Current Drug Safety[JOURNAL]
Sun
200 papers
Ethosomes- Novel Drug Delivery System in Herbal Formulations-A Review.
Kumar P, Singh Y, Singh SP … +2 more , Ojha M, Wal P
Curr Drug Saf · 2025 Aug · PMID 40776653 · Publisher ↗
A transdermal drug delivery system is a convenient drug delivery system where the drug enters the systemic circulation through the protective barrier, i.e., skin. Ethosomes are the ethanolic phospholipid vesicles, which...
A transdermal drug delivery system is a convenient drug delivery system where the drug enters the systemic circulation through the protective barrier, i.e., skin. Ethosomes are the ethanolic phospholipid vesicles, which are mainly used for transdermal delivery of medicines. They are nano-vesicular carriers for the topical application of the drugs. The major components of ethosomes are phospholipids, ethanol at relatively high concentrations (up to 50%), and water. The vesicles' composition and structure enhance their ability to entrap molecules with numerous physicochemical characteristics and bring them to the skin's deep layers. Because of their enhanced skin penetration, improved drug delivery, and higher drug entrapment efficiency, ethosomes have become more significant in the field of research. Skin acts as a major target and main barrier for topical or transdermal drug delivery and hence several approaches have been developed to weaken this skin barrier. Vesicular systems like ethosomes are the key approaches to increasing the skin penetration of medicines and various cosmetic components. Ethanol has been added to vesicular systems to create elastic nanovesicles because it is an effective penetration enhancer. For stability and simplicity of use, ethosomal dispersions are added to gels, patches, and creams. This review focuses on research using ethosomal formulations containing natural active compounds for the treatment of skin problems that has been done in vitro, in vivo in animal models, and on people in clinical investigations. Ethosomal systems have been shown to effectively control a variety of skin conditions, including bacterial and fungal infections, inflammation, acne vulgaris, arthritis, skin cancer, etc. Furthermore, ethosomes loaded with various naturally occurring components for cosmetic applications are also reported. The conception of new dermal therapies was made possible by the effective treatments, their good safety profile, and their lack of toxicity or irritation.
Drug-Induced Acute Kidney Injury: Mechanisms, Biomarkers, and Therapeutic Strategies.
Thawkar B, Rizwani F, Jain K
Curr Drug Saf · 2025 Jul · PMID 40662542 · Publisher ↗
Acute kidney injury (AKI) is a severe and life-threatening complication of drug therapy, a significant risk to patient well-being, with high morbidity and death rates. An increasing proportion of AKI cases are mainly cau...
Acute kidney injury (AKI) is a severe and life-threatening complication of drug therapy, a significant risk to patient well-being, with high morbidity and death rates. An increasing proportion of AKI cases are mainly caused due to drug-induced nephrotoxicity; despite its prevalence, the exact study of causative drugs is still unclear. AKI is often caused by kidney damage, reducing the kidneys' ability to detoxify, eventually leading to nephrotoxicity. Drug-induced nephrotoxicity often happens through various mechanisms such as crystal nephropathy, oxidative stress, reduced flow to the kidneys, damage to kidney cells, and thrombotic microangiopathy. Epidemiology of drug-induced nephrotoxicity focuses on how prevalent it is and the factors that increase the nephrotoxicity. Specific biomarkers have been found to assess nephrotoxicity for early and accurate diagnosis of kidney damage. This review focuses on explaining drug-induced nephrotoxicity mechanisms for commonly used agents such as non-steroidal anti-inflammatory drugs, immunosuppressants, antibiotics, anticancer agents, and antifungals. It also covers specific biomarkers and respective treatment approaches. Additionally, protective agents and their mechanisms in preventing nephrotoxicity are also analyzed, including their antioxidant and anti-inflammatory potential and other drug-based interventions. This review discusses various therapeutic studies using experimental models, offering invaluable insights into the cellular processes and pathways involved in developing prevention strategies. By advancing our understanding of the mechanisms behind drug-induced nephrotoxicity, it is aimed to improve patient care and reduce health-related complications.
Mitochondrial Dysfunction in Neurodegenerative Disorders: Role of Prototype Targeted Drug Delivery Solutions.
Singh D
Curr Drug Saf · 2025 Jul · PMID 40660446 · Publisher ↗
Mitochondrial dysfunction plays a central role in the pathogenesis of neurodegenerative disorders, including Alzheimer's disease (AD), Parkinson's disease (PD), Huntington's disease (HD), and Amyotrophic Lateral Sclerosi...
Mitochondrial dysfunction plays a central role in the pathogenesis of neurodegenerative disorders, including Alzheimer's disease (AD), Parkinson's disease (PD), Huntington's disease (HD), and Amyotrophic Lateral Sclerosis (ALS). Targeted drug delivery to mitochondria represents a promising therapeutic strategy to mitigate neuronal degeneration and preserve mitochondrial function in these devastating conditions. This review provides a comprehensive overview of recent advances in targeted drug delivery solutions for mitochondrial dysfunction in neurodegenerative disorders. The mechanisms underlying mitochondrial dysfunction in AD, PD, HD, and ALS are explored, highlighting the specific challenges and opportunities for therapeutic intervention. Emerging drug delivery technologies are discussed, including mitochondriaresponsive systems, nanoparticles, peptides, and viral vectors, designed to deliver therapeutic agents directly to mitochondria along with suitable case studies. Furthermore, preclinical and clinical studies evaluating the efficacy and safety of mitochondria-targeted therapeutics are reviewed, and future directions and challenges in the field are outlined. By elucidating the intersection of mitochondrial biology and drug delivery, this review aims to inspire further research and innovation toward effective treatments for neurodegenerative diseases.
An Unusual Adverse Drug Reaction to Thalidomide: A Case Report.
Peethambaran AS, Prabha N, Pujar P
Curr Drug Saf · 2025 Jul · PMID 40635225 · Publisher ↗
BACKGROUND: Thalidomide has emerged as a novel antitumor drug with antiangiogenic and immunomodulatory properties. It was taken off the market in the early 1960s due to its infamous connection with congenital defects. Re...
BACKGROUND: Thalidomide has emerged as a novel antitumor drug with antiangiogenic and immunomodulatory properties. It was taken off the market in the early 1960s due to its infamous connection with congenital defects. Recently, the FDA approved thalidomide for treating erythema nodosum leprosum, adhering to strict guidelines and safety measures. Sensory peripheral neuropathy and teratogenicity, fatigue, vertigo, headache, gastrointestinal issues, skin eruptions, dizziness, galactorrhoea, decreased libido, and constitutional symptoms like fever, weakness, headaches, and weight loss are the main adverse effects of thalidomide. CASE REPORT: We report a case of a 46-year-old female diagnosed with lepromatous leprosy on multibacillary multidrug therapy presenting with unusual adverse reactions, such as generalized burning sensation, breathlessness, and low backache after the intake of thalidomide. CONCLUSION: We describe an unusual adverse reaction to thalidomide that has not previously been reported in the literature and aim to alert clinicians about the unusual, adverse reaction as an uncommon side effect of thalidomide and to always keep in mind if the patient develops any of these symptoms.
Prevalence and Impact of Antibodies Against TNF Alpha Inhibitors in Rheumatoid Arthritis and Spondyloarthritis: Systematic Review and Meta- Analysis with Subgroup Analysis.
Mahmoud I, Bouden S, Charfi R … +8 more , Abid Y, Dziri C, Ben Sassi M, Rouached L, Tekaya AB, Tekaya R, Saidane O, Abdelmoula L
Curr Drug Saf · 2025 Jul · PMID 40611412 · Publisher ↗
OBJECTIVES: We aimed to estimate the global prevalence of anti-drug antibodies (ADAb), their impact on response, and associated factors in adults with rheumatoid arthritis (RA) and spondyloarthritis (SpA) treated by TNF...
OBJECTIVES: We aimed to estimate the global prevalence of anti-drug antibodies (ADAb), their impact on response, and associated factors in adults with rheumatoid arthritis (RA) and spondyloarthritis (SpA) treated by TNF alpha inhibitors (TNF-i). METHODS: We searched PubMed, MEDLINE, Cochrane, Web of Science, and Scopus for observational, population-based studies published between Jan 2010 and Sept 2021. We included studies that reported the prevalence of ADAb (our main outcome) and examined their impact on treatment efficacy in adults treated with TNF-i (secondary outcome). To investigate heterogeneity, we used a Q-test and predictive interval. RESULTS: The overall global prevalence of ADAb in RA was 20.8% (95%CI,6.8-25.5) (95%PI,6.12-51.42) and in SpA 24.8% (95%CI,19.1-31.5) (95%PI,7.31-57.98). There was no significant difference in the prevalence of ADAb between infliximab (IFX) and adalimumab (ADA) in RA (p=0.21) nor in SpA (p=0.46). There was a statistically significant difference between IFX and etanercept (ETN) in RA (p<0.0001) as well as in SpA (p=0.001) and, likewise, between ADA and ETN in RA (p<0.0001) and in SpA (p=0.002). Study by subgroups of the impact of immunogenicity on response, according to the type of TNF-i, showed that the mean OR for ADA was 0.152 (CI 95%, 0.054 to 0.427) and for IFX was 0.144 (CI 95%, 0.055 to 0.378). The pairwise comparison of ADA vs IFX was not statistically significant (p=0.94). In subgroup analysis, according to the disease, the mean OR for RA was 0.149 (IC 95% 0.064 to 0.347) and for SpA was 0.303 (IC95% 0.103 to 0.890). The pairwise comparison of RA vs SpA was not statistically significant. The use of methotrexate tends to reduce the development of ADAb in RA and SpA with an OR=0.472 (CI95%,0.324-0.689) (PI95%,0.16-1.39). CONCLUSION: ADAb were equally prevalent in RA and SpA treated with TNF-i. Immunogenicity was associated with response to treatment and influenced by concomitant use of methotrexate.
Exploring Vericiguat in Heart Failure: Mechanistic Insights, Therapeutic Advantages, and Clinical Validation.
Hao WR, Cheng CH, Chen HY … +3 more , Liu JC, Cheng TH, Chen JJ
Curr Drug Saf · 2025 Jun · PMID 40600528 · Publisher ↗
Vericiguat, a novel stimulator of soluble guanylate cyclase (sGC), marks a significant advancement in the management of heart failure with reduced ejection fraction (HFrEF). By enhancing the nitric oxide signaling pathwa...
Vericiguat, a novel stimulator of soluble guanylate cyclase (sGC), marks a significant advancement in the management of heart failure with reduced ejection fraction (HFrEF). By enhancing the nitric oxide signaling pathway, it facilitates vasodilation and improves myocardial function. Clinical trials, including the VICTORIA study, have demonstrated that vericiguat effectively reduces the risk of cardiovascular death and hospitalizations associated with chronic HFrEF. The favorable safety profile of this drug, with tolerability comparable to placebo, further supports its suitability for long-term use. Understanding the pharmacodynamics and pharmacokinetics of vericiguat is essential to appreciating its clinical efficacy and its role in current heart failure treatment strategies. This review explores existing research to explore the therapeutic potential of vericiguat, its practical implications for patient care, and the need for further investigation to expand its applications. By addressing unmet needs in heart failure management, vericiguat represents a promising addition to contemporary treatment paradigms.
Enhancing Pharmacovigilance in Pharmaceutical Companies: A Comparative Study of Electronic Reporting Before and After Implementation.
Meknassi Salime G, Bhirich N, Asraoui A … +3 more , El Karimi MEH, Rahali Y, Sefiani H
Curr Drug Saf · 2025 Jun · PMID 40598727 · Publisher ↗
BACKGROUND: Since 2016, Moroccan pharmaceutical companies have been required to report adverse effects linked to their medicines. Initially, reports were submitted using the CIOMS form, sent by normal mail to le Centre A...
BACKGROUND: Since 2016, Moroccan pharmaceutical companies have been required to report adverse effects linked to their medicines. Initially, reports were submitted using the CIOMS form, sent by normal mail to le Centre Antipoison et de Pharmacovigilance du Maroc, then using XML files in ICH E2B format, sent electronically. In 2021, a "vigiflow e-reporting for industry" standardized online reporting system was implemented. The primary objective of this study was to evaluate the pharmaceutical companies' use of electronic reporting. Secondarily, the study aimed to assess the quality of adverse drug reaction reports by comparing completeness scores across the three reporting means. METHODS: All individual case safety reports sent by pharmaceutical companies from January 1, 2019, to December 31, 2023, were extracted from Vigibase®. A quantitative and qualitative analysis was conducted, and a statistical comparison of data was performed using p-values. VigiGrade completeness score was calculated for a sample size selected. RESULTS: The highest number of reports were from E-reporting (50%), followed by CIOMS (29%) and E2B (21%). Between 2019 and 2021, CIOMS and E2B notifications decreased along with reporting laboratories. However, after 2021, electronic reporting increased steadily alongside reporting companies. Comparing vigiGrade completeness score across reporting means revealed no statistically significant differences (p = 0.094 > 0.05). CONCLUSION: Electronic reporting shows quantitative effectiveness and consistent quality. Its adoption remains limited and requires continuous strengthening, particularly through increased awareness among pharmaceutical companies.
Adverse Drug Reaction Profile of Capecitabine-based Chemotherapy Regimen and its Predisposing Factors in Patients Attending a Tertiary Care Hospital in South India.
Amar A, Mathaiyan J, Dubashi B
Curr Drug Saf · 2025 Jun · PMID 40511824 · Publisher ↗
BACKGROUND: Capecitabine, an important drug used for solid tumors involving the gastrointestinal tract, is known to be associated with many Adverse Drug Reactions (ADRs) leading to dose modification or discontinuation. O...
BACKGROUND: Capecitabine, an important drug used for solid tumors involving the gastrointestinal tract, is known to be associated with many Adverse Drug Reactions (ADRs) leading to dose modification or discontinuation. OBJECTIVE: The objective of this study was to determine the frequency and pattern of adverse drug reactions (ADRs) associated with capecitabine-based chemotherapy regimens (CBCR). METHODS: A prospective observational study was carried out at a regional cancer center in South India. A total of 120 cancer patients receiving CBCR were recruited and interviewed for the occurrence of any ADRs during the complete course of chemotherapy cycles. The adverse drug events were graded for severity as per the CTCAE criteria (v4.03), and causality assessment was done using the WHO and Naranjo scales. The preventability assessment of the ADRs was conducted using the modified Schumock and Thornton scale. The chi-squared test was used to analyze the difference in the frequency of ADRs among cancer types, genders, and chemotherapy regimens. RESULTS: The majority of ADRs (96.6%) reported throughout the treatment cycles were from the gastrointestinal system, followed by neurology-related events (93.3%). Among the various ADRs detected, skin/nail discoloration and fatigue/weakness were the most frequently reported. Causality analysis classified most ADRs under the "possible" category (50.5% by the WHO scale and 50.9% by the Naranjo scale). Most ADRs were of Grade I severity (54.5%) and were deemed "probably preventable." CONCLUSION: CBCR was associated with several ADRs, though most were of Grade I severity and primarily affected the gastrointestinal system. The majority of ADRs were classified as "possible" based on causality analysis, and most were deemed "probably preventable." Future research could focus on ameliorating these ADRs to avoid dose adjustments or discontinuation of chemotherapy.
The Impact of Non-Steroidal Anti-Inflammatory Drugs on Gastrointestinal Bleeding: Review on Risk Scoring for Better Prediction.
Nugrahaningsih DAA, Mustofa -, Pratiwi WR … +2 more , Mayasari DS, Chintyasari S
Curr Drug Saf · 2025 Jun · PMID 40511805 · Publisher ↗
Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed for pain relief and inflammation management; however, they can lead to serious upper gastrointestinal (GI) issues, including ulcers, bleeding, and pe...
Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed for pain relief and inflammation management; however, they can lead to serious upper gastrointestinal (GI) issues, including ulcers, bleeding, and perforations. This review explores various risk factors for NSAID-related GI complications, including medication dosage, duration of treatment, patient age, health history, and interactions with other drugs. It also evaluates existing measures to reduce these risks, such as using proton pump inhibitors (PPIs) and selective COX-2 inhibitors, while discussing their limitations. Emphasis is placed on the value of prediction tools that integrate multiple risk factors to enhance preventive care. The review provides an in-depth analysis of current scoring systems and examines future directions, including the integration of biomarkers, genetic data, and technologies like machine learning to improve prediction and clinical utility. By addressing gaps in existing models, it offers insights into advancing personalized approaches to minimize NSAID-induced GI complications.
DRESS Syndrome with Cold Agglutinins: An Unusual Immune Response to Anticonvulsants.
Jaiswal S, Pathania S, Sharma G … +4 more , Singh A, Kaur U, Singh A, Chakrabarti SS
Curr Drug Saf · 2025 Jun · PMID 40464181 · Publisher ↗
INTRODUCTION: DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) is a rare adverse drug reaction characterized by cutaneous and systemic manifestations, with a mortality rate of up to 10%. In this study, we de...
INTRODUCTION: DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) is a rare adverse drug reaction characterized by cutaneous and systemic manifestations, with a mortality rate of up to 10%. In this study, we describe the case of a 77-year-old man who developed DRESS syndrome with cold agglutination. CASE PRESENTATION: A 77-year-old man prescribed phenytoin and carbamazepine for suspected cranial neuralgia after a tooth extraction developed high-grade fever and hemorrhagic crusting on the upper and lower lips and oral mucosa, morbilliform rashes over the chest, abdomen, and back along with facial edema, all occurring over 2 weeks. Clinically significant right-sided submandibular, cervical, and axillary lymphadenopathy was observed. Additional findings, including peripheral blood eosinophilia, hepatitis, and coagulopathy, helped us make a provisional diagnosis of DRESS syndrome. The peripheral blood smear showed an incidental finding of cold agglutination phenomenon at room temperature (16 °C; winter months in North India), which disappeared under warmer conditions. However, gross hemolysis was not confirmed. The patient showed significant response in both clinical and hematological parameters within 24 hours of initiating intravenous dexamethasone, which was continued and gradually tapered over 14 days. Follow-up at one month showed the disappearance of the cold agglutination phenomenon. CONCLUSION: Cold agglutination in DRESS syndrome has not been documented in detail in the past. One hypothesis is the agglutination of red blood cells (RBCs) due to the effect of the pathogenetic antibodies in DRESS syndrome directed against RBC antigens. Further molecular research may elucidate the pathways of this rare clinical finding.
Evaluating the Impact of SGLT-2 Inhibitors on Frailty in Older Adults: A Clinical Review.
Al Rashid S, Gopalakrishnan AV, Maideen NMP … +1 more , Almalki RS
Curr Drug Saf · 2025 May · PMID 40454499 · Publisher ↗
BACKGROUND: Sodium-glucose cotransporter-2 (SGLT-2) inhibitors, including empagliflozin, canagliflozin, and dapagliflozin, have demonstrated significant cardiovascular and renal benefits in managing type 2 diabetes melli...
BACKGROUND: Sodium-glucose cotransporter-2 (SGLT-2) inhibitors, including empagliflozin, canagliflozin, and dapagliflozin, have demonstrated significant cardiovascular and renal benefits in managing type 2 diabetes mellitus (T2DM). However, their impact on frailty in older adults remains a subject of debate, given their associations with weight loss, fluid depletion, and potential reductions in muscle mass, which could contribute to sarcopenia and frailty-related complications. OBJECTIVES: This narrative review evaluates the effects of SGLT-2 inhibitors on frailty in older adults with T2DM by analyzing their influence on body composition, muscle mass, and overall functional status. It further examines the balance between their benefits and risks in frail populations, emphasizing the need for appropriate patient selection and monitoring strategies. METHODS: A comprehensive review of systematic reviews, meta-analyses, randomized controlled trials (RCTs), and real-world observational studies was conducted. Data were obtained from major medical databases, including PubMed, Embase, Cochrane Library, and Web of Science. Studies focusing on body composition changes, cardiovascular outcomes, frailty-related events, and mortality in older adults using SGLT-2 inhibitors were analyzed. RESULTS: Findings indicate that SGLT-2 inhibitors significantly reduce body weight, visceral fat, and cardiovascular events while preserving renal function. However, multiple studies report reductions in lean body mass and skeletal muscle index, raising concerns about sarcopenia, particularly in frail individuals. Meta-analyses of RCTs reveal that SGLT-2 inhibitors may decrease skeletal muscle mass while promoting lipolysis and gluconeogenesis, potentially exacerbating frailty in high-risk populations. Despite these concerns, retrospective cohort studies and real-world evidence suggest that SGLT-2 inhibitors are associated with lower mortality and reduced frailty-related events in individuals with T2DM and heart failure. Comparative studies highlight that SGLT-2 inhibitors provide superior cardiovascular protection over dipeptidyl peptidase-4 inhibitors (DPP- 4is) and comparable benefits to glucagon-like peptide-1 receptor agonists (GLP-1RAs), albeit with an increased risk of DKA and genital infections. CONCLUSION: While SGLT-2 inhibitors offer significant cardiometabolic and renal benefits, their effects on muscle mass and frailty warrant further investigation. Individualized treatment approaches- including nutritional support, exercise interventions, and close monitoring-are essential to mitigate potential risks in frail older adults. Updated clinical guidelines should address the appropriate use of SGLT-2 inhibitors in frail populations, considering both their benefits and risks. Future research should focus on elucidating the biological mechanisms underlying the relationship between SGLT-2 inhibitors and frailty, as well as developing strategies to prevent muscle loss in at-risk individuals.
Biosimilar Regulations: Current Framework and Future Prospects.
Kaur S, Yadav S, Sahu V … +2 more , Sharma N, Shukla VK
Curr Drug Saf · 2025 May · PMID 40417752 · Publisher ↗
INTRODUCTION/OBJECTIVE: Biosimilars, a class of biologic medications that are highly similar to reference biologics, have emerged as cost-effective alternatives to their expensive originator counterparts. Due to their co...
INTRODUCTION/OBJECTIVE: Biosimilars, a class of biologic medications that are highly similar to reference biologics, have emerged as cost-effective alternatives to their expensive originator counterparts. Due to their complex nature and manufacturing processes, biosimilars differ significantly from small molecule generics and must undergo a rigorous assessment to ensure safety, efficacy, and accessibility. This review explores the regulatory landscape surrounding biosimilars across key markets such as the United States, Europe, and India, with a focus on approval processes and post-marketing pharmacovigilance for patient safety. METHODS: The study conducted a detailed review of regulatory guidelines, approval frameworks, and post-marketing requirements for biosimilars across various countries. Data was collected from official sources such as the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA), and relevant Indian regulatory bodies. The research also analysed guidelines focusing on pharmacovigilance practices, particularly for vulnerable populations like paediatric and geriatric patients. RESULTS: The analysis found that while regulatory agencies such as the EMA and FDA have established stringent biosimilar approval pathways, India's regulatory framework, though promising, still lacks comprehensive pharmacovigilance guidelines. The harmonization of global biosimilar guidelines has contributed to their widespread adoption in new therapeutic areas and emerging markets, driving market expansion. The study highlights the importance of postmarketing monitoring to ensure continued safety, with particular emphasis on vulnerable populations. CONCLUSION: The regulatory landscape for biosimilars is evolving, with increasing global collaboration fostering the harmonization of guidelines. Regulatory agencies such as the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have established rigorous approval frameworks, ensuring biosimilars meet the necessary standards for safety and efficacy. In emerging markets like India, the biosimilar sector is poised for significant growth, though the regulatory framework is still maturing. Strengthening regulatory infrastructure, particularly in areas such as approval processes and quality control, will be crucial in supporting this expansion. The review emphasizes the importance of robust and clear regulations to facilitate the safe and effective integration of biosimilars into global healthcare systems, ensuring greater accessibility for patients without compromising on quality.
Dermocosmetic Bioactive: Safety Assessment and Regulatory Challenges.
Akram A, Gaur R, SIngh I … +1 more , Chauhan SB
Curr Drug Saf · 2025 May · PMID 40415297 · Publisher ↗
OBJECTIVE: This review investigates the regulatory framework for dermocosmetic bioactive in functional skincare, focusing on products with both cosmetic and pharmaceutical characteristics. The global regulatory environme...
OBJECTIVE: This review investigates the regulatory framework for dermocosmetic bioactive in functional skincare, focusing on products with both cosmetic and pharmaceutical characteristics. The global regulatory environment, with comparisons between the EU, the US, and India, will be analyzed, emphasizing the duality in regulation. Safety assessments, bioavailability, and toxicity concerns will be key focus areas, especially considering the impact of emerging technologies such as nanotechnology and AI-driven formulation development. METHOD: A comprehensive literature search was performed using PubMed and Google Scholar electronic databases. This involves a comparative analysis of regulatory frameworks governing dermocosmetic bioactives across the EU, US, and India, focusing on understanding differences and similarities in their approaches. Additionally, the review will cover safety assessment techniques, including in vitro methods, ex vivo skin permeation models, and bioavailability studies to evaluate product safety and efficacy. The exploration extends to emerging technologies such as nanotechnology and the use of machine learning for predictive toxicology. It also addresses virtual clinical trials and the integration of "-omics" data into safety evaluations, offering new insights into regulatory compliance and risk assessment. RESULT: The review highlights the need for adaptive regulations to balance innovation with consumer safety. Regulatory differences in the EU, US, and India reflect varying approaches to dual- function products. CONCLUSION: Advances in nanotechnology, AI, and machine learning offer new pathways for formulation development and safety assessments, suggesting a future where regulatory frameworks evolve to accommodate these innovations while ensuring product safety and efficacy.
A Review on Process Analytical Technology as a Driver of Pharmaceutical Manufacturing for the Improvement of Quality while Reducing Costs.
Adak R, Jana A, Debnath B … +2 more , Das A, Bandyopadhyay R
Curr Drug Saf · 2025 May · PMID 40390214 · Publisher ↗
Process analytical technology has emerged as a possible game-changing platform in the pharmaceutical business to improve process knowledge while also improving product quality and lowering production costs. This paper ou...
Process analytical technology has emerged as a possible game-changing platform in the pharmaceutical business to improve process knowledge while also improving product quality and lowering production costs. This paper outlines the underlying principles of PAT, its application in pharmaceutical manufacturing processes, and the impact on assurance of quality and reduction of cost. Real-time monitoring, multivariate data analysis, and process control strategies are three modules that are computed and integrated with PAT to develop robust and efficient manufacturing processes. A number of case studies and examples have been used to illustrate this relationship between the implementation of PAT and a reduction in variability with an improvement in process control and consistency of the product, which finally realizes million-dollar savings. It also debates the regulatory perspectives and challenges involved in PAT adoption, focusing on how stakeholders in the industry and agencies can integrate in developing and implementing innovations that will pass the test of compliance criteria. In general, what this paper presents is that PAT will drive pharmaceutical manufacturing into advancement for higher standards of quality with increased efficiency.
Identification and Detection of Pharmaceutical Impurities for Ensuring Safety Standard of Medicine: Hyphenated Analytical Techniques and Toxicity Measurements.
Azizuddin SK, Husain A, Rashid M … +2 more , Hashmi S, Kumar D
Curr Drug Saf · 2025 May · PMID 40375694 · Publisher ↗
Impurity separation and detection are essential processes in the pharmaceutical industry to preserve the quality of drugs as the impurities have the potential to significantly impair the therapeutic efficacy of an active...
Impurity separation and detection are essential processes in the pharmaceutical industry to preserve the quality of drugs as the impurities have the potential to significantly impair the therapeutic efficacy of an active ingredient and have negative effects on pharmaceutical formulations. The primary determinant of drug development is the creation of products that adhere to the highest standards of quality and safety, with a particular emphasis on effectively managing impurities in the therapeutic ingredients. To ensure that the resulting pharmaceutical possesses a high level of safety, meticulous identification, precise quantification, and stringent management of any extraneous components present in the drug ingredient need to be performed. The literature was compiled from different databases, such as DOAJ, PubMed, Research Gate, Google Scholar, Scopus, and Science Direct. Several organic and inorganic contaminants that are frequently present in final products and active pharmaceutical ingredients (APIs) were covered, along with the crucial section for quality control and fundamental details on their security, toxicity, detection limits, and quantification limitations. Pharmaceutical companies resolve the problem of the presence of impurities by adhering to strict regulatory requirements set by reputable agencies, like the ICH, USFDA, EMA, and PMDA. Also, impurity profiling is required for the regulatory submissions of new drug candidates. In some pharmacopoeias, impurity profiling and reporting are also included. To identify and measure contaminants, a variety of analytical techniques are employed, as discussed in this article. This paper covers the scientific features of contaminants present in pharmaceutical preparations, their prevention strategies, and the application of state-of-the-art analytical techniques for their detection.
Safety Profile of Amantadine: A Comprehensive Analysis of Real-World Adverse Events from the FDA Adverse Event Reporting System Database.
Chen W, Chen X
Curr Drug Saf · 2025 May · PMID 40370242 · Publisher ↗
BACKGROUND: Traumatic Brain Injury (TBI) is a significant public health issue, often leading to long-term cognitive, physical, and emotional impairments. Amantadine has emerged as a treatment option due to its potential...
BACKGROUND: Traumatic Brain Injury (TBI) is a significant public health issue, often leading to long-term cognitive, physical, and emotional impairments. Amantadine has emerged as a treatment option due to its potential neuroprotective properties, aiming to enhance recovery. However, its safety profile in TBI patients remains under scrutiny. OBJECTIVE: This study aimed to evaluate the safety of amantadine using the FDA Adverse Event Reporting System (FAERS) database, focusing on identifying novel adverse events to inform clinical decisions. METHODS: We analyzed adverse event reports of amantadine from FAERS (2004-2024), identifying 2766 reports where it was the primary suspect. Signal detection was conducted using ROR, PRR, BCPNN, and MGPS methods, ranked by ROR values. A gender subgroup analysis with Bonferroni correction ensured statistical significance. RESULTS: Among the 2766 reports, most events were related to nervous (n=2013, ROR=2.9) and psychiatric disorders (n=1631, ROR=3.46). Notable events included hallucinations (n=302, ROR=27.57), falls (n=286, ROR=5.7), and drug inefficacy (n=266, ROR=1.34). Adverse events were more common in patients aged 65+ years (48.5%) and slightly more frequent in females (49.3%). New adverse events identified included falls, drug inefficacy, tremors, and gait disturbances, mostly occurring within the first month of treatment (39.6%). CONCLUSION: The study revealed significant safety concerns with amantadine, especially regarding nervous and psychiatric reactions. It highlighted the need for careful monitoring in clinical use and further research to understand mechanisms, enhance therapeutic outcomes, and minimize adverse events.
Optimizing Antibiotic use and Awareness in Hospitals: Establishing Effective Antimicrobial Stewardship Pathways.
Donida BM, Mingolla G, Manfredi A
Curr Drug Saf · 2025 May · PMID 40353472 · Publisher ↗
BACKGROUND: Antibiotic resistance poses a significant challenge in healthcare, requiring effective management of antibiotic use. This study examines systemic antibiotic consumption at ASST Bergamo Ovest, a northern Itali...
BACKGROUND: Antibiotic resistance poses a significant challenge in healthcare, requiring effective management of antibiotic use. This study examines systemic antibiotic consumption at ASST Bergamo Ovest, a northern Italian hospital, from January 2022 to June 2023, with a focus on Healthcare-Associated Infections (HAIs) and prescription appropriateness. OBJECTIVE: This retrospective observational study aims to analyze antibiotic usage trends and to evaluate prescribing practices against national guidelines. METHODS: Data on systemic antibiotic consumption were reviewed, categorized by the AWaRe classification system (Access, Watch, Reserve), and analyzed using the Defined Daily Dose per 100 patient-days metric. RESULTS: The study observed a 7% overall reduction in antibiotic use, including a 5% decrease in the AWaRe Watch category. Despite this progress, the appropriateness of prescribing remained consistently low. These findings suggest partial alignment with the Italian Plan against Antibiotic Resistance but highlight the need for improvement in prescribing practices. CONCLUSION: While ASST Bergamo Ovest has reduced antibiotic consumption and the use of higher-risk antibiotics, low prescribing appropriateness underscores the need for enhanced real-time monitoring and more effective stewardship programs. Targeted interventions are essential to improve prescribing practices, combat multidrug-resistant infections, and meet European antibiotic stewardship standards.
Risk Assessment of Amiodarone Use in Patients with Cirrhosis and Heart Failure.
Kido K, Al-Mamun A
Curr Drug Saf · 2025 May · PMID 40353424 · Publisher ↗
BACKGROUND: Limited clinical evidence exists regarding the safety profile of amiodarone therapy in patients with heart failure (HF) who already have underlying cirrhosis. OBJECTIVE: The present study aimed to investigate...
BACKGROUND: Limited clinical evidence exists regarding the safety profile of amiodarone therapy in patients with heart failure (HF) who already have underlying cirrhosis. OBJECTIVE: The present study aimed to investigate the safety profile of amiodarone in patients with cirrhosis and HF concomitantly. METHODS: This was a retrospective cohort study with the TriNetX database using ICD-10 codes. Patients aged > 18 years with HF and cirrhosis receiving amiodarone for atrial fibrillation/flutter or ventricular tachycardia/fibrillation were compared with those not receiving amiodarone as a control group. Patients with end-stage renal disease were excluded. The primary outcome was a composite of all-cause mortality or all-cause hospitalization/emergency room visits. RESULTS: No significant differences in the primary outcome were found between the amiodarone and non-amiodarone groups (OR: 1.125 [95% CI: 0.956, 1.324]; P=0.158). The time-to-event analysis also revealed no significant differences in the primary outcome between the two groups (HR 0.949 [95% CI 0.816, 1.103], P=0.499). There were no significant differences in all-cause hospitalization/ emergency room visits (OR: 1.013 [95% CI: 0.880, 1.166]; P= 0.121), all-cause mortality (OR: 1.031 [95% CI: 0.901, 1.179]; P=0.656), and worsening hepatic function between two groups (OR: 0.943 [95% CI: 0.798, 1.115]; P=0.494). CONCLUSION: The amiodarone therapy in patients with underlying cirrhosis and heart failure may be reasonable with close liver function monitoring if the benefits outweigh the risks of amiodarone therapy.
A Descriptive Analysis from VigiAccess on Drug-related Problems Associated with the Glucagon-like Peptide-1 Receptor Agonists.
Amirthalingam P
Curr Drug Saf · 2025 May · PMID 40337971 · Publisher ↗
BACKGROUND: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are widely accepted for managing Type 2 diabetes mellitus. However, numerous drug-related problems (DRPs) have recently been reported about GLP-1 RAs. OBJ...
BACKGROUND: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are widely accepted for managing Type 2 diabetes mellitus. However, numerous drug-related problems (DRPs) have recently been reported about GLP-1 RAs. OBJECTIVES: The present descriptive study aimed to compile and report the DRPs of various GLP-1 RAs. METHODS: The DRPs reported for all the GLP-1 RAs, including exenatide, lixisenatide, liraglutide, dulaglutide, semaglutide, and tirzepatide, were extracted from the category of injury, poisoning, and procedural complications of VigiAccess. The Pharmaceutical Care Network Europe Association (PCNE) classification for drug-related problems (version 9.1) was used to categorize the DRPs into patient-related, healthcare practice-related, and patient- or healthcare practice- related. RESULTS: Overall, 315952 potential side effects (PSEs) were reported regarding GLP-1 RAs in VigiAccess under injury, poisoning, and procedural complications. Out of 315952 PSE reports, 83210 were DRPs of GLP-1 RAs. Most of them belong to Dulaglutide (23861; 28.68%), followed by tirzepatide (23274; 27.97%), exenatide (18449; 22.17%), semaglutide (11790; 14.97%), and liraglutide (5767; 6.93%). Among the patient-related DRPs, incorrect dose administered (17797; 42.42%), and most of the reports documented for tirzepatide (9993; 23.82%), dulaglutide (4581; 10.92%), and exenatide (2557; 6.10%); however, semaglutide (414; 0.99%), and liraglutide (249; 0.59%), have minor reports documented. Off-label use (13600), most of which were from tirzepatide (4945; 17.59%), followed by semaglutide (4176; 14.85%), liraglutide (1853; 6.59%), exenatide (1530; 5.44%), and dulaglutide (1087; 3.87%). CONCLUSION: Qualified healthcare practitioners must educate the patients administering the GLP- 1 RAs to minimize preventable DRPs. Also, careful and frequent monitoring of GLP-1 RAs improves therapeutic outcomes by ruling out DRPs. Healthcare practitioners should comply with approved therapeutic guidelines to enhance the quality of GLP-1 RAs treatment.
Understanding and Mitigating Cardiotoxicity in Anticancer Drug Therapy: A Comprehensive Review.
Devi S, Sharma S, Rani D … +3 more , Goel K, Singh S, Tripathi K
Curr Drug Saf · 2025 May · PMID 40329733 · Publisher ↗
Cancer and heart disease stand as the leading global causes of morbidity and mortality. Although advancements in cancer treatment have improved survival rates, the associated cardiovascular risks cannot be overlooked. Th...
Cancer and heart disease stand as the leading global causes of morbidity and mortality. Although advancements in cancer treatment have improved survival rates, the associated cardiovascular risks cannot be overlooked. This paper delves into the intricate relationship between cancer treatment and adverse cardiovascular events, emphasizing the critical role of factors such as drug type, dosage, administration mode, and treatment duration. Cardiotoxicity, which manifests as irreversible damage or reversible dysfunction, poses a significant challenge, with myocardial dysfunction potentially progressing to congestive heart failure. Various cardiac events, including hypertension, ischemia, and rhythm abnormalities, may be linked to cancer treatments, necessitating a nuanced understanding of their impact on the cardiovascular system. The review sheds light on the unexpected rates of cardiac dysfunction in cancer patients receiving both traditional chemotherapy drugs and novel chemotherapy drugs. Strategies for mitigating cardiovascular damage are explored, encompassing both synthetic medications and natural products as potential cardio protectants. The paper comprehensively explores the cellular and molecular pathways leading to cardiotoxicity induced by targeted therapy and chemotherapy. Additionally, it discusses cardioprotective tactics crucial for managing acute and chronic manifestations of cardiac damage, as well as diagnostic blood biomarkers for early detection. In light of the growing intersection between cancer and cardiovascular health, implementing effective strategies to safeguard the health of patients during cancer treatment becomes imperative for providing optimal patient care.
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