Current drug safety最新文献

{"title":"Tubulointerstitial Nephritis in ANCA-Associated Vasculitis as a Rare Adverse Effect of Adalimumab: A Case Report.","authors":"Myriam Ayari, Maha Mtir, Ikram Mami, Lamia Rais, Sarah Ben Azouz, Hedi Douggui, Taieb Jomni","doi":"10.2174/0115748863362460250220172535","DOIUrl":"https://doi.org/10.2174/0115748863362460250220172535","url":null,"abstract":"<p><strong>Background: </strong>Patients with inflammatory disease treated with biological agents are at an increased risk of developing various adverse effects. However, little is known about the risk of nephrotoxicity, such as induced tubulointerstitial nephritis and immune-mediated inflammatory diseases involving the interstitium and renal tubule.</p><p><strong>Case report: </strong>We herein describe a case of biopsy-proven tubulointerstitial nephritis, induced by PR3-ANCA-associated vasculitis following adalimumab therapy in a patient with Crohn's disease and ankylosing spondylitis. We review the current evidence on adalimumab-induced nephrotoxicity and the potential underlying mechanisms.</p><p><strong>Conclusion: </strong>Monitoring of renal function is strongly recommended in all patients treated with adalimumab. Early diagnosis of drug-induced tubulointerstitial nephritis due to vasculitis and immediate withdrawal of the offending drug are key to renal recovery and prevention from irreversible serious organ damage.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143728924","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":"Pharmacovigilance in Geriatrics: Exploration of Etio-Clinical Profile and Severity of Adverse Drug Reactions at a Tertiary Hospital in South India.","authors":"Jerin James, Gowtham B, Kala P, Jamuna Rani, Sathyanarayanan V","doi":"10.2174/0115748863337565250312075339","DOIUrl":"https://doi.org/10.2174/0115748863337565250312075339","url":null,"abstract":"<p><strong>Background: </strong>The increasing geriatric population worldwide necessitates focused attention on medication management due to altered physiological and pharmacokinetic profiles. This study aims to explore the etio-clinical profile of Adverse Drug Reactions (ADRs) in geriatric patients and their severity, providing insights into the prevalence, severity, and contributing factors to enhance pharmacovigilance efforts.</p><p><strong>Methodology: </strong>A prospective observational study was conducted over two years, from July 2016 to September 2018, at a 1700-bed tertiary care private teaching institution in South India. ADRs were primarily collected through active surveillance, supplemented by spontaneous reporting. The collected ADRs were categorized based on gender, age, comorbidities, and the affected physiological systems to facilitate a detailed analysis. Causality assessment was performed using the WHO-UMC scale, and severity was evaluated using Hartwig and Siegel's criteria. Statistical analysis was conducted using SPSS software version 16.0, with data presented in percentages and proportions.</p><p><strong>Results: </strong>A total of 206 ADRs were documented during the study period, with 55 cases reported within the geriatric population. Among the geriatric, 32 (58.1%) were females and 23 (41.9%) were males. The causality assessment, performed using the WHO-UMC causality assessment scale, revealed that the majority of the ADRs fell into the 'likely' category, accounting for 69% (n=38) of the cases. Cutaneous manifestations were the most prevalent, observed in 38 patients. Beta-lactam antimicrobials, such as piperacillin-tazobactam, ampicillin-sulbactam, and ceftriaxone, were the most commonly involved. The severity of the ADRs was assessed using the Hartwig and Siegel severity criteria. Additionally, 48 cases were classified as mild, corresponding to levels 1 and 2 on the Hartwig and Siegel scale. Furthermore, 6 cases were classified as moderate, corresponding to levels 3 and 4 on the scale, and one was severe.</p><p><strong>Conclusion: </strong>The study highlights the critical need for vigilant pharmacovigilance in the geriatric population to prevent and manage ADRs effectively. By identifying the etio-clinical profiles of ADRs, healthcare providers can develop targeted interventions to improve therapeutic outcomes and ensure safer medication practices in this vulnerable demographic. Enhanced patient education and meticulous history-taking are pivotal in reducing the incidence of ADRs, thereby promoting better health outcomes for elderly patients.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143718211","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":"Linezolid Related Adverse Effects in Different Populations: A Practical Review.","authors":"Foroud Shahbazi","doi":"10.2174/0115748863352325250311080624","DOIUrl":"https://doi.org/10.2174/0115748863352325250311080624","url":null,"abstract":"<p><p>Linezolid, an oxazolidinone antibiotic, is used to treat gram-positive infections. However, it may also lead to serious adverse effects, including bone marrow suppression, optic neuropathy, peripheral neuropathy, hyponatremia, and lactic acidosis. This review evaluates the existing evidence concerning the adverse effects of linezolid in patients undergoing treatment with this medication, both in the short and long term. The objective of this review is to summarize the most significant adverse effects associated with linezolid. A search of PubMed was conducted for articles related to linezolid and its potential adverse effects, which include thrombocytopenia, anemia, neutropenia, lactic acidosis, optic neuropathy, and peripheral neuropathy. Thrombocytopenia frequently develops within the first two weeks of therapy, whereas anemia is more likely to manifest during prolonged treatment courses. Risk factors for linezolid-induced thrombocytopenia include elevated trough concentrations (&gt;8 mg/L), renal impairment, low body weight, and severe liver dysfunction. Patients with multidrug-resistant tuberculosis and bone infections are at an increased risk for anemia, peripheral neuropathy, and optic neuropathy. Additionally, lactic acidosis and hyponatremia can occur at any stage during treatment.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143718228","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":"Clinical Manifestations of Neuropathic Pain and the Deleterious Effects of Chemotherapeutic Agents.","authors":"Moumita Ghosh, Manodeep Chakraborty, Ananya Bhattacharjee, Nihar Bhuyan","doi":"10.2174/0115748863338537250314064501","DOIUrl":"https://doi.org/10.2174/0115748863338537250314064501","url":null,"abstract":"<p><p>Neuropathic pain is a type of pain resulting from damage or dysfunction of the nervous system. Chemotherapy-induced peripheral neurotoxicity (CIPN) is a serious complication of cancer treatment, often occurring in a dose-dependent manner. CIPN is a sensory neuropathic syndrome characterized by motor and autonomic alterations of varying intensity and duration. The lack of effective treatment options for CIPN makes it a significant clinical challenge. A variety of chemotherapeutic agents can contribute to the development of CIPN, including vinca alkaloids, platinum-based antineoplastic agents, epothilones (ixabepilone), proteasome inhibitors (bortezomib), taxanes, and immunomodulatory drugs (thalidomide), along with the genetic factors. Single nucleotide polymorphisms (SNPs) in genes, such as CEP72 and EPHA, have been linked to increased susceptibility to CIPN. The treatment options for CIPN are limited and often require careful consideration due to potential side effects and patient comorbidities. Pharmacological interventions, such as anticonvulsants, gabapentin, and pregabalin, are commonly used to manage neuropathic pain. Tricyclic antidepressants like amitriptyline and nortriptyline can be effective, but their use may be limited due to side effects. In severe cases, opioids may be considered, but they should be used cautiously due to the risk of addiction and other adverse effects. The lidocaine or capsaicin creams and patches can provide localized pain relief. The non-pharmacological interventions like physical therapy can help improve strength, balance, and mobility. Transcutaneous electrical nerve stimulation and spinal cord stimulation are invasive procedures that may be considered for severe, intractable pain. Complementary therapies and cognitive-behavioural therapy can help patients cope with pain and improve their quality of life.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143699889","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":"Self-Micro-Emulsifying Drug Delivery Systems: In-Depth Review on Enhancing Solubility and Therapeutic Efficacy of BCS Class II Drugs.","authors":"Lipanjali Badhei, Debashis Mishra, Prafulla Nandi, Himansu Bhusan Samal","doi":"10.2174/0115748863354153250225074632","DOIUrl":"https://doi.org/10.2174/0115748863354153250225074632","url":null,"abstract":"<p><p>The development of self-micro-emulsifying drug delivery system (SMEDDS) has revolutionized pharmaceutical formulation by providing an advanced method of increasing medication bioavailability and therapeutic effectiveness. The systems encapsulate hydrophobic drugs in nanoscale droplets and enable them to be soluble and stable in water via the spontaneous formation of oil in water emulsions when gently agitated. Using SMEDDS, pharmaceuticals can be extended to offer enhanced therapeutic potential, and new medicines can be developed that were previously impossible to develop due to their bioavailability limitations. They are versatile and user-friendly, helping to reduce pill burden and improve comfort, which can support better compliance and outcomes. Challenges such as formulation stability and regulatory compliance have been identified in various literature as hurdles for adopting SMEDDS in clinical applications. To address these gaps, this work covers multiple components used in SMEDDS, their classification, formulation methods, characterization, and their advantages and disadvantages. In order to expedite the application of Self-Emulsifying Drug Delivery Systems (SEDDS) in pharmaceutical research, it offers comprehensive statistics on all the necessary aspects of self-micro-emulsifying formulations. Several emulsion-based technologies suitable for edible delivery methods in the drug, cosmetics, and other industries are described. These consist of filled hydrogel particles, solid lipid particles, multiple emulsions, multilayer emulsions, and traditional emulsions.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143718214","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":"Certolizumab-Induced Urticarial Vasculitis: A Case Report.","authors":"Bouraoui Ouni, Ferdaous Chahed, Raoudha Slim, Bahaeddine Dridi, Malek Sassi, Badereddine Sriha, Nedia Ghariani, Nesrine Bensayed, Neila Fathallah","doi":"10.2174/0115748863356947250302165303","DOIUrl":"https://doi.org/10.2174/0115748863356947250302165303","url":null,"abstract":"<p><strong>Introduction: </strong>Certolizumab (CZ) is a tumour necrosis factor-α (TNF-α) blocking agent with excellent efficiency in rheumatoid arthritis (RA). Urticarial vasculitis (UV) induced by CZ is a rare side effect. Herein, we describe a patient with UV probably induced by CZ therapy.</p><p><strong>Case report: </strong>A 33-year-old female with RA was treated with methotrexate and corticosteroids, which resulted in no improvement. The patient was switched to CZ, and one week later, the patient developed urticaria (erythematous and edematous plaques). The diagnosis of urticarial vasculitis related to CZ was suspected. The results of microbiological and autoimmunity tests ruled out other causes of vasculitis. The diagnosis of CZ-induced-UV was retained (Naranjo's score: 5). CZ was withdrawn, which led to rapid resolution of skin lesions.</p><p><strong>Conclusion: </strong>With the increasing use of CZ, physicians should be aware of the possibility of UV associated with CZ.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143718227","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":"Revealing the Future of Pharmacovigilance in Precision Pharmaceutical Monitoring.","authors":"Vishnu Mittal, Anjali Sharma","doi":"10.2174/0115748863355987250223072145","DOIUrl":"https://doi.org/10.2174/0115748863355987250223072145","url":null,"abstract":"<p><p>The growing popularity of personalized medicine presents new hazards and difficulties for pharmacovigilance. This implies that it needs to modify its current approach. This research examines how drug safety monitoring for certain medications evolves over time. We briefly discuss the connection between meticulous pharmacovigilance procedures and adaptable treatment approaches. We describe how pharmacogenetics may be used to make drugs safer and how genetic testing may be used to forecast a drug's potential side effects. With an emphasis on post-marketing monitoring in phase IV, we address shortcomings of research on pre-marketing and the need for a comprehensive strategy for medication safety. The significance of pharmacogenetics in reducing risk before exposure and the need to reconsider pharmacoepidemiological techniques for monitoring outcomes after exposure are discussed in the study. We emphasize the significance of including genetic patient-specific profiles in publications related to tailored therapy and the use of state-of-the-art computer techniques for data processing. We also discuss privacy, ethical, and data security issues that arise with precision medicine, emphasizing the consequences for patient consent and data management.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603848","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":"Managing Opioid Tolerance: Balancing Pain Relief and Tackling Addiction.","authors":"Astha Mehta, Anunav Ashish, Shubham Thakur","doi":"10.2174/0115748863365955250305181057","DOIUrl":"https://doi.org/10.2174/0115748863365955250305181057","url":null,"abstract":"<p><p>This editorial discusses opioid tolerance, a growing challenge in managing pain in chronic patients. With time, overuse of opioids causes less sensitivity and responsiveness of opioid receptors and leads to higher doses of opioids for the same level of pain management. Due to this, it increases the risk of side effects, such as opioid addiction, respiratory issues, and overdose. The editorial highlights the relationship between opioid use disorder (OUD) and opioid tolerance and discusses the difficulty faced by patients and doctors during opioid tolerance. To address these challenges, a multimodal pain management approach, including physical therapies, cognitive-behavioural therapy, and opioid rotation, is proposed to enhance pain relief while reducing dependency. Policy changes and further research into alternative pain management methods and mechanisms of opioid tolerance in patients are needed to improve and limit the opioid crisis effectively.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603817","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":"Efficacy and Safety Profile of Suvorexant for the Treatment of Insomnia.","authors":"Ariba Sabat, Aakriti Garg, Mohd Ashif Khan","doi":"10.2174/0115748863337982250212111648","DOIUrl":"https://doi.org/10.2174/0115748863337982250212111648","url":null,"abstract":"<p><p>Insomnia is becoming a concern in general practice as it affects around 30% of adults. It is a sleep disorder characterized by trouble getting asleep, staying asleep, waking up early, and difficulty falling back to sleep. The most commonly used hypnotics, such as benzodiazepines, Z drugs, etc, are associated with various issues, including psychomotor and cognitive impairment. Dual orexin receptor antagonists are an emerging class of hypnotics used to treat insomnia. Suvorexant is a first-in-class dual orexin receptor antagonist approved by the US FDA in 2014 for the treatment of insomnia. Suvorexant is administered orally, absorbed well, metabolized by cytochrome P450 enzyme, and excreted through feces. Some common adverse effects of suvorexant are headache, somnolence, dizziness, diarrhea, cough, abnormal dreams, and upper respiratory tract infection. The current paper aimed to review the pharmacokinetics and pharmacodynamic properties of suvorexant.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540134","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":"A Biochemical Investigation of the Prevalence of Hypercalcemia and Thiazide-Related Hypercalcemia in Patients.","authors":"Shariq Rashid Masoodi, Moomin Hussain Bhat, Imtiyaz Ahmed Najar, Mosin S Khan, Javaid Rasool Bhat, Sazal Patyar, Poonam Arora, Manish Kumar","doi":"10.2174/0115748863317871241015060209","DOIUrl":"https://doi.org/10.2174/0115748863317871241015060209","url":null,"abstract":"<p><strong>Objective: </strong>Hypercalcemia allied with thiazide diuretics is a widely acknowledged clinical presentation. Hence, the purpose of this investigation was to ascertain the prevalence of hypercalcemia and hypercalcemia linked to thiazides and to evaluate serum phosphorous, 25- hydroxyvitamin D, and parathyroid hormone (PTH).</p><p><strong>Methods: </strong>This prospective, cross-sectional research study involved all patients, including outpatients, and was conducted over a 12-month period. Between December 2017 and December 2018, an aggregate of 373 patients were enrolled. All patients with hypercalcemia (albumincorrected serum calcium > 10.8 mg/dL) had their medical information put on a proforma, together with the results of any tests (such as parathyroid hormone (PTH), 25-hydroxyvitamin D, and serum phosphorus).</p><p><strong>Results: </strong>Out of 373 subjects, 7 (2%) were hypercalcemic. The mean corrected calcium levels in the normo-calcemic group were 9.46 ± 0.60 mg/dL (95% CI, 9.4 - 9.5), and that in the hypercalcemic group were 11.68 ± 0.82 mg/dL (95% CI, 10.9 - 12.4). Of the seven cases of hypercalcemia, 2 patients (28.6%) had thiazide-associated hypercalcemia (TAH) along with primary hyperparathyroidism (PHPT). Of the remaining 5 hypercalcemia patients, two more had PHPT, and one (14.3%) had hypervitaminosis D, whereas no cause was mentioned in the remaining 2 patients. Among the 4 PHPT patients, corrected calcium was slightly higher in those with TAH vs those without TAH, though the difference was statistically insignificant (11.32 ± 0.43 vs 11.14 ± 0.39 mg/dL; P > 0.7).</p><p><strong>Conclusion: </strong>TAH is the second primary cause of asymptomatic hypercalcemia after PHPT. Thus, close coordination between the clinicians, pharmacology, pharmacovigilance, and the biochemistry department may help in identifying these cases.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143514700","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}