drugs that cause methemoglobinemia: lidocaine (topically), benzocaine (topically), and co-trimoxazole (systemically). An increase in the level of methemoglobin in the blood to 47.6% led to the development of respiratory failure. To correct the child's condition, high-flow oxygen therapy was performed and ascorbic acid was administered. During the day, there was a positive trend, the level of methemoglobin decreased to 1.5%. Toxicological examination of urine showed the presence of lidocaine, benzocaine, and trimethoprim. Thus, in conditions of polypragmasia in a child with comorbidity, the simultaneous use of three drugs with the potential of methemoglobinemia caused a significant increase in the level of methemoglobin and the development of respiratory failure, which required hospitalization in the intensive care unit. After 2 days, the patient's condition stabilized and he was transferred to a specialized department. As far as we know, this is the first documented case of methemoglobinemia in a child with polypragmasia.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"213-217"},"PeriodicalIF":0.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13187231/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147701783","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug-related adverse events in people with dementia - Statistical data from the FDA adverse event reporting system.","authors":"Jieyu Mao, Miyae Yamakawa, Yasushi Takeya","doi":"10.1177/09246479251385395","DOIUrl":"10.1177/09246479251385395","url":null,"abstract":"<p><p>BackgroundPeople with dementia (PwDs) are particularly vulnerable to adverse events (AEs). Recognising and understanding AEs is essential to improve patient safety.ObjectiveThis study analysed FAERS data from the past decade to identify AE symptom characteristics in PwDs.MethodsThe FAERS data (2014-2024) was reviewed, extracting reports with dementia as an indication. The reports' features were described and analysed, including k-means clustering to identify patterns.ResultsFrom 2014 to 2024, 20,913 reports related to PwDs were extracted. Consumers and health care professionals were the most common reporters. Regarding patient outcomes, 38.7% of records reported hospitalisation and 10.6% reported death. The most frequently reported AEs were death, aggression, and bradycardia. Cholinesterase inhibitors (ChEIs), antipsychotics, and anticonvulsants were frequently associated with nervous system and psychiatric disorders. K-means clustering identified four groups, with older PwDs on ChEIs experiencing cardiovascular issues, while younger PwDs on antipsychotics faced higher mortality, drug ineffectiveness, and fall risks.ConclusionsMany symptoms observed in PwDs are often attributed to ageing or disease progression, potentially obscuring their link to drug-related causes. Enhancing AE reporting across healthcare roles, promoting public awareness, conducting regular medication reviews, and providing training in early detection are vital for the safe management of dementia.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"193-200"},"PeriodicalIF":0.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145459857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}