Current drug safety最新文献

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.