Current Drug Safety[JOURNAL]
Sun
200 papers
Trends in Complementary and Alternative Medicine Adoption by Cancer Patients.
Mahmoudi L, Mahi-Birjand M, Jamalzadeh N … +2 more , Niknam R, Karimzadeh I
Curr Drug Saf · 2025 May · PMID 40329732 · Publisher ↗
BACKGROUND: The use of Complementary and Alternative Medicine (CAM) in cancer patients is increasing. However, some patients are reluctant to disclose their use to their oncology treatment team. Often, the consumption of...
BACKGROUND: The use of Complementary and Alternative Medicine (CAM) in cancer patients is increasing. However, some patients are reluctant to disclose their use to their oncology treatment team. Often, the consumption of these products is not well studied, and little is known about their potential interactions with chemotherapy, radiation therapy, or biological methods, and their relationship to treatment outcomes. OBJECTIVE: In the present study, we examined the rate of supplement use in cancer patients treated with chemotherapy. METHOD: Patients who came to the University Cancer and Chemotherapy Center for treatment were asked to complete an anonymous questionnaire to assess their use of CAM. RESULTS: Among 395 patients, 62.5% reported using at least one type of CAM after their cancer diagnosis. The primary reasons for CAM use among participants were managing chemotherapy-related toxicities, reducing anxiety, and sedation. Vitamin and mineral use was reported by 72.4% of respondents, with vitamin D being the most popular (47.3% of respondents reporting use). CONCLUSION: The use of CAM is common among many cancer patients. CAM products may interact with chemotherapy drugs, potentially affecting treatment outcomes. Therefore, it is very important to take an accurate history of these products in every chemotherapy session in order to assess the safety of CAM consumption. Further research is required to evaluate the impact of CAM use on the efficacy and safety of cancer treatments.
A Rare Case of Peripheral Edema Induced by Topical Minoxidil: A Case Report.
Alkhwildi H, Alsaffar S, Bethlehem C
Curr Drug Saf · 2025 May · PMID 40329731 · Publisher ↗
INTRODUCTION: Minoxidil, initially developed as an oral antihypertensive, is widely used topically for hair regrowth. Off-label applications, such as beard enhancement, have gained popularity. While generally safe, syste...
INTRODUCTION: Minoxidil, initially developed as an oral antihypertensive, is widely used topically for hair regrowth. Off-label applications, such as beard enhancement, have gained popularity. While generally safe, systemic absorption of topical minoxidil can lead to rare side effects, like peripheral edema. CASE PRESENTATION: A 17-year-old male developed peripheral edema seven weeks after starting topical minoxidil 5% to promote beard growth. Initially, he experienced mild headaches in the fifth week, which resolved spontaneously. By the seventh week, he noticed swelling, which was exacerbated by prolonged immobility. Diagnostic evaluations, including Doppler ultrasound, echocardiography, ECG, and blood tests, were unremarkable. Edema resolved completely one to two weeks after discontinuation of minoxidil. CONCLUSION: Minoxidil's vasodilatory mechanism, which supports hair growth, can also lead to systemic effects, like peripheral edema due to fluid retention and increased capillary hydrostatic pressure. While rare with topical formulations, systemic absorption is influenced by factors, such as application area, concentration, and individual skin permeability. This case highlights a rare but clinically significant systemic side effect of topical minoxidil.
Knowledge and Perception of Vaccine Pharmacovigilance and Adverse Events Following Immunization Reporting Among Pharmacy Students in India: An Online-Based Cross-Sectional Study.
Byakod VR, Deva V, Pandare OS … +2 more , Bhandari R, Ganachari MS
Curr Drug Saf · 2025 Apr · PMID 40304337 · Publisher ↗
BACKGROUND: In India, the knowledge and perception of vaccine pharmacovigilance and adverse events following immunization (AEFI) reporting among pharmacy students are not clear. AIM: This study aimed to evaluate the curr...
BACKGROUND: In India, the knowledge and perception of vaccine pharmacovigilance and adverse events following immunization (AEFI) reporting among pharmacy students are not clear. AIM: This study aimed to evaluate the current knowledge and perceptions of vaccine pharmacovigilance and AEFI reporting among pharmacy students. METHOD: An online cross-sectional survey was conducted for three months. Validated structured questionnaires were circulated through emails and social media (Facebook and WhatsApp) to pharmacy students in India. RESULTS: A total of 205 responses (response rate = 53.5%) were received, out of which 196 consented to participate, and the remaining nine refused to participate in the study. The average knowledge score was found to be 7.54±1.78. In our survey, 82.7% of participants did not report AEFI. Moreover, 50% of participants reported that vaccine pharmacovigilance is not yet covered in the syllabus, and 66.3% said they were not trained during their studies for AEFI reporting. Timely reporting of AEFI can help to identify safety issues with vaccines, which can lead to improvements in vaccine safety. It was found that 96.9% of participants had a perception that pharmacists should be involved in reporting AEFI, and 95.4% of participants were willing to undergo training on vaccine pharmacovigilance. CONCLUSION: The AEFI reporting system, pri marily managed by pharmacists in India, highlights the need to include vaccine pharmacovigilance and AEFI reporting in the pharmacy curriculum. Continuous training programs are also essential to enhance knowledge and improve AEFI reporting practices.
Safety Reporting for Auxiliary Medicinal Products in the Sibeprenlimab Phase-III Study According to the New European Union (536/2014) CT Regulation.
Kumar R, Giri P, Huang M … +4 more , Parikh N, Khare V, Sheppard C, George V
Curr Drug Saf · 2025 Apr · PMID 40304336 · Publisher ↗
BACKGROUND: The new European Union clinical trials regulation (EU CTR 536/2014) became effective on 31 January 2022. It introduced the novel concept of Auxiliary Medicinal Products (AxMPs) to be implemented in clinical t...
BACKGROUND: The new European Union clinical trials regulation (EU CTR 536/2014) became effective on 31 January 2022. It introduced the novel concept of Auxiliary Medicinal Products (AxMPs) to be implemented in clinical trials in Europe. Otsuka submitted a Clinical Trial Application (CTA) under EU CTR for one of the ongoing clinical trials. The present manuscript discusses our approach to meeting the regulatory mandates for safety reporting requirements of AxMPs. OBJECTIVE: The aim of this study was to understand the changes introduced under the new EU CTR 536/2014 with respect to AxMP requirements, implement the new regulatory mandates for AxMPs, raise awareness among the sponsors on collection, analysis, and reporting obligation of adverse events (AEs) to AxMPs. METHODS: Using the cross-functional approach to incorporate new methods for collecting, reporting, and assessing adverse events with AxMPs, we identified the commonly prescribed Ax- MPs used to treat the target indication. We also updated our pharmacovigilance (PV) system [safety database] set up to ensure appropriate AxMP-related case processing and reporting. RESULTS: Based on impact assessment, PV processes related to safety data collection and submissions were updated to reflect EU CTR requirements for AxMPs. The study documents were updated to comply with AxMP-related regulatory obligations. World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) code level 4 was used to classify relevant AxMPs. Study drug configurations and user-defined field customizations were made to the safety database. CONCLUSION: From the gap analysis and impact assessment of EU CTR, appropriate changes were made to the existing PV processes, study-specific documents, and the safety database to ensure compliance with the EU CTR.
Adverse Drug Reactions of Low and Standard Doses of Risperidone in Schizophrenia Outpatients.
Boonlue T, Karnkla P, Jansela S … +1 more , Werawattanachai C
Curr Drug Saf · 2025 Apr · PMID 40257017 · Publisher ↗
BACKGROUND: Risperidone is an atypical antipsychotic commonly used in the treatment of schizophrenia. Despite its effectiveness, several adverse drug reactions can be bothersome to patients. OBJECTIVE: This study aimed t...
BACKGROUND: Risperidone is an atypical antipsychotic commonly used in the treatment of schizophrenia. Despite its effectiveness, several adverse drug reactions can be bothersome to patients. OBJECTIVE: This study aimed to examine the prevalence and characteristics of adverse effects in outpatients with schizophrenia treated with low (<4 mg/day) and standard (≥4 mg/day) doses of risperidone. METHOD: A cross-sectional study was conducted with 64 patients at a tertiary psychiatric hospital. Data on adverse effects were collected through a self-report questionnaire, and causality was assessed using Naranjo's Algorithm. Descriptive statistics and chi-square tests were employed for data analysis. RESULTS: The participants comprised 51.56% females, with a mean age of 45.16±14.32 years. Significant gender differences were observed between dose groups, with more females in the low-- dose group (63.16%) than in the standard-dose group (34.62%) (P = 0.02). A total of 221 adverse effects were confirmed after assessment. The most common effects were weight gain (57.81%), increased appetite (48.44%), and dystonia (32.81%). Weight gain was more prevalent in the low-- dose group (68.42%) than the standard-dose group (42.31%; Cohen's h = 0.53, 95% CI: 2.0%-50.2%), while insomnia was higher in the standard-dose group (23.08%) compared to the low-dose group (5.26%; Cohen's h = 0.54, 95% CI: 0.1%-35.5%). Other ADRs, such as dystonia and gastrointestinal symptoms, showed no significant differences between groups. CONCLUSION: Weight gain was the most prevalent adverse effect associated with risperidone use, particularly at lower doses, while insomnia was more frequent at standard doses, emphasizing the need for careful monitoring and personalized dose adjustments to optimize patient safety. Future studies with larger, longitudinal cohort designs are warranted to confirm these findings and evaluate long-term safety outcomes.
Insight Review on Data Quality Management in Pharmacovigilance.
Bassi P, Kaur N, Rana S … +2 more , Kaur A, Malik DS
Curr Drug Saf · 2025 Apr · PMID 40231501 · Publisher ↗
Pharmacovigilance is the scientific system developed to ensure the overall safety of a medicinal product by precise collection, compilation, and assessment of adverse drug-related events. The review focuses on the accura...
Pharmacovigilance is the scientific system developed to ensure the overall safety of a medicinal product by precise collection, compilation, and assessment of adverse drug-related events. The review focuses on the accurate evaluation of all the risk factors relevant to medicinal product use depending upon how precisely the adverse event data has been handled and processed to maintain by implementing quality standards at several stages, such as data entry, database selection, processing, and storage; this high-quality data can be obtained and maintained. In addition, the timeline in which data is received and reported to regulatory authorities is of vital importance. This review highlights key aspects of data quality management in pharmacovigilance focusing on data processing, management and its designing, regulatory guidelines, timelines for reporting of safety data, and the periodic safety update report (PSUR) process. Furthermore, the importance of reference safety information (RSI) and pharmacovigilance during healthcare emergencies is also highlighted. The evolution of pharmacovigilance systems, driven by automation and the WHO Drug Dictionary (WHO-DD) is examined, demonstrating how these developments enhance global safety monitoring, data accuracy, and reporting effectiveness. Therefore, for pharmacovigilance to ensure drug safety, high-quality data management is essential. Pharmacovigilance systems can be made more effective and efficient by utilizing digital tools and real-world data via automation and future technological improvements that can simplify data gathering and analysis.
Tubulointerstitial Nephritis in ANCA-Associated Vasculitis as a Rare Adverse Effect of Adalimumab: A Case Report.
Ayari M, Mtir M, Mami I … +4 more , Rais L, Ben Azouz S, Douggui H, Jomni T
Curr Drug Saf · 2025 Mar · PMID 40148300 · Publisher ↗
BACKGROUND: 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 tub...
BACKGROUND: 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. CASE REPORT: 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. CONCLUSION: 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.
Pharmacovigilance in Geriatrics: Exploration of Etio-Clinical Profile and Severity of Adverse Drug Reactions at a Tertiary Hospital in South India.
James J, B G, P K … +2 more , Rani J, V S
Curr Drug Saf · 2025 Mar · PMID 40143695 · Publisher ↗
BACKGROUND: 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 pr...
BACKGROUND: 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. METHODOLOGY: 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. RESULTS: 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. CONCLUSION: 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.
Linezolid Related Adverse Effects in Different Populations: A Practical Review.
Shahbazi F
Curr Drug Saf · 2025 Mar · PMID 40143694 · Publisher ↗
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, hyponat...
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 (>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.
Self-Micro-Emulsifying Drug Delivery Systems: In-Depth Review on Enhancing Solubility and Therapeutic Efficacy of BCS Class II Drugs.
Badhei L, Mishra D, Nandi P … +1 more , Samal HB
Curr Drug Saf · 2025 Mar · PMID 40143393 · Publisher ↗
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 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.
Certolizumab-Induced Urticarial Vasculitis: A Case Report.
Ouni B, Chahed F, Slim R … +6 more , Dridi B, Sassi M, Sriha B, Ghariani N, Bensayed N, Fathallah N
Curr Drug Saf · 2025 Mar · PMID 40143392 · Publisher ↗
INTRODUCTION: 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 desc...
INTRODUCTION: 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. CASE REPORT: 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. CONCLUSION: With the increasing use of CZ, physicians should be aware of the possibility of UV associated with CZ.
Clinical Manifestations of Neuropathic Pain and the Deleterious Effects of Chemotherapeutic Agents.
Ghosh M, Chakraborty M, Bhattacharjee A … +1 more , Bhuyan N
Curr Drug Saf · 2025 Mar · PMID 40129160 · Publisher ↗
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...
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.
Revealing the Future of Pharmacovigilance in Precision Pharmaceutical Monitoring.
Mittal V, Sharma A
Curr Drug Saf · 2025 Mar · PMID 40070333 · Publisher ↗
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 fo...
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.
Managing Opioid Tolerance: Balancing Pain Relief and Tackling Addiction.
Mehta A, Ashish A, Thakur S
Curr Drug Saf · 2025 Mar · PMID 40070059 · Publisher ↗
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...
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.
Efficacy and Safety Profile of Suvorexant for the Treatment of Insomnia.
Sabat A, Garg A, Khan MA
Curr Drug Saf · 2025 Mar · PMID 40033588 · Publisher ↗
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...
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.
A Biochemical Investigation of the Prevalence of Hypercalcemia and Thiazide-Related Hypercalcemia in Patients.
Masoodi SR, Bhat MH, Najar IA … +5 more , Khan MS, Bhat JR, Patyar S, Arora P, Kumar M
Curr Drug Saf · 2025 Feb · PMID 40012284 · Publisher ↗
OBJECTIVE: 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 t...
OBJECTIVE: 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). METHODS: 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). RESULTS: 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). CONCLUSION: 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.
Opioid Use Disorders: Prevention, Diagnosis, and Treatment Strategies to Mitigate Addiction Risks.
Agarwal U, Singhal K, Tonk RK
Curr Drug Saf · 2025 · PMID 39980292 · Publisher ↗
Opioid Use Disorder (OUD) is defined by the persistent use of opioids despite adverse consequences. It is associated with increased mortality and a variety of mental and general medical comorbidities. Risk factors includ...
Opioid Use Disorder (OUD) is defined by the persistent use of opioids despite adverse consequences. It is associated with increased mortality and a variety of mental and general medical comorbidities. Risk factors include younger age, male sex, lower educational attainment, lower income, and psychiatric disorders, such as other substance use disorders and mood disorders. Genetics also play a role in susceptibility to opioid use disorders. Long-term selfefficacy in opioid use for non-medical purposes suggests irreversible opioid use disorders. To evaluate the current understanding of opioid use disorders, the limitations in existing treatment approaches were examined, and strategies to improve outcomes through expanded treatment access and personalized care interventions were identified. An analysis was carried out regarding the role of existing pharmacological treatments, barriers within the care cascade, and potential advancements in healthcare delivery and innovation was carried out to address opioid use disorders. A comprehensive review of the literature was conducted by searching electronic databases (e.g., PubMed, Scopus) for articles published over the past 20-25 years. Relevant studies were selected based on predefined inclusion criteria, focusing on OUD risk factors, pharmacological treatments, barriers in the care cascade, and strategies for improving care. The selection process prioritized systematic reviews, clinical trials, and key guidelines. Although medications for opioid use disorders are effective, their impact is hindered by systemic issues at multiple levels of care. Addressing these challenges requires comprehensive efforts, including professional training, innovative treatments, and healthcare reforms to expand access and personalize care.
Advancements in Colon Cancer Therapy: A Review on Docetaxel and the Role of Nanotechnology in Enhancing Efficacy.
Komal, Kumar D, Khan SR … +4 more , Kaur P, Majumdar K, Chakraborty N, Singh A
Curr Drug Saf · 2025 Feb · PMID 39957692 · Publisher ↗
Docetaxel exhibits high protein binding and P450-mediated metabolism, which influences its pharmacokinetics. As a taxane-family chemotherapeutic agent, it stabilizes microtubules and disrupts cell division. Combining doc...
Docetaxel exhibits high protein binding and P450-mediated metabolism, which influences its pharmacokinetics. As a taxane-family chemotherapeutic agent, it stabilizes microtubules and disrupts cell division. Combining docetaxel with agents like 5-fluorouracil and oxaliplatin enhances treatment outcomes for colon cancer. Emerging drug delivery systems, including nanoparticles and micelles, aim to improve efficacy while reducing toxicity. However, its safety during pregnancy remains uncertain, and ongoing clinical trials continue to evaluate its therapeutic potential.
A Case Series of Anaesthesia Mumps - Could Drugs be the Cause?
Kapur A, Sharma M, Hazarika K
Curr Drug Saf · 2025 Feb · PMID 39957691 · Publisher ↗
INTRODUCTION: Acute parotid gland enlargement is an extremely rare post-surgical complication. Several etiological factors have been proposed, including preoperative dehydration, medications that cause an increase in vis...
INTRODUCTION: Acute parotid gland enlargement is an extremely rare post-surgical complication. Several etiological factors have been proposed, including preoperative dehydration, medications that cause an increase in viscosity of glandular secretions or loss of muscle tone and retrograde passage of air into the parotid glands, prolonged surgery, and operative position of the patient leading to pooling of secretions of the gland. CASE REPRESENTATION: We present a series of two cases that developed bilateral enlargement of parotid glands post-operatively. Case 1 was a 30-year-old male who underwent a Trendelenburg operation with flush ligation and ligation of perforators for varicose veins of the right leg under spinal anaesthesia with bupivacaine. Fentanyl, midazolam, bupivacaine, and ondansetron were administered to the patient perioperatively. Case 2 was a 51-year-old female who underwent laparoscopic cholecystectomy for cholelithiasis under general anaesthesia. Fentanyl, midazolam, sevoflurane, and vecuronium were administered to this patient during the surgery. Both of these cases were managed conservatively by adequate hydration, antibiotics, and analgesics, and they recovered completely three days following the surgery. CONCLUSION: The causative drug could not be well-established, but such cases stress that the surgeon, anesthetist, and patients should be aware of possibility of this adverse event. Postoperative anaesthesia mumps are usually of minimal clinical significance and resolve spontaneously with appropriate symptomatic care.
Pharmacovigilance - Technological Advancements, Recent Developments and Innovations.
Gomase VS
Curr Drug Saf · 2025 · PMID 39931995 · Publisher ↗
Pharmacovigilance is an important subject in medicine and healthcare, which aims to prevent side effects and other drug-related problems by identifying, evaluating, understanding, and avoiding them. Its main objectives a...
Pharmacovigilance is an important subject in medicine and healthcare, which aims to prevent side effects and other drug-related problems by identifying, evaluating, understanding, and avoiding them. Its main objectives are ensuring that a drug's benefits balance its hazards and improving patient safety. Within medicine and healthcare, pharmacovigilance is an essential subject that focuses on identifying, evaluating, comprehending, and preventing side effects or any other issues associated with drugs. Its main objective is to improve patient safety and ensure a drug's advantages exceed its drawbacks. Pharmacovigilance has evolved significantly as a result of technological advancements, enabling more efficient medication, safety monitoring, and management. The combination of machine learning (ML) with artificial intelligence (AI) for data analysis, adverse reaction prediction, and signal detection, electronic health records (EHRs), and mobile health (mHealth) applications have enhanced real-time data collecting and expedited the reporting of adverse drug reactions (ADRs). Pharmacovigilance plays an important role which focuses on detecting, assessing, comprehending, and averting adverse medication reactions. Making sure a drug's advantages outweigh its disadvantages is its main objective to improve patient safety. Pharmacovigilance, which balances patient safety, efficacy, and regulatory compliance in clinical trials, is necessary to promote the safe and effective use of drugs.
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