Myocarditis and pericarditis are managed with various treatments, yet prior studies and case reports indicate that certain drug classes may elevate the risk for these inflammatory cardiac conditions. This research aimed to systematically identify the leading drugs most frequently associated with myocarditis and pericarditis cases.
Analyses were carried out using VigiBase from 1968 to 2024, the World Health Organization's global database of individual case safety reports. We identified the drugs most frequently reported in association with myocarditis and pericarditis, selecting the top 10 drugs based on record count, excluding those used in the treatment of inflammatory cardiac conditions to avoid potential confounding. Two statistical indicators, the information component (IC) with IC₀₂₅ and reporting odds ratio (ROR) with 95% CI were used to conduct the disproportionality analysis in this study.
The following five drugs were consistently associated with both myocarditis and pericarditis: COVID-19 mRNA vaccine (reported in 76.2% of myocarditis cases and 88.2% of pericarditis cases), clozapine (15.3%; 2.9%), mesalazine (1.2%; 1.5%), smallpox vaccine (0.9%; 1.1%), and influenza vaccine (0.7%; 1.2%). The other leading drugs differed by condition, with nivolumab, pembrolizumab, ipilimumab, valproate, and metronidazole appearing more frequently for myocarditis, and ribavirin, sulfasalazine, methotrexate, omalizumab, and heparin for pericarditis. Each of these drugs showed a significant association with myocarditis (ROR, 83.22 [95% CI, 81.17–85.33]; IC, 3.96 [IC₀₂₅, 3.94]) and pericarditis (42.16 [41.19–43.16]; 3.66 [3.64]).
These findings highlight the importance of monitoring for possible adverse myocarditis and pericarditis reports when prescribing these drugs. Further studies are encouraged to investigate underlying mechanisms, assess individual patient risk factors, and explore the long-term impacts associated with drug-associated myocarditis and pericarditis.

Myocarditis and pericarditis; pharmacovigilance; Vigibase

Introduction The magnitude of short-term casual effect following recent increases in anticholinergic burden remains limited quantified in older populations.

Aims To quantify the short-term risk of urinary retention following recent elevations in anticholinergic burden and among Taiwanese adults aged ≥65 years.

Methods We performed a case–case–time–control analysis using the Taiwan National Health Insurance Research Database (NHIRD) from 2017–2021. Eligible future cases were with urinary retention 60–150 days after a matched reference event. For each individual, the hazard period was defined as the 60 days preceding the urinary retention; two referent periods consisted of randomly selected 60-day windows within days 121–300 before diagnosis. Anticholinergic burden was quantified using the Anticholinergic Cognitive Burden Scale and grouped as 0, 1–2, or ≥3 points. We used conditional logistic regression to estimate odds ratios (ORs) and 95% confidence intervals (CIs) comparing hazard versus referent periods, with and without adjustment for population and individual trends.

Results Among 135,116 matched individuals (mean age 78.3 ± 6.4 years; 73.3% male), short-term elevations in ACB score were significantly associated with urinary retention. In crude case-crossover analyses, ACB 1–2 yielded OR 1.80 (95% CI: 1.74–1.87) and ACB ≥3 yielded OR 2.31 (95% CI: 2.25–2.37). After controlling for population and individual trends in the case–case–time–control design, the ORs were 1.68 (95% CI: 1.57–1.80) for ACB 1–2 and 2.12 (95% CI: 2.03–2.22) for ACB ≥3.

Conclusions Older adults with recently elevated anticholinergic burden were associated with an increased risk of urinary retention. This demonstrates the importance of timely monitoring of anticholinergic burden and prompt deprescribing of anticholinergic medications to prevent unintended outcomes.

Keywords: anticholinergic burden, urinary retention, older adults

Introduction: Acne vulgaris is a common dermatological disorder that substantially impacts patient’s quality of life. Isotretinoin is an efficacious therapy for moderate to severe acne, although it is associated to several adverse drug reactions (ADRs). Although the safety and efficacy of isotretinoin have been extensively studied globally, data on patient satisfaction and ADRs in Nepal remain significantly limited.
Aims: To analyze patient satisfaction among acne patients and to characterize the adverse drug reaction profile associated with isotretinoin treatment.
Method: A prospective pre-post observational cohort study was performed with 267 acne patient. Patient demographics, acne severity assessed via the Investigator Global Assessment (IGA) scale, satisfaction ratings utilizing the Visual Analogue Scale (VAS), and biochemical data were documented at baseline and after six months of medication. ADRs reported at any point during the treatment period.
Results: The average age of participants was 22.94 ± 3.16 years, with 64.4% being female. The treatment led to an enhancement in patient satisfaction (6.82 ± 1.09 to 7.86 ± 0.51; p < 0.001). The incidence of at least one ADRs throughout the treatment duration was 86.5%, and they mostly appeared as mucocutaneous side effects, such as dry skin (31.5%) and dry lips (37.1%). Males had significantly lower odds of developing dry lips (OR = 0.545; 95% CI: 0.326-0.912; p = 0.02), nasal bleeding (OR = 0.105; 95% CI: 0.012-0.915; p = 0.013), and retinoid dermatitis (OR = 0.337; 95% CI: 0.133-0.857; p = 0.018). Males accounted for the majority of dermatosis papulosa nigra cases (7.4%; p < 0.001). Biochemical abnormalities included elevated triglycerides (4.5%) and LDL cholesterol (3.7%).
Conclusions: Isotretinoin treatment significantly improved patient satisfaction. Although ADRs were common, notable gender differences were identified, with males experiencing lower odds of mucocutaneous side effects.
Key words: Acne vulgaris; Isotretinoin; Adverse drug reaction; Patient satisfaction

Introduction: Facial erythema is a common dermatological condition, often associated with vascular dysregulation and skin hypersensitivity. Jet Peel PRO is a transdermal delivery system that enables the non-invasive infusion of active ingredients into the skin. Despite its growing popularity, there is still a lack of objective, quantitative methods to evaluate the effectiveness of such cosmetic treatments in reducing erythema.
Aim: To assess the clinical outcomes and skin effects of Jet Peel PRO treatment for facial erythema using multimodal imaging, including high-frequency ultrasound (HFUS), hyperspectral imaging, clinical photography, and GLCM texture analysis.
Methods: Thirty-six participants with persistent facial erythema underwent six weekly Jet Peel PRO treatments. Ultrasound imaging was used to confirm dermal penetration of the infused formulation. Clinical photographs were taken before, during, and after the treatment using the Fotomedicus system. Erythema severity was assessed using a Mexameter®. Hyperspectral imaging data were analyzed in the 400-1000 nm range. Texture features of the hyperspectral images were evaluated using the Gray Level Co-occurrence Matrix (GLCM), focusing on contrast and homogeneity.
Results: Post-treatment analysis revealed a significant decrease in GLCM contrast (p <0.01) and an increase in homogeneity (p <0.01), indicating improved structural uniformity of the skin. Hyperspectral reflectance analysis showed an increase in reflectance around 540 nm, suggesting a reduction in hemoglobin concentration, consistent with a decrease in erythema. Additionally, Mexameter® measurements demonstrated a noticeable decrease in erythema index values, confirming the clinical improvement observed through imaging.
Conclusion: Jet Peel PRO treatment reduces facial erythema. Objective imaging techniques, including hyperspectral analysis and GLCM-based texture evaluation, provide quantitative evidence of treatment efficacy. Limitations include short-term follow-up and restriction of the sample to Fitzpatrick phototypes I and II. Future research should explore long-term outcomes and efficacy across a wider range of Fitzpatrick phototypes.
Keywords: Transdermal delivery system, Facial erythema, GLCM texture analysis

Introduction: Medical devices improve healthcare but pose safety risks, especially in low-resource settings. Currently, the only standardized causality assessment scale for medical device-related adverse events is the European one. The absence of region specific, user-friendly scale hampers reporting, regulatory decisions, and Materovigilance efforts.
Aim: This study aimed to produce a clear, succinct, and adaptable causality assessment tool to detect medical device-associated adverse events (MDAEs).
Method: A causality assessment scale was developed using literature review and interviews, ensuring validity and real-world relevance. Validated for face, content, and construct validity, it was compared with the European standard using 50 cases. Reliability was confirmed via Cronbach’s alpha and Intraclass Correlation Coefficient (ICC) across two phases with expert raters.
Results: An improvised causality assessment scale comprising nine scored questions was developed to evaluate the relationship between medical device-associated adverse events (MDAEs) and medical devices. Each question allows responses of "Yes" (+1), "No" (-1), or "Do not know/Not applicable" (0), with total scores classifying causality as Certain (≥8), Probable (5–7), Possible (2–4), or Unlikely (<1). Validation against the European Union (EU) scale demonstrated a sensitivity of 90.95%, specificity of 83.25%, and an average area under the curve (AUC) of 0.8605, indicating strong diagnostic performance. Reliability was confirmed with a high Cronbach’s alpha of 0.893, signifying excellent internal consistency. Inter-rater reliability was assessed using intraclass correlation coefficients (ICC), which showed moderate agreement among raters, improving from 0.324 in Phase 1 to 0.399 in Phase 2 following a six-week reassessment interval.
Conclusion: The new causality assessment scale improves upon previous tools by enabling more accurate and efficient evaluation of device-related adverse events, enhancing patient safety. While it shows high sensitivity and specificity, its accessibility to stakeholders would be better supported by usability testing.
Keywords: Medical devices, Causality assessment, Safety

Introduction: Despite the increasing use of dental devices in clinical practice, underreporting of dental device-associated adverse events (DDAEs) remains a global concern. Materiovigilance systems are often underutilized in dentistry although they are essential for patient safety. Understanding the barriers that hinder reporting is critical for strengthening these systems. However, limited data are available on these barriers.
Objective: To assess barriers to reporting DDAEs among dental professionals using a validated questionnaire.
Methods: A structured, cross-sectional survey was conducted among dental professionals in a tertiary-care dental hospital in southern India. A structured cross-sectional survey was conducted among dental professionals at a tertiary-care dental hospital in South India. A validated questionnaire, demonstrating strong internal consistency (Cronbach’s alpha = 0.89), comprised 20 items across four sections: Awareness and Knowledge (three items), Cognitive Barriers (6), System-level Barriers (5), and Organizational Barriers (6). The survey was administered to 100 dentists with minimum 1 year of experience, data were analyzed using SPSS version 29
Results: Key barriers to DDAE reporting included the lack of a dedicated materiovigilance coordinator (95%) in each department and insufficient training (98%) regarding the identification and reporting of DDAEs. Reporting complexity (70%) and clinical workload interference (76%) further hinder reporting. A significant proportion of normalized recurring device malfunctions were non-serious (61%), while others hesitated because of uncertainty in identifying reportable incidents (37%) or feared reputational harm (46%). Notably, only 18% found the reporting process to be easy, highlighting the need for streamlined systems and stronger institutional support.
Conclusion: This study identified critical barriers to DDAE reporting among Indian dental professionals. Addressing these issues through regular training, simplified reporting systems, and administrative support is essential to strengthen materiovigilance practices and enhance patient safety in dental settings in India.

Keywords: Medical Devices, Questionnaire, Materiovigilance