Current Drug Safety[JOURNAL]
Sun
200 papers
Explainable Artificial Intelligence in Pharmacovigilance and Drug Safety: A Systematic Review of Enhancing Transparency and Regulatory Acceptance.
Gomase VS, Vairachilai S, Sharma R … +4 more , Dhamane SP, Sardana S, Marakarkandy B, Kelkar S
Curr Drug Saf · 2026 Jun · PMID 42367118 · Publisher ↗
INTRODUCTION: Explainable Artificial Intelligence (XAI) is rapidly transforming drug safety assessment by making complex AI models interpretable, transparent, and trustworthy for clinicians, healthcare regulators, and pa...
INTRODUCTION: 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. METHOD: 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. RESULTS: 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. DISCUSSION: 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. CONCLUSION: 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.
Intravenous Methylcobalamin-Induced Anaphylactic Shock: A Case Report.
Ravi A, R L, J SJUC
Curr Drug Saf · 2026 Jun · PMID 42304930 · Publisher ↗
BACKGROUND: 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 vitam...
BACKGROUND: 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. CASE PRESENTATION: 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. CONCLUSION: 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.
Nasal Bleeding as a Potential Side Effect of Omega-3 Fatty Acids: A Case Report.
Abdul-Nabi ZN
Curr Drug Saf · 2026 Apr · PMID 42298999 · Publisher ↗
BACKGROUND: Omega-3 fatty acids (omega-3 FAs) have been studied for the potential treatment of Atopic Dermatitis (AD). Dietary supplementation with omega-3 FAs may help in reducing AD symptoms, including the severity of...
BACKGROUND: Omega-3 fatty acids (omega-3 FAs) have been studied for the potential treatment of Atopic Dermatitis (AD). Dietary supplementation with omega-3 FAs may help in reducing AD symptoms, including the severity of lesions, inflammation, dryness, and pruritus. Nevertheless, because of their antiplatelet action, more cautious use of these supplements has been recommended in patients who have an invasive procedure or who are receiving antiplatelet or anticoagulant therapy. CASE PRESENTATION: An 18-year-old male patient with AD self-medicated with 1 gram of overthe-counter omega-3 fatty acid orally once daily for 4 weeks. Over this time, he had ten episodes of epistaxis. Baseline coagulation parameters, such as prothrombin time, activated partial thromboplastin time, and platelet count, were also normal. The patient was not on medications affecting the hemostatic process, nor were there any previous polyps or other structural nasal disorders. CONCLUSIONS: The potential of omega-3 FA supplementation to increase risk of bleeding, even at typical doses used in clinical trials, should be considered as demonstrated in this case.
Pharmacovigilance Analysis of Azelastine-Related Adverse Events: Insights from the FDA FAERS Database (2006-2024).
Liang F, Chen L, Hu C … +3 more , Lu R, He C, Yu G
Curr Drug Saf · 2026 Jun · PMID 42253253 · Publisher ↗
BACKGROUND: Azelastine is widely used in the treatment of allergic rhinitis, and it is necessary to gain insight into the true extent of adverse events (AEs) associated with it. METHODS: This pharmacovigilance study was...
BACKGROUND: Azelastine is widely used in the treatment of allergic rhinitis, and it is necessary to gain insight into the true extent of adverse events (AEs) associated with it. METHODS: This pharmacovigilance study was based on an analysis of reports from the FDA Adverse Event Reporting System (FAERS) for the period January 1, 2006, to December 31, 2024. AEs of drugs were compared using the Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPN), and Multi-item Gamma Poisson Shrinkage (MGPS). RESULTS: The number of AE occurrences in Respiratory, thoracic, and mediastinal disorders and Product issues was high. There is a significant difference in the proportion of occurrence between men and women. All AEs listed in the drug insert were validated through this analysis. In addition to the improvement of the drug process, the focus should still be on the adverse reactions such as Dysgeusia, Nasal discomfort, and Somnolence. CONCLUSION: This study systematically depicts the safety profile of azelastine by analysing large-scale adverse reaction data and provides empirical evidence for the improvement of clinical dosing guidelines and risk communication strategies. Pharmacovigilance departments should maintain vigilance for rare but serious adverse reactions to azelastine to optimize its risk-benefit profile.
Assessing the Risk of Drug-Induced Influenza-Like Illness: A Disproportionality Analysis of Two Decades of FAERS Data (2004-2025).
Gao X, Chen X, Zu J … +1 more , Liu T
Curr Drug Saf · 2026 May · PMID 42227479 · Publisher ↗
INTRODUCTION: With the rising incidence of Influenza-like Illness (ILI), comprehensive studies on causative drugs remain lacking. This study aimed to detect drugs associated with ILI through disproportionality analysis o...
INTRODUCTION: With the rising incidence of Influenza-like Illness (ILI), comprehensive studies on causative drugs remain lacking. This study aimed to detect drugs associated with ILI through disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) database. METHODS: Adverse Event (AE) reports were extracted from the FAERS database for the period spanning 2004 Q1 through 2025 Q1. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify ILI cases. Four statistical methods were employed to identify drugs with positive signals: the Reporting Odds Ratio (ROR), the Proportional Reporting Ratio (PRR), the Bayesian Confidence Propagation Neural Network (BCPNN), and the Empirical Bayes Geometric Mean (EBGM). RESULTS: Our analysis identified 77,060 ILI-associated reports. A total of 60 drugs exhibited positive signals. The 5 most frequently reported drugs were interferon β-1a, evolocumab, ofatumumab, interferon β-1b, and zoledronic acid. Under the ATC1 classification, antineoplastic and immunomodulating agents accounted for the majority of reported cases (n=43,436), followed by nervous system agents (n=8,941), cardiovascular system agents (n=6,871), and musculoskeletal system agents (n=5,577). Weibull shape parameter analyses revealed β<1 for most drugs, indicating that drug-induced ILI predominantly manifested early failure types. DISCUSSION: This study confirms known ILI risks (e.g., interferons) and reveals new signals for immunotherapies and lipid-lowering agents, providing evidence for prescribing updates. Timeto- onset analysis shows declining risk over time, highlighting the need for early symptom monitoring. CONCLUSION: This first comprehensive FAERS study identifies key drugs associated with ILI, including interferon β-1a, evolocumab, ofatumumab, interferon β-1b, and zoledronic acid. Clinical monitoring for drug-induced ILI is essential to enhance medication safety.
Pharmacovigilance Assessment of Thrombotic Adverse Events Linked to GLP-1 Receptor Agonists: Analysis of FAERS Reports from 2020-2025.
Mansory EM, Radhwi OO
Curr Drug Saf · 2026 May · PMID 42227478 · Publisher ↗
INTRODUCTION: Glucagon-like peptide-1 receptor agonists are widely prescribed for diabetes and obesity. The association between GLP-1 RAs and thrombotic events remains unclear, with conflicting evidence from clinical and...
INTRODUCTION: Glucagon-like peptide-1 receptor agonists are widely prescribed for diabetes and obesity. The association between GLP-1 RAs and thrombotic events remains unclear, with conflicting evidence from clinical and experimental studies. This study aims to assess the reporting of thrombotic adverse events with GLP-1 RAs in the FDA Adverse Event Reporting System (FAERS). METHODS: A retrospective pharmacovigilance analysis of FAERS reports was performed. Thrombotic adverse events were identified using Standardized MedDRA Queries. Disproportionality was assessed via Reporting Odds Ratios. Time-to-onset was analyzed, and comparative analyses were conducted with Orlistat and SGLT2i. RESULTS: 1,618 unique thrombotic AE reports involving GLP-1 RAs were identified. Arterial events predominated (55.3%), followed by venous (23.2%) and mixed events (21.5%). Compared with all other drugs, GLP-1 RAs were not disproportionately associated with thrombotic AEs (overall ROR = 0.67, 95% CI: 0.64-0.71). Venous events showed the lowest disproportionality (ROR = 0.53, 95% CI: 0.48-0.59). Liraglutide displayed higher RORs than other GLP-1 RAs, while tirzepatide showed the lowest. Compared with Orlistat, GLP-1 RAs had markedly lower odds of venous events (OR 0.27), and, versus SGLT2i, lower odds across all event types. DISCUSSION: In this large FAERS analysis, GLP-1 RAs did not show a disproportionate reporting signal for thrombotic events and, in several comparisons, appeared to have lower thrombotic reporting than alternative agents. While limitations of spontaneous reporting preclude causal inference, these findings provide reassuring real-world safety data. CONCLUSION: GLP-1 RAs were not associated with thrombotic AEs in FAERS and may confer a protective profile. Continued post-marketing surveillance is warranted.
The Possible Protective Effect of Cerium Oxide Nanoparticles on Colistin-Induced Injury in Renal Cortex of Adult Male Albino Rats: Light and Electron Microscopic Study.
Helal AI, Marei AY, Abo Gazia MM … +2 more , Abdelbaky S, Abd-Elsalam MM
Curr Drug Saf · 2026 May · PMID 42227477 · Publisher ↗
INTRODUCTION: Acute Kidney Injury (AKI) is a rapid decline in renal function. Colistin, a last resort antibiotic for multidrug-resistant infections, is associated with significant nephrotoxicity. Cerium oxide nanoparticl...
INTRODUCTION: Acute Kidney Injury (AKI) is a rapid decline in renal function. Colistin, a last resort antibiotic for multidrug-resistant infections, is associated with significant nephrotoxicity. Cerium oxide nanoparticles (CeONPs) are potent scavengers of reactive oxygen species (ROS), exhibiting antioxidant and anti-inflammatory properties. This study aimed to investigate the protective effects of CeONPs against colistin-induced renal damage in adult male albino rats. METHODS: Forty-eight adult male albino rats were equally divided into four groups: Group I (Control), Group II (CeONPs), Group III (Colistin), and Group IV (CeONPs + Colistin). At the end of the experiment, blood samples were collected to assess renal function by measuring serum urea and creatinine. Kidney tissue was processed for histological examination and immunohistochemical staining to evaluate the expression of the inflammatory marker for nuclear factor Kappa B (NF-κB). RESULTS: Colistin administration in Group III resulted in significant renal impairment, characterized by elevated serum urea and creatinine, severe histopathological damage (including tubular necrosis), and a marked increase in NF-κB expression. In contrast, rats pre-treated with CeONPs (Group IV) demonstrated significantly improved kidney function tests, a substantial reduction in histopathological lesions, and a notable decrease in NF-κB expression compared to the colistin group. DISCUSSION: Colistin induces AKI through increased membrane permeability, oxidative damage, and acute tubular necrosis. This oxidative stress upregulates inflammatory mediators like NF- κB, exacerbating tissue injury. The renoprotective effect of CeONPs is attributed to their unique ability to switch between Ce³⁷ and Ce³⁷ oxidation states, allowing continuous ROS scavenging. By reducing oxidative stress, CeONPs also suppress the NF-κB-mediated inflammatory pathway. CONCLUSION: CeONPs exhibit notable nephroprotective effects against colistin-induced AKI through their antioxidant and anti-inflammatory characteristics. These findings propose CeONPs as a potential therapeutic adjunct to reduce nephrotoxicity in patients requiring colistin treatment.
Tenecteplase for Acute Ischemic Stroke: Improved Handling in Emergency Conditions.
Siniscalchi A, Gallelli L, Anticoli S … +1 more , Amantea D
Curr Drug Saf · 2026 May · PMID 42152263 · Publisher ↗
Tenecteplase, a genetically modified recombinant tissue plasminogen activator with a long half-life, has recently been proposed as a valid alternative to alteplase for thrombolysis in patients with acute ischemic stroke....
Tenecteplase, a genetically modified recombinant tissue plasminogen activator with a long half-life, has recently been proposed as a valid alternative to alteplase for thrombolysis in patients with acute ischemic stroke. According to clinical studies and trials, tenecteplase has several practical advantages over alteplase, including administration by single bolus rather than continuous infusion, shorter treatment duration, and possibly associated with fewer complications. Not only do these features increase the efficiency of emergency department workflow, but they also enable faster reperfusion and more rapid transfer to thrombectomy-capable centers. Although clinical evidence strongly suggests that tenecteplase has greater efficacy and safety, its use may lead to implemented "bridging therapy" in terms of rapid administration of a full dose of intravenous fibrinolytics before endovascular thrombectomy, enhanced recanalization rates, and improved efficacy of thrombolytic treatment in ischemic stroke patients.
Descriptive Analysis of Adverse Drug Events of Three mTOR Inhibitors Using WHO-VigiAccess.
Bhati P, Haloi P, Chitme HR
Curr Drug Saf · 2026 May · PMID 42152262 · Publisher ↗
INTRODUCTION: The mechanistic target of rapamycin (mTOR) pathway regulates cell growth, metabolism, and survival. Its dysregulation contributes to cancer, autoimmune disorders, neurodegeneration, and aging. While mTOR in...
INTRODUCTION: The mechanistic target of rapamycin (mTOR) pathway regulates cell growth, metabolism, and survival. Its dysregulation contributes to cancer, autoimmune disorders, neurodegeneration, and aging. While mTOR inhibitors such as Sirolimus, Everolimus, and Temsirolimus are therapeutically valuable, they are linked to significant adverse drug reactions (ADRs). OBJECTIVE: To investigate adverse events (AEs) and ADRs associated with mTOR inhibitors using the World Health Organization's VigiAccess database. METHODS: A retrospective descriptive analysis was conducted using ADRs reports from WHOVigiAccess (2000 onward). Data included patient demographics and geographic distribution. Statistical measures such as odds ratios and relative risks were applied to assess risks. RESULTS: Sirolimus showed a 132% increased risk of gastrointestinal (GI) hemorrhage, alongside oral ulceration, highlighting mucosal toxicity. It was also linked to a 67% higher risk of interstitial lung disease and a 63% increased likelihood of ascites. Temsirolimus was associated with a 40% higher risk of pneumonia and a 36% higher risk of sepsis, reflecting immunosuppressive effects. DISCUSSION: The findings underscore the diverse and serious ADRs of mTOR inhibitors, ranging from gastrointestinal and pulmonary complications to heightened infection risk. These outcomes emphasize the need for careful monitoring and risk-benefit evaluation in clinical use. CONCLUSION: mTOR inhibitors, while effective, pose substantial risks of ADRs including hemorrhage, lung disease, ascites, and infections. Clinicians should weigh therapeutic benefits against potential harms and adopt vigilant monitoring strategies to optimize patient safety.
Liraglutide Causing Pancreatitis in an Indian Obese Female: A Case Report and Review of the Literature.
Singh J, Dinkar A, Verma R … +3 more , Patel ML, Patwa AK, Bharti N
Curr Drug Saf · 2026 May · PMID 42136236 · Publisher ↗
INTRODUCTION: Liraglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), is commonly prescribed for obesity and type 2 diabetes mellitus (T2DM). While its metabolic benefits are well-established, rare cases of a...
INTRODUCTION: Liraglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), is commonly prescribed for obesity and type 2 diabetes mellitus (T2DM). While its metabolic benefits are well-established, rare cases of acute pancreatitis (AP) have raised concerns about drug safety. Despite regulatory warnings from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), causality remains debated due to confounding factors and limited human data. CASE PRESENTATION: We, herein, report the case of a 42-year-old Indian female with obesity (BMI 32.5 kg/m²) who developed acute-onset severe epigastric pain and vomiting three days prior to presentation. She had been using liraglutide 0.6 mg/day for one month for weight management. Laboratory investigations revealed significantly elevated serum amylase and lipase, while abdominal ultrasonography and contrast-enhanced CT scan confirmed acute interstitial edematous pancreatitis. No other common etiologies were identified. Prompt discontinuation of liraglutide and supportive care resulted in full clinical recovery within five days. CONCLUSION: A systematic literature search yielded 10 relevant case reports encompassing 11 cases of liraglutide-induced acute pancreatitis, with our case bringing the total to 12. These cases showed a slight male predominance and favorable outcomes with conservative treatment. Our report thus highlights the need for clinician vigilance and risk-benefit assessment when prescribing liraglutide, emphasizing early drug cessation upon suspicion of pancreatitis.
Comparison of the Effects of Low-Dose Versus Standard-Dose Cyproheptadine on BMI Increase in Children and Assessment of its Adverse Drug Reactions: A Randomized Clinical Trial.
Javidmehr N, Talakesh T, Raeisi H … +2 more , Talakesh H, Heidari-Soureshjani S
Curr Drug Saf · 2026 Apr · PMID 42083352 · Publisher ↗
INTRODUCTION/OBJECTIVE: Childhood underweight and low body mass index are major public health concerns. There is no definitive evidence on the dosage adjustment of Cyproheptadine as an appetite stimulant. This study aime...
INTRODUCTION/OBJECTIVE: Childhood underweight and low body mass index are major public health concerns. There is no definitive evidence on the dosage adjustment of Cyproheptadine as an appetite stimulant. This study aimed to evaluate the effect of Cyproheptadine on Body Mass Index (BMI) in underweight children and assess its associated adverse effects. METHODS: This randomized double-blinded clinical trial study was conducted on thin children aged 2 to 10 years. The study was conducted on three groups of 92 children receiving low-dose Cyproheptadine, standard-dose Cyproheptadine, or placebo. Children were assessed monthly for 4 months for changes in anthropometric indices and treatment-related side effects. Data were analyzed using SPSS version 23 Results: Mean BMI showed significant between-group differences at three and four months (p = 0.001 and p < 0.001, respectively). Drowsiness occurred significantly more often in the standard- dose group than in the low-dose group at all visits (p < 0.001). No significant differences between groups in terms of irritability (p > 0.05). Mood swings were consistently more frequent in both Cyproheptadine groups than in the placebo group (p = 0.03). DISCUSSION: These results are consistent with prior evidence supporting Cyproheptadine's role in promoting weight gain and add important insight into dose-related safety. However, the short follow-up period limits conclusions about long-term outcomes. CONCLUSIONS: Low-dose cyproheptadine is an effective and safer therapeutic option for increasing BMI in children, offering efficacy comparable to the standard dose with fewer adverse effects. These results also highlight the necessity of long-term monitoring to ensure sustained efficacy and safety.
The Treatment of Nociceptive Pain in DOAC-treated Patients: Could it be Safe?
Marcianò G, Rania V, Vocca C … +2 more , Palleria C, Gallelli L
Curr Drug Saf · 2026 Apr · PMID 42003074 · Publisher ↗
Direct oral anticoagulants (DOACs) are widely prescribed in patients at risk of thromboembolism. Although they are generally safer than warfarin, DOACs still carry a risk of bleeding and drug-drug interactions (DDIs). No...
Direct oral anticoagulants (DOACs) are widely prescribed in patients at risk of thromboembolism. Although they are generally safer than warfarin, DOACs still carry a risk of bleeding and drug-drug interactions (DDIs). Nociceptive pain is common and may frequently occur in patients receiving DOAC therapy. In these cases, the European Society of Cardiology recommends avoiding non-steroidal anti-inflammatory drugs (NSAIDs) and preferring acetaminophen. However, acetaminophen is not effective when an inflammatory component is present. Consequently, non-pharmacological approaches or topical NSAIDs are suggested, while, in selected cases, lower-risk NSAIDs such as ibuprofen may be considered. Available evidence clearly indicates that concomitant treatment with NSAIDs and DOACs is associated with an increased risk of bleeding, although the magnitude of risk appears to differ across compounds. In this narrative review, we summarize the current evidence on bleeding risk associated with NSAID-DOAC coadministration, discuss potential DDIs from a pharmacokinetic perspective, and outline directions for future research.
Suspected Cutaneous Adverse Reaction Due to Oral Consumption of Siddha Polyherbo-Mineral Formulation, Gandhaga Rasayanam: A Case Report.
Subathra T, Chandan N, Barvaliya M … +2 more , Shanmugapriya P, Senthilvel G
Curr Drug Saf · 2026 Apr · PMID 41969163 · Publisher ↗
INTRODUCTION: The Siddha formulation Gandhaga Rasayanam (GRM) is a classical polyherbo-mineral medicine containing purified sulphur and other herbal ingredients, including Schedule E(1) drugs. It is traditionally used to...
INTRODUCTION: The Siddha formulation Gandhaga Rasayanam (GRM) is a classical polyherbo-mineral medicine containing purified sulphur and other herbal ingredients, including Schedule E(1) drugs. It is traditionally used to manage chronic ailments and dermatological conditions. Limited safety data have been documented for Siddha medicines; this report highlights a suspected adverse cutaneous reaction probably associated with GRM. CASE SUMMARY: A 36-year-old female treated for residual Padarthamarai (Tinea cruris) developed elevated plaque with ill-defined, diffuse borders over the neck and upper back on Day 3 of therapy with GRM in combination with other Siddha medicines. This lesion was inflamed, warm to the touch, and associated with pruritus, itching, and burning. The lesions subsided markedly upon GRM withdrawal and resolved completely after a short course of levocetirizine. The patient was advised to resume other internal medicines, excluding GRM, the most suspected drug, and no recurrence was observed. This implicates GRM as the probable cause of the adverse reaction. CONCLUSION: This case highlights the potential for adverse reactions even with traditionally regarded safe Ayush formulations and emphasizes the need for vigilant pharmacovigilance and systematic documentation of adverse events to ensure patient safety.
Assessment of Iguratimod's Efficacy and Safety in Rheumatoid Arthritis: A Prospective, Open-Label Study.
Banupriya B, Al Rashid S, Selva P
Curr Drug Saf · 2026 Mar · PMID 41941329 · Publisher ↗
OBJECTIVE: This study investigates the therapeutic effectiveness and safety profile of iguratimod (IGU) in patients with moderate to severe pain due to active rheumatoid arthritis (RA), utilizing the Disease Activity Sco...
OBJECTIVE: This study investigates the therapeutic effectiveness and safety profile of iguratimod (IGU) in patients with moderate to severe pain due to active rheumatoid arthritis (RA), utilizing the Disease Activity Score-28 Erythrocyte Sedimentation Rate (DAS28-ESR) as the primary assessment criterion. METHODS: A prospective, open-label study was carried out at the Department of Rheumatology, Saveetha Medical College and Hospital, to evaluate IGU over a period of 16 weeks. Patients diagnosed with moderate to severe pain due to active RA were recruited, with clinical parameters including swollen joint count (SJC), tender joint count (TJC), physician's global assessment (PHYSGA), and ESR recorded at baseline, 8 weeks, and 16 weeks. The study was conducted over a span of four months, from February to May 2020. Statistical analysis was performed using the Friedman test. RESULTS: A total of 40 patients received iguratimod therapy. Significant reductions were noted across all DAS28-ESR parameters. The mean baseline DAS score was 4.74 ± 0.47, which declined to 3.36 ± 0.48 at 8 weeks and further to 2.59 ± 0.62 at 16 weeks (p=0.0001). Individual improvements included reductions in SJC (3.49 ± 1.79 to 0.38 ± 0.49), TJC (5.73 ± 2.18 to 0.49 ± 0.51), PHYSGA (5.89 ± 1.68 to 1.81 ± 1.18), and ESR (62.49 ± 21.57 to 27.16 ± 14.62) over 16 weeks (p=0.0001 for all comparisons). CONCLUSION: Iguratimod significantly reduced disease activity in RA patients over 16 weeks, as evidenced by improvements in DAS28-ESR scores. These findings highlight IGU as an effective treatment option for RA. Further long-term research is required to determine its sustained efficacy and safety. CLINICAL TRIAL REGISTRATION: 004/01/2020/IEC/SMCH.
Nirmatrelvir-Ritonavir (Paxlovid) in Patients with Epilepsy: A Focus on Drug-Drug Interactions.
Marcianò G, Vocca C, Siniscalchi A … +4 more , Rania V, Caroleo MC, Palleria C, Gallelli L
Curr Drug Saf · 2026 Mar · PMID 41941328 · Publisher ↗
INTRODUCTION: There is growing interest in identifying drug interactions between Paxlovid (nirmatrelvir/ritonavir), an antiviral drug used for the management of outpatients with mild to moderate coronavirus disease, and...
INTRODUCTION: There is growing interest in identifying drug interactions between Paxlovid (nirmatrelvir/ritonavir), an antiviral drug used for the management of outpatients with mild to moderate coronavirus disease, and antiepileptic drugs. METHODS: We searched the databases PubMed, MEDLINE, Cochrane, and EMBASE from their inception until 30 May 2025, using the keywords "Paxlovid" or "nirmatrelvir/ritonavir" or "antivirals COVID-19" and then "anticonvulsants" and finally "IDDs" and "drug interaction" in combination with Boolean logic operators. RESULTS: Clinical studies have reported strong and important drug-drug interactions between nirmatrelvir/ritonavir and antiepileptic drugs. Interactions with antiepileptic drugs are bidirectional. Moderate or strong CYP3A4 inducers among antiepileptic drugs should be dose-adjusted in patients taking nirmatrelvir/ritonavir. CONCLUSION: In patients with epilepsy treated with antiepileptic drugs who also use Paxlovid (nirmatrelvir/ritonavir), therapeutic monitoring and intervention on the therapeutic concentration with dose adjustment of the antiepileptic drug is recommended.
Prospective Assessment of Body Composition Changes with Sodium Glucose Transporters 2 (SGLT2) Inhibitors in Type 2 Diabetes Mellitus Using Bioelectrical Impedance Analysis.
Bhandari B, Kaliramana P, Agarwal P … +2 more , Panwar A, Srivastava S
Curr Drug Saf · 2026 Apr · PMID 41935354 · Publisher ↗
INTRODUCTION: Type 2 Diabetes Mellitus (T2DM) very often leads to adverse changes in body composition, including increased fat mass and sarcopenic obesity. Sodium-Glucose Co- Transporter 2 inhibitors are effective hypogl...
INTRODUCTION: Type 2 Diabetes Mellitus (T2DM) very often leads to adverse changes in body composition, including increased fat mass and sarcopenic obesity. Sodium-Glucose Co- Transporter 2 inhibitors are effective hypoglycaemic medications that also promote weight loss, but their specific impact on body composition remains unclear, particularly in Indian populations. Hence, this study intended to determine the extent of alterations in body composition parameters in T2DM patients on SGLT 2 inhibitor therapy using Bioelectrical Impedance Analysis (BIA). METHODS: This prospective observational study enrolled 60 adults with T2DM initiated on SGLT2 inhibitors along with standard therapy. BIA measurements were taken at baseline, 30 days, and 90 days. Parameters included Body Weight (BW), Body Mass Index (BMI), Skeletal Muscle Mass (SMM), Body Fat Mass (BFM), visceral fat percent, and ECW/TBW. Data from 55 patients were analysed. Descriptive statistics were calculated at baseline, 30 days, and 90 days and expressed as mean ± SD. The data were compared by means of repeated measures ANOVA. RESULTS: No significant changes in body composition were observed at 30 days. After 90 days, a statistically significant (p < 0.05) decrease in BW (73.4 ± 10.1 vs 70.4 ± 7.5), BMI (28.5 ± 3.0 vs 27.4 ± 2.6), BFM (30.7 ± 7.3 vs 28.6 ± 5.7), and visceral fat% (13.8 ± 4.4 vs 12.4 ± 3.0) was observed. SMM and ECW/TBW ratio remained unchanged. DISCUSSION: The results demonstrated no significant change in body composition parameters within the first 30 days of SGLT2 inhibitor therapy. However, by 90 days, there was a significant fall in body composition in terms of body weight, BMI, body fat mass, and visceral fat. No changes were observed in skeletal muscle mass and fluid composition during follow-up. The discrepancy in body composition could be due to variation in the patients' baseline measures and lifestyle habits, including diet and physical activity. Our study was limited by its short duration and use of BIA, which is an easy, non-invasive, and more practical modality, but lacks the precision of imaging modalities like DXA or MRI. Furthermore, muscle function was not assessed, which would provide more clinical relevance in interpreting muscle mass changes. CONCLUSION: Short-term (90-day) SGLT2 inhibitor therapy, primarily Dapagliflozin in T2DM patients, resulted in statistically substantial reductions in BW, BMI, BFM, and visceral fat percentage, with preservation of SMM and fluid balance. Future studies should target a larger sample size, longer follow-up durations, and include assessment of muscle strength. Additionally, the effect of lifestyle modification along with drugs on body composition can also be investigated.
In Vitro Evaluation of Simvastatin Nanoparticle-Coated Implant Healing Abutments: Cytotoxicity and Antibacterial Properties.
Torab A, Asadi Z, Memar MY … +4 more , Yekani M, Rasouli A, Sharifi S, Maleki Dizaj S
Curr Drug Saf · 2026 Apr · PMID 41935353 · Publisher ↗
INTRODUCTION: Simvastatin is a lipid-lowering drug with pleiotropic effects. Several studies have shown that it may have a protective effect on reducing morbidity and mortality from infections. One of the most devastatin...
INTRODUCTION: Simvastatin is a lipid-lowering drug with pleiotropic effects. Several studies have shown that it may have a protective effect on reducing morbidity and mortality from infections. One of the most devastating complications of orthopedic surgery is ImplantAssociated Infections (IAIs). Recently, newer strategies have been tried to reduce implant-related infections. Nanoparticles with antibacterial properties and coating on the healing implant abutment can improve implant performance. This study aimed to investigate the biocompatibility and antimicrobial effects of healing abutments coated with simvastatin nanoparticles (SIM-NPs). METHODS: The MTT assay was used to investigate the biocompatibility, and the time-kill assay was used to assess the antibacterial effect of abutments coated with SIM-NPs. RESULTS: The results showed that SIM-NPs coated on implant healing abutments had no cytotoxic effect. The time-kill assay showed that SIM-NP coating conferred antibacterial activity on implant healing abutments (p<0.05). DISCUSSION: The results emphasize the dual advantage of SIM-NP coatings that combine biocompatibility with antibacterial function. Their non-toxic profile protects surrounding tissues, while their antimicrobial function helps prevent initial bacterial attachment and peri-implant infections. CONCLUSION: The observaitons of this study suggest that SIM-NP coatings may be a valuable alternative to systemic antibiotic therapy, thereby reducing the possibility of antibiotic resistance and minimizing systemic side effects. However, additional studies in animal and clinical studies should be conducted before consideration for clinical application.
Itraconazole-Induced Motor Sensory Polyneuropathy in a Young Indian Male: An Unusual Case.
Singh J, Chaurasiya P, Dinkar A … +3 more , Patel ML, Patwa AK, Atam I
Curr Drug Saf · 2026 Apr · PMID 41935352 · Publisher ↗
INTRODUCTION: Itraconazole, a widely prescribed triazole antifungal agent, is generally well tolerated but can rarely cause neurotoxicity. Motor-sensory polyneuropathy secondary to itraconazole use is an exceptionally un...
INTRODUCTION: Itraconazole, a widely prescribed triazole antifungal agent, is generally well tolerated but can rarely cause neurotoxicity. Motor-sensory polyneuropathy secondary to itraconazole use is an exceptionally uncommon and underrecognized adverse effect. Although reversibility has been reported in several cases, delayed diagnosis or continued exposure may result in persistent neurological impairment. This case report aims to highlight a rare but clinically significant adverse effect-motor-sensory polyneuropathy-associated with prolonged itraconazole use in an otherwise healthy young adult. CASE PRESENTATION: We report the case of a 21-year-old previously healthy Indian male student who developed progressive weakness and sensory disturbances in both lower limbs, more pronounced on the left side, after two months of oral itraconazole therapy for onychomycosis. He presented with intermittent headaches for 20 days and worsening lower limb weakness over five days. Neurological examination revealed decreased power in the lower limbs (3/5 in the right lower limb and 2/5 in the left lower limb) and impaired sensation in all upper and lower limbs. Cerebrospinal fluid analysis and brain MRI were normal. Laboratory investigations excluded metabolic, infectious, and autoimmune causes. Nerve conduction studies confirmed motor-sensory polyneuropathy. Based on the clinical course, temporal association, and exclusion of other causes, itraconazole-induced neuropathy was diagnosed. The drug was discontinued, and supportive physiotherapy was initiated. The patient showed significant improvement during hospitalization and at one-month follow-up (5/5 in the right lower limb and 4+/5 in the left lower limb). CONCLUSION: This case emphasizes the importance of considering itraconazole-induced neuropathy in patients presenting with new-onset neurological symptoms, particularly when there is a clear history of recent itraconazole use. Early recognition and prompt withdrawal of the drug are crucial to prevent permanent neurological deficits and achieve functional recovery.
Different Therapeutic Doses of Sertraline Induce Liver Damage in Male Rats.
Beigmohamadi M, Asadollahi K, Adibi A … +2 more , Heidarizadi S, Azizi M
Curr Drug Saf · 2026 Mar · PMID 41930641 · Publisher ↗
INTRODUCTION: Sertraline is a first-line pharmacological treatment for Major Depressive Disorder (MDD) but can cause adverse effects, including acute hepatitis. This study aims to investigate, using an experimental male...
INTRODUCTION: Sertraline is a first-line pharmacological treatment for Major Depressive Disorder (MDD) but can cause adverse effects, including acute hepatitis. This study aims to investigate, using an experimental male rat model, the effects of different therapeutic doses of sertraline on liver damage. MATERIAL AND METHODS: Forty adult male Wistar rats were randomly divided into 5 groups (n=8): a control group and four groups receiving daily oral sertraline at doses of 20, 50, 100, and 200 mg/kg for two months. After the treatment period, serum levels of liver enzymes (AST, ALT, ALP), bilirubin, lipid profile (cholesterol, LDL, HDL), and inflammatory cytokines (TNF-α, IL- 6) were measured. Data were analyzed using SPSS 20 software with one-way ANOVA and ttest. RESULTS: The control group showed the lowest mean levels of all measured parameters. A clear dose-dependent increase was observed for cholesterol, LDL, bilirubin, AST, ALT, ALP, TNF-α, and IL-6, with the 200 mg/kg group consistently exhibiting the highest values. All variables in the 200 mg/kg group were significantly elevated compared to the control group (p<0.05). Among liver enzymes, ALP demonstrated the most pronounced dose-response, whereas bilirubin showed the weakest association with sertraline dosage. DISCUSSION: The findings demonstrate clear dose-dependent hepatotoxicity for sertraline, involving hepatic enzyme leakage, dyslipidemia, and pro-inflammatory cytokine activation. This provides experimental validation for clinical case reports of sertraline-induced liver injury. CONCLUSION: Sertraline causes dose-dependent liver damage in male rats, characterized by elevated liver enzymes, increased inflammatory markers, and adverse lipid changes. These results highlight the need for vigilant liver function monitoring in patients on higher therapeutic doses.
Neurological Complications of Prolonged Metronidazole Therapy: A Case of Reversible Encephalopathy.
Govani AA, Purohit BM, Patel JS … +1 more , Vadodariya BH
Curr Drug Saf · 2026 Mar · PMID 41926295 · Publisher ↗
INTRODUCTION: Metronidazole-induced encephalopathy (MIE) is a rare but potentially reversible adverse effect associated with prolonged metronidazole use. CASE PRESENTATION: We report a case of a 65-year-old male who deve...
INTRODUCTION: Metronidazole-induced encephalopathy (MIE) is a rare but potentially reversible adverse effect associated with prolonged metronidazole use. CASE PRESENTATION: We report a case of a 65-year-old male who developed progressive dizziness, ataxia, and confusion after 43 days of metronidazole therapy initiated for a ruptured liver abscess. MRI of the brain revealed bilateral symmetrical T2/FLAIR hyperintensities involving the dentate nuclei and dorsal brainstem, consistent with MIE. Cerebrospinal fluid analysis was inconclusive for infection. Prompt discontinuation of metronidazole led to rapid clinical improvement, with complete resolution of symptoms within 3 to 4 days. No corticosteroids were used. CONCLUSION: This case emphasizes the importance of considering MIE in patients on long-term metronidazole who present with neurological symptoms and highlights the role of MRI in diagnosis. Early recognition and withdrawal of the offending drug are critical to prevent permanent neurological damage.
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