Current drug safety最新文献

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Enhancing Patient Safety: Patterns of Adverse Drug Reaction Reporting in a Tertiary Care Hospital in Eastern India: A Record-based Retrospective Study. 加强患者安全:印度东部三级医院药物不良反应报告模式:基于记录的回顾性研究。
IF 1.2
Current drug safety Pub Date : 2026-08-03 DOI: 10.2174/0115748863471075260724094945
Prasanjit Das, Alapan Das, Bisweswar Ojha, Deepasree Sukumaran, Soumitra Mandal
{"title":"Enhancing Patient Safety: Patterns of Adverse Drug Reaction Reporting in a Tertiary Care Hospital in Eastern India: A Record-based Retrospective Study.","authors":"Prasanjit Das, Alapan Das, Bisweswar Ojha, Deepasree Sukumaran, Soumitra Mandal","doi":"10.2174/0115748863471075260724094945","DOIUrl":"https://doi.org/10.2174/0115748863471075260724094945","url":null,"abstract":"<p><strong>Background: </strong>Adverse drug reactions (ADRs) are a significant cause of increased morbidity and mortality, prolonged hospitalisation, and financial burden on patients. Regular ADR monitoring helps formulate strategies for the safe and effective use of medicines in healthcare settings. This study was conducted to assess the trends in ADR reporting along with their various aspects.</p><p><strong>Methods: </strong>This record-based observational study was conducted at the ADR Monitoring Centre of our healthcare facility. ADRs reported from April to September 2023 were analysed. The WHO-UMC scale, Modified Hartwig Severity Assessment Scale and Modified Schumock and Thornton Scale were used to assess the causality, severity, and preventability of ADRs, respectively. Descriptive statistics were used for the analyses.</p><p><strong>Results: </strong>A total of 146 adverse drug reactions (ADRs) were reported during the study period. Of these, 68.49% of the ADRs were reported from the Department of Psychiatry. Female patients accounted for 53.42% of reported ADRs. Neurological system involvement was observed in 32.9% of the ADRs. Escitalopram was the most frequently implicated drug. Causality assessment revealed that 63.01% of ADRs were possible. Meanwhile, 83% of the ADRs were mild in severity, and a total of five ADRs were found to be serious in this study, none of which were fatal. Furthermore, 39.73% of the ADRs were classified as probably preventable.</p><p><strong>Discussion: </strong>The predominance of neuropsychiatric ADRs observed in this study may reflect both prescribing patterns and improved recognition of CNS-related adverse effects in psychiatric practice. These findings also highlight the importance of strengthening ADR reporting practices across all departments.</p><p><strong>Conclusion: </strong>The ADR reporting pattern observed in this newly established tertiary healthcare facility in eastern India may help increase physicians' awareness of the importance of timely ADR reporting and support their clinical decision-making process.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148808385","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}
引用次数: 0
Dapsone-Induced Photosensitivity: A Rare and Overlooked Clinical Dilemma. 氨苯砜诱导的光敏:一个罕见的和被忽视的临床困境。
IF 1.2
Current drug safety Pub Date : 2026-07-27 DOI: 10.2174/0115748863490734260714102047
Akshay Sankar Peethambaran
{"title":"Dapsone-Induced Photosensitivity: A Rare and Overlooked Clinical Dilemma.","authors":"Akshay Sankar Peethambaran","doi":"10.2174/0115748863490734260714102047","DOIUrl":"https://doi.org/10.2174/0115748863490734260714102047","url":null,"abstract":"<p><strong>Introduction: </strong>Dapsone (4,4'- diamino diphenyl sulfone, DDS) is an antimicrobial sulfonamide used for non-dermatological and dermatological disorders. Dapsone has been associated with a wide range of cutaneous adverse effects, with photosensitivity being an unusual side effect.</p><p><strong>Case presentation: </strong>A case of dapsone-induced photosensitivity was reported in a patient with lepromatous leprosy. A 46-year-old male patient complained of redness and scaling, with itching over his face, nape, the flexural aspect of his neck, and bilateral upper and lower limbs, during the second month of multidrug multibacillary therapy. Examining the face, neck, and upper and lower limbs revealed erythematous scaly plaques with crusting and fissuring. Dapsone-induced photosensitivity was suspected, and the drug was stopped immediately. The patient was started on 0.5 mg/kg of prednisolone, antihistamines, and sunscreen. After improving symptomatically, the patient was discharged from the hospital and started on multidrug multibacillary therapy without dapsone.</p><p><strong>Conclusion: </strong>Although it is uncommon, dapsone-induced photosensitivity should be taken into account when patients exhibit photodermatoses while receiving treatment. Morbidity and unnecessary regimen discontinuation can be avoided with early detection followed by prompt care. This case emphasizes how crucial it is for physicians to be aware of this unusual side effect.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148683731","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}
引用次数: 0
Investigating the Therapeutic Potential of a Polyherbal Formulation in Progesterone-induced Obesity: Insights from Preclinical Studies. 研究一种复方黄体酮诱导肥胖的治疗潜力:来自临床前研究的见解。
IF 1.2
Current drug safety Pub Date : 2026-07-27 DOI: 10.2174/0115748863396631251005190202
Devendra Shriram Shirode, Aishwarya Sambhaji Patil, Deepak S Khobragade, Sunil Kumar Kadiri, Prashant Tiwari
{"title":"Investigating the Therapeutic Potential of a Polyherbal Formulation in Progesterone-induced Obesity: Insights from Preclinical Studies.","authors":"Devendra Shriram Shirode, Aishwarya Sambhaji Patil, Deepak S Khobragade, Sunil Kumar Kadiri, Prashant Tiwari","doi":"10.2174/0115748863396631251005190202","DOIUrl":"https://doi.org/10.2174/0115748863396631251005190202","url":null,"abstract":"<p><strong>Introduction: </strong>Metabolic disorders have grown more common, with obesity representing a significant chronic illness that leads to various severe health complications. The Obesity Atlas 2022 predicts one billion obese people by 2030. Contributors to obesity encompass heightened oxidative stress, hyperlipidemia, hunger enhancement, fat accumulation, insulin resistance, and diminished caloric expenditure. Numerous synthetic interventions for obesity are accessible today ; nonetheless, they frequently entail detrimental side effects. This research aimed to investigate the formulation of a prospective anti-obesity drug derived from plant origins.</p><p><strong>Methods: </strong>The anti-obesity effectiveness of a polyherbal formulation, derived from the ethanolic extract of both Hugonia mystax and Blumea lacera in a 1:1 ratio, was assessed in female mice with progesterone-induced obesity.</p><p><strong>Results: </strong>The preliminary phytochemical screening of the formulation specifies the presence of phenolic acids, flavonoids, and tannins. In accordance to OECD recommendations, 200 mg/kg and 400 mg/kg were designated after performing acute oral toxicity assessment as a low dose and high dose. During the study, body weight, BMI, abdomen circumference, glucose levels, lipid profile, SGOT, SGPT, atherogenic index, lipid peroxidation (LPO), and glutathione (GSH) levels were evaluated in all groups. The treatment markedly corrected the abnormal levels of these parameters and dramatically restored GSH levels.</p><p><strong>Discussion: </strong>Metabolic disorders, especially obesity, are increasing globally. Synthetic therapies have negative consequences; therefore, exploration of plant substitutes is encouraged A polyherbal extract of Hugonia mystax and Blumea lacera has shown significant anti-obesity properties in mice. It restored biochemical parameters, likely due to phytochemicals such as polyphenols. Histological examination validated its therapeutic efficacy.</p><p><strong>Conclusion: </strong>The formulation's efficacy in addressing obesity is likely attributable to the presence of polyphenols, saponins, and terpenoids. Histopathological examination of hepatic and adipose tissues further corroborated the anti-obesity efficacy of the polyherbal formulation. Future research will focus on isolating and identifying the active chemicals in both plants to better understand their composition.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148683726","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}
引用次数: 0
Clinical Experience with Quintuple Non-Insulin Drug Therapy in Suboptimally Controlled Type 2 Diabetes. 非胰岛素药物五联治疗控制不佳的2型糖尿病的临床经验
IF 1.2
Current drug safety Pub Date : 2026-07-25 DOI: 10.2174/0115748863485481260722093116
Georgios S Papaetis, Costas A Christophi, Andriana M Till, Anastasia Papapostolou, Michalis K Picolos
{"title":"Clinical Experience with Quintuple Non-Insulin Drug Therapy in Suboptimally Controlled Type 2 Diabetes.","authors":"Georgios S Papaetis, Costas A Christophi, Andriana M Till, Anastasia Papapostolou, Michalis K Picolos","doi":"10.2174/0115748863485481260722093116","DOIUrl":"https://doi.org/10.2174/0115748863485481260722093116","url":null,"abstract":"<p><strong>Introduction: </strong>Current evidence for individuals experiencing Type 2 Diabetes (T2D), who refuse insulin treatment and are given five non-insulin antidiabetic drug combinations, is scarce.</p><p><strong>Methods: </strong>We conducted a retrospective observational study to investigate the prevalence of quintuple non-insulin drug regimens during a 12-month period, in patients with suboptimally controlled T2D who refuse insulin therapy.</p><p><strong>Results: </strong>1463 individuals with T2D were assessed during the course of the investigation. Forty patients (2.7%) satisfied the eligibility criteria and were included. The mean therapeutic period was 35.5 ± 29.2 months, and the mean A1C was 7.5± 1.0%. The majority of patients received pioglitazone as the fifth choice to background quadruple regimens (70%). The mean decrease in A1C levels was 0.82 ± 0.99% compared to baseline indices without notable side effects and safety concerns (p < 0.001). Fear of starting insulin was the major reason for rejecting insulin therapy.</p><p><strong>Discussion: </strong>Despite the limitations inherent to its retrospective design, this study shows that five non-insulin drug combinations can be considered a possible therapeutic option for this difficultto-treat group of patients, at least until they are convinced to start and maintain insulin therapy.</p><p><strong>Conclusion: </strong>The prevalence of individuals with T2D treated with quintuple non-insulin drug regimens was 2.7% without any notable side effects or safety concerns. In patients who refuse insulin therapy, these combinations can be taken into consideration according to the characteristics of every individual and carefully evaluated for their safety and effectiveness.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148599812","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}
引用次数: 0
Optimizing Management of Newly Diagnosed T2DM Mellitus Through Combination Therapy: Efficacy, Safety, and Individualized Care Approaches. 通过联合治疗优化新诊断T2DM的管理:有效性、安全性和个体化护理方法。
IF 1.2
Current drug safety Pub Date : 2026-07-24 DOI: 10.2174/0115748863463809260715073035
Ahmad Alam, Sulthan Al Rashid, Rajkapoor Balasubramanian, Naina Mohamed Pakkir Maideen, Palanisamy Amirthalingam
{"title":"Optimizing Management of Newly Diagnosed T2DM Mellitus Through Combination Therapy: Efficacy, Safety, and Individualized Care Approaches.","authors":"Ahmad Alam, Sulthan Al Rashid, Rajkapoor Balasubramanian, Naina Mohamed Pakkir Maideen, Palanisamy Amirthalingam","doi":"10.2174/0115748863463809260715073035","DOIUrl":"https://doi.org/10.2174/0115748863463809260715073035","url":null,"abstract":"<p><strong>Background: </strong>Prolonged hyperglycemia, increasing beta-cell loss, and therapeutic inertia are common outcomes of the conventional stepwise approach to treating newly diagnosed type 2 diabetes mellitus (T2DM). In order to quickly achieve glycemic objectives and alter the course of the disease, recent guidelines recommend early combination therapy. However, putting this paradigm into practice necessitates careful assessment of diverse pharmacological profiles. The goal of this review is to assess the available data on early combination therapy for newly diagnosed T2DM, with an emphasis on safety profiles, clinical efficacy, and patient care strategies.</p><p><strong>Methods: </strong>Recent clinical trials (RCTs), meta-analyses, and significant international guidelines evaluating initial triple therapy against sequential monotherapy were identified by searching online databases such as Web of Science, PubMed, and Scopus. Medical Subject Headings (MeSH) terms such as \"triple combination therapy,\" \"newly diagnosed diabetes mellitus,\" \"T2DM,\" and \"cost-effectiveness\" were included in the search strategy. RCTs, real-world observational studies, and health-economic evaluations were all included in the review.</p><p><strong>Results: </strong>In terms of achieving and sustaining HbA1c objectives, promoting weight loss, and preserving beta-cell activity, early combination therapy shows higher efficacy. Additionally, compared with earlier secretagogue-based regimens, contemporary combinations have superior safety profiles, reducing the incidence of hypoglycemia and adverse effects. Importantly, the choice of agents needs to be customized. The optimal therapy combination is determined by patient- specific factors, such as the presence of atherosclerotic cardiovascular disease (ASCVD), heart failure, chronic kidney disease (CKD), baseline HbA1c, weight management objectives, and socioeconomic factors.</p><p><strong>Conclusion: </strong>A proactive transition from sequential add-on therapy to initial combination regimens is necessary to optimize the management of newly diagnosed T2DM. Clinicians can optimize cardiometabolic benefits, guarantee long-term safety, and enhance overall quality of life by using a patient-centered, customized approach.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148599872","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}
引用次数: 0
Pharmacists' Role in Ensuring Safe Handling and Administration of Anticancer Medications in India. 药剂师在确保安全处理和管理抗癌药物在印度的作用。
IF 1.2
Current drug safety Pub Date : 2026-07-22 DOI: 10.2174/0115748863433931260707115559
M V Neethu, Vikas Pandey, Mohana Lakshmi, C K Ashok Kumar, Palakurthi Yanadaiah, Hemraj Singh Rajput, K Anjali, Sagar Pamu
{"title":"Pharmacists' Role in Ensuring Safe Handling and Administration of Anticancer Medications in India.","authors":"M V Neethu, Vikas Pandey, Mohana Lakshmi, C K Ashok Kumar, Palakurthi Yanadaiah, Hemraj Singh Rajput, K Anjali, Sagar Pamu","doi":"10.2174/0115748863433931260707115559","DOIUrl":"https://doi.org/10.2174/0115748863433931260707115559","url":null,"abstract":"<p><p>Pharmacists play a significant role in oncology with respect to the safe handling and administration of anti-cancer drugs. This comprehensive review analyses pharmacists' roles, emphasising adherence to national and international safety standards and the implementation of institutional programs for protocols, training, and certification. Pharmacists will aid in the formulation and adjustment of chemotherapy medications through Personal Protective Equipment kits and working practices. Among administration methods, intravenous chemotherapy, oral anticancer agents, and special routes, such as intrathecal, can be used. Other notable responsibilities of pharmacists' work are medication safety, occupational exposure risk, and pharmacovigilance. Pharmacists can gain practical insights through case studies and possibly help prevent and control errors by implementing systemic strategies. Pharmacists are also involved in counselling and teaching patients for treatment, managing side effects, and other policies that enhance compliance. This review provides valuable insights into interprofessional collaboration to improve patient safety and achieve optimal outcomes. Emerging technologies and innovations are having a growing impact on medication management, and pharmacists have been recognised as playing a vital role in ensuring safe adoption in oncology practice. Continuous education and professional development enable pharmacists to stay up to date on the latest advancements, providing the best possible care. This review discusses the essential contributions pharmacists make to the oncology department by improving the care, safety, and efficacy of anticancer treatment, demonstrating their commitment to excellence and adaptability in healthcare settings.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148599953","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}
引用次数: 0
Fluoroquinolone-induced liver injury and pharmacists' interventions in pneumonia: a case report and clinical pharmacist intervention. 氟喹诺酮类药物致肺炎肝损伤及药师干预1例及临床药师干预
IF 1.2
Current drug safety Pub Date : 2026-07-16 DOI: 10.2174/0115748863428609251111141726
Man Lv, Junmin Zheng, Youping Zhang, Xiaoshuang Wang, Jinmin Shi, Ping Long
{"title":"Fluoroquinolone-induced liver injury and pharmacists' interventions in pneumonia: a case report and clinical pharmacist intervention.","authors":"Man Lv, Junmin Zheng, Youping Zhang, Xiaoshuang Wang, Jinmin Shi, Ping Long","doi":"10.2174/0115748863428609251111141726","DOIUrl":"https://doi.org/10.2174/0115748863428609251111141726","url":null,"abstract":"<p><p>Background The diagnosis of drug-induced liver injury (DILI) is difficult due to insufficient awareness of DILI and the lack of specific objective diagnostic tests. The importance of pharmacists' care during hospitalization is underestimated. Our aim is to review the clinical features of fluoroquinolone-induced liver injury and to highlight the importance of pharmacists' intervention in fluoroquinolone-induced liver injury. . Case presentation: An 81-year-old Chinese man was admitted to hospital for the treatment of community-acquired pneumonia. After admission, he developed chronic subdural hematoma as his condition deteriorated, followed by intracranial infection after the cranial trepanation. On day 15, the patient still presented with fever and altered consciousness. Moxifloxacin (IV, 400 mg QD) was administered as the pulmonary infection became worse. Elevated liver enzymes were then observed with alanine aminotransferase (ALT) rising from 27 U/L to 387 U/L after the three-day use of moxifloxacin. With the help of pharmacists' interventions, drug-induced liver injury was identified. Moxifloxacin was discontinued immediately and replaced with meropenem (IV, 1g, Q8h). Within another 7 days, the patient's fever subsided, liver function normalized, and consciousness improved. He was successfully discharged from the hospital 30 days after admission. Written informed consent was obtained from the patient. Ethics approval was waived by the Institutional Review Board of Taikang Tongji (Wuhan) Hospital. Conclusions: Fluoroquinolone-induced liver injury are rare but can be lethal. Pharmacists' interventions enable collaborative decision-making and can help improve the management in fluoroquinolone-induced liver injury.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148520196","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}
引用次数: 0
Recognizing Subtle Neurological Adverse Effects of Fluoroquinolones: A Case Report of Isolated Dysarthria. 氟喹诺酮类药物对神经系统的不良反应:一例孤立构音障碍。
IF 1.2
Current drug safety Pub Date : 2026-07-03 DOI: 10.2174/0115748863481172260619073442
Benedetto Caroleo, Gianmarco Marcianò, Giuseppe Bertucci, Marica Caruso, Caterina Di Masi, Giovanni Antonio Fiorino, Remigio Iacopino, Francesco Marra, Marilena Mitra, Elisabetta Pedace, Vincenzo Rania, Domenica Scumaci, Luca Gallelli
{"title":"Recognizing Subtle Neurological Adverse Effects of Fluoroquinolones: A Case Report of Isolated Dysarthria.","authors":"Benedetto Caroleo, Gianmarco Marcianò, Giuseppe Bertucci, Marica Caruso, Caterina Di Masi, Giovanni Antonio Fiorino, Remigio Iacopino, Francesco Marra, Marilena Mitra, Elisabetta Pedace, Vincenzo Rania, Domenica Scumaci, Luca Gallelli","doi":"10.2174/0115748863481172260619073442","DOIUrl":"https://doi.org/10.2174/0115748863481172260619073442","url":null,"abstract":"<p><strong>Background: </strong>Fluoroquinolones may have negative effects on the central nervous system; isolated dysarthria has not been thoroughly described.</p><p><strong>Case: </strong>Piperacillin/tazobactam and high-dose levofloxacin were used to treat a severe case of Legionella pneumophila pneumonia in a 55-year-old man with diabetes and temporary renal failure who was admitted to the hospital. On the eighth day of treatment, he experienced sudden dysarthria without any additional neurological impairment. Magnetic resonance angiography and brain magnetic resonance imaging results were negative. After levofloxacin was stopped two days later and replaced with azithromycin, the patient's dysarthria completely disappeared, and he was discharged on azithromycin (500 mg for 11 days). The Naranjo score (likely adverse reaction) was 6.</p><p><strong>Conclusion: </strong>This case report highlights the importance of quickly identifying even mild neurological problems in fluoroquinolone-treated patients, especially when risk factors are present. In a broader sense, it upholds the concepts of patient safety and therapeutic appropriateness, which state that drugs should only be used when necessary and should be stopped immediately if they have negative side effects. In this regard, strict adherence to the current regulatory cautions about fluoroquinolones is necessary.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148395897","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}
引用次数: 0
Explainable Artificial Intelligence in Pharmacovigilance and Drug Safety: A Systematic Review of Enhancing Transparency and Regulatory Acceptance. 可解释的人工智能在药物警戒和药物安全:提高透明度和监管接受度的系统回顾。
IF 1.2
Current drug safety Pub Date : 2026-06-24 DOI: 10.2174/0115748863467208260529094811
Virendra S Gomase, Shenbagavel Vairachilai, Rupali Sharma, Suchita P Dhamane, Satish Sardana, Bijith Marakarkandy, Sandeep Kelkar
{"title":"Explainable Artificial Intelligence in Pharmacovigilance and Drug Safety: A Systematic Review of Enhancing Transparency and Regulatory Acceptance.","authors":"Virendra S Gomase, Shenbagavel Vairachilai, Rupali Sharma, Suchita P Dhamane, Satish Sardana, Bijith Marakarkandy, Sandeep Kelkar","doi":"10.2174/0115748863467208260529094811","DOIUrl":"https://doi.org/10.2174/0115748863467208260529094811","url":null,"abstract":"<p><strong>Introduction: </strong>Explainable Artificial Intelligence (XAI) is rapidly transforming drug safety assessment by making complex AI models interpretable, transparent, and trustworthy for clinicians, healthcare regulators, and patients. This study emphasizes recent advances in the methodologies of XAI, including rule-based, post hoc, and hybrid models, and assesses the effectiveness of these approaches in pharmacovigilance and drug discovery.</p><p><strong>Method: </strong>This paper evaluates the state-of-the-art techniques in XAI methods, such as methodbased or rule-based approaches, post-hoc explanation methods, and hybrid methods in general, used in drug safety and pharmaceutical-related research and applications. The role and treatment of explainability in AI in the EU AI Act and EU MDR regulations will also be discussed in this paper.</p><p><strong>Results: </strong>Integration of XAI into clinical prediction systems (CPS) evaluation will increase the level and quality of transparency and error identification, and clinician trust, although with a trade-off between interpretation and accuracy within prediction tasks. There is a shift towards greater focus on transparency and human evaluation mentioned within regulatory frameworks, although there is no standardization with respect to clinical prediction systems (CPS) evaluation and validation of XAI.</p><p><strong>Discussion: </strong>Emerging technologies emphasize the importance of clinician-centric design, personalized and causal inference-based explanations, and the integration of technical aspects and clinician feedback. Large research gaps are present in the standardization of evaluation criteria, ethical integration, and real-world clinically valid XAI systems.</p><p><strong>Conclusion: </strong>In clinical applications associated with drug safety, emerging areas of research should be targeted towards collaborations, evaluations, and XAI design adaptable to meeting growing demands for operation, acceptability, and patient safety.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148344097","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}
引用次数: 0
Intravenous Methylcobalamin-Induced Anaphylactic Shock: A Case Report. 静脉注射甲钴胺诱发过敏性休克1例。
IF 1.2
Current drug safety Pub Date : 2026-06-12 DOI: 10.2174/0115748863468407260605062252
Alaimagal Ravi, Lalitha R, Sam Johnson Udaya Chander J
{"title":"Intravenous Methylcobalamin-Induced Anaphylactic Shock: A Case Report.","authors":"Alaimagal Ravi, Lalitha R, Sam Johnson Udaya Chander J","doi":"10.2174/0115748863468407260605062252","DOIUrl":"https://doi.org/10.2174/0115748863468407260605062252","url":null,"abstract":"<p><strong>Background: </strong>Methylcobalamin is a naturally occurring, active form of Vitamin B12. Vitamin B12 is essential for the growth and development of healthy nerves and red blood cell production. Usually, the requirement of vitamin B12 is increased in thyrotoxicosis due to increased utilization and accelerated turnover imposed by increased metabolism. Vitamin B12 is generally well-tolerated and widely used in clinical settings. Parenteral vitamin B12 treatment in hospitalized patients is considered an effective therapy regardless of its etiology.</p><p><strong>Case presentation: </strong>Herein, we report the case of a 26-year-old female patient admitted to the Obstetrics and Gynaecology department. She received a slow intravenous methylcobalamin injection on the 4th day of admission for his complaints. Then, she was administered with 2nd dose of intravenous methylcobalamin, after which she developed anaphylactic shock immediately. To address these serious adverse effects, the patient was administered Critical care with cardiopulmonary resuscitation without further delay. The patient had a spontaneous return of circulation within a few minutes of high-quality cardiopulmonary resuscitation. After treatment, the patient recovered and was discharged from the hospital.</p><p><strong>Conclusion: </strong>Anaphylactic shock, after slow intravenous methylcobalamin injection, is an uncommon but potentially serious adverse effect. The purpose of this case report is to highlight the importance of this rare but serious life-threatening adverse effect. To our knowledge, this is the first reported case of intravenous methylcobalamin-induced anaphylactic shock. Physicians and healthcare teams should be cautious while administering methylcobalamin to patients, especially via the intravenous route.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148263707","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}
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