Category: 3. Business

Study design and participants

This study utilized a quasi-experimental, pre-test/post-test design to compare the learning outcomes of nursing students exposed to Simulated Clinical Immersion (SCI) against those in a traditional, lecture-based control group. This design was selected as a methodologically sound approach to assess the comparative effectiveness of teaching strategies where randomized controlled trial (RCT) allocation was deemed impractical due to logistical constraints within the academic curriculum. The target population comprised undergraduate nursing students. The final sample size was N = 128.

Sample size and power calculation

A formal power analysis was conducted a priori using (Specify the Software Used, e.g., G*Power) to determine the requisite sample size. Based on a moderate expected effect size (e.g., Cohen’s d = 0.50) observed in similar simulation-based education studies (Cite relevant prior studies here), with a statistical power (1−β) set at 0.80 and a significance level (α) of 0.05, the calculated minimum sample size was (Specify the required number, e.g., 102). The enrolled sample of N = 128 was therefore considered highly appropriate and sufficient to detect statistically significant differences between the groups.

Educational content and allocation

All participants received the same standardized didactic content on palliative care and end-of-life (EOL) principles for older adults prior to the intervention phase. This curriculum included: pain and symptom management, ethical and legal considerations in EOL care, and therapeutic communication with older patients and their families. This ensured equivalence in theoretical foundational knowledge across both groups.

Participants were assigned to either the intervention group (Simulated Clinical Immersion – SCI) or the control group (Traditional Lecture) via alternate allocation (Non-random assignment based on class section or enrollment order), aligning with the study’s quasi-experimental classification.

Measurement tools

Four instruments were administered as both pre-tests and post-tests to assess the core learning outcomes: knowledge, self-efficacy, and preparedness for EOL care. All instruments demonstrated high internal consistency in the current study.

Demographic data sheet

A researcher-developed demographic questionnaire was used to collect participants’ background information, including age, gender, prior exposure to palliative care, and previous experience with simulation-based learning. Content validity was confirmed through expert review by faculty specializing in palliative care education to ensure the clarity and relevance of the items.

EOL knowledge

The scale was adapted from Gellis et al. [11], to specifically target clinical knowledge in geriatric palliative care. While the original tool evaluated interprofessional team communication, the modified version focused exclusively on assessing knowledge related to EOL symptom management and ethical principles in older adults. The adapted questionnaire will be included in an appendix for transparency.

Clinical self-efficacy scale

This scale was adapted from two separate established tools to provide a comprehensive measure of students’ confidence in providing EOL care. The internal consistency of this adapted version in the current sample was confirmed by a high Cronbach’s α 0.91, supporting its reliability for this study’s context.

Simulation Effectiveness Tool (SET); The SET, developed by Elfrink et al. [12], assessed students’ perceptions of the simulation’s educational effectiveness. The tool includes 13 Likert-scale items addressing three key domains: learning outcomes, confidence building, and clinical relevance. The SET is a widely recognized and validated instrument for evaluating simulation-based learning. In this study, construct validity was maintained by ensuring item alignment with the goals of the SCI intervention. The tool yielded a Cronbach’s α of 0.89 during pilot testing, reflecting high internal consistency.

The pilot study used for initial testing of the instruments included a sample size of (N = 25) students. The internal consistency values (α) for all four instruments in the final N = 128 sample were consistently α > 0.80 confirming their excellent psychometric properties.

Ethical considerations

This study received approval from the Ethical committee of faculty of nursing at Zagazig University (Approval No. 130–2024), ensuring ethical compliance and protecting all participants’ rights. This approval, a testament to our unwavering commitment to upholding ethical standards, was crucial in the research process. Informed Consent: Participants were fully informed about the study and gave written consent before joining. It’s important to note that participation was entirely voluntary, and students had the right to withdraw at any time without any consequences, ensuring their security and control.

Intervention group: simulated clinical immersion (SCI)

The SCI experience was structured across three core phases (pre-briefing, simulation, and debriefing).

Simulation Scenario and Procedures. Each simulation session involved 8 students. 4 students acted as active participants (rotating roles such as primary nurse, communication lead, and assistant nurse), while 4 students served as active observers using a structured checklist and contributing to the debriefing phase. The scenario focused on a critically ill older adult presenting with an acute exacerbation of (Specify the clinical condition, e.g., advanced Chronic Obstructive Pulmonary Disease) requiring immediate symptom management and a goals-of-care discussion with the family. The session structure adhered to best practices in simulation reporting guidelines (Referencing Table 1 for healthcare simulation research).

Debriefing process

The debriefing session (approximately 30–40 minutes) immediately followed the simulation. It was led by faculty experts with specialized knowledge in geriatric care, EOL principles, and simulation-based learning. The process employed a structured debriefing model (Specify the model used, e.g., Plus-Delta or GAS) to facilitate student reflection and guided learning. Feedback was standardized across all sessions using a faculty checklist to ensure consistency in content, duration, and focus on the targeted competencies (e.g., pain assessment, ethical reasoning, therapeutic communication) regardless of the faculty member leading the session. The faculty instructors had an average of 7 years of experience in clinical nursing and 3 years of experience in simulation pedagogy.

Control group activities

The control group received only didactic, lecture-based instruction covering the identical learning objectives and theoretical content as the SCI group. The sessions included instructor-led presentations, assigned readings, and large group discussions but excluded any form of clinical simulation or high-fidelity experiential learning

Data analysis

Data were analyzed using SPSS version 26. Descriptive statistics summarized participant demographics, while independent and paired t-tests, along with chi-square tests, evaluated differences within and between groups. Effect sizes (Cohen’s d) quantified the practical significance of findings, interpreted using standard thresholds. Statistical significance was set at p < 0.05. The analysis revealed large effect sizes, underscoring the substantial impact of the simulation intervention on knowledge, self-efficacy, and perceived simulation effectiveness.

The latest take-home grocery sales in Ireland rose by 5.5% in the four weeks to 2 November 2025, according to our latest data. Despite prices continuing to rise, shoppers spent an additional €64 million on groceries and were out in-store more often over the four weeks, boosting overall sales by €5.8 million. 

Grocery price inflation is now standing at 6.06%, falling slightly from last month by 0.5%. Irish shoppers, however, are in full flow for the festive season as they start to stock up on seasonal favorites.

It’s that time of year again as Christmas ads light up our screens and supermarkets fill their shelves with festive fare, signalling that the countdown to the big day has begun. Shoppers are already getting into the spirit, spending an additional €8 million on boxed chocolates compared with last month.

Retailers are acutely aware of the financial pressures that many households are under right now, especially with this year’s Budget approaching, and are keen to show how they’re delivering value for money with a big focus on promotions. Nearly a quarter (22%) of all grocery sales are on promotion, up nearly 5.9% versus this time last year. Promotional activity typically intensifies in the lead-up to Christmas, so this is likely to persist well into December.

Shoppers seeking value and quality

Own label saw strong growth over the last 12 weeks, up 6.3%, with shoppers spending an additional €99 million on these ranges versus last year. Premium own label ranges continue to see strong growth, up 15.3%, with shoppers spending an additional €18.5 million on these ranges compared to last year.

Brands continue to grow behind the total market with growth slowing to 5.2% in the last 12 weeks, but Irish shoppers still spent an additional €85.4 million on branded products. 

Brands currently hold 48.2% value share of the total market, the highest share since February, showing how shoppers are more likely to treat themselves in the lead-up to Christmas. Own label holds 46.2% value share.

Shoppers are usually looking for both value and quality – not just the lowest price – particularly at Christmas. I think we all like to indulge a little at this time of year and, despite the ongoing cost-of-living crisis, many have managed to find a balance by choosing retailers’ premium own-label ranges as an affordable way to treat themselves.

Category increases included frozen fruit, low alcoholic drinks, hot beverages, confectionary sweets, chocolate, sweet spreads and savoury snacks, all of which grew ahead of the total market in the latest 12-week period.

Retailer and channel performance

Online continued to grow, at a significantly faster rate compared to last month, up 6.4% year-on-year to take 5.6% value share of the market. Shoppers spent an additional €13.1 million online during the period, helped by an influx of new customers who contributed €5.8 million to overall performance – more than double last month. Over 18% of Irish households bought their groceries online during this time. 

Dunnes holds 24.6% market share, up on the last 12-week period, with sales growth of 6.1% year-on-year. Larger and more frequent trips contributed an additional €26.2 million  to their overall performance. 

Tesco holds 23.8% of the market, with value growth of 7.7% year-on-year. Shoppers increased their trips to stores by 0.8%  and, together with new shoppers, contributed an additional €29.8 million to the grocer’s overall performance.

SuperValu holds 19.4% of the market with growth of 4.1%. Consumers made the most shopping trips to this grocer, averaging 24.1 trips over the latest 12 weeks. SuperValu recruited new shoppers to store over the latest 12 weeks which contributed an additional €11.4 million to their overall performance.

Lidl holds 14% of the market with growth of 9.6%, the fastest growth among all retailers once again. Lidl also saw shoppers pick up more volume in store, up 2.1%,  contributing an additional €9.5 million to overall performance. 

Aldi holds 11.2% market share, up 3.8%. Increased store trips and new shoppers drove an additional €9.9 million in sales.

Key Messages

What is already known on this topic

Drug-induced pigmentary changes are increasingly recognized but remain poorly characterized in large-scale surveillance studies. Previous literature has focused primarily on case reports or small series, and labeling for many implicated drugs is incomplete.

What this study adds

This FAERS-based pharmacovigilance analysis identified strong disproportionality signals linking numerous widely used drugs to skin hyperpigmentation and hypopigmentation. Several high-signal agents, including ribociclib and amlodipine, lack pigmentary warnings in their product labeling.

How this study might affect research, practice or policy

The findings support the need for enhanced dermatologic monitoring for high-risk drugs with pigmentary safety signals. Drug-induced pigmentary changes may indicate therapeutic repurposing potential in pigmentary skin disorders, warranting further translational research.

Introduction

Adverse drug reactions (ADRs), though increasingly prevalent and clinically impactful, remain underrecognized when presenting as skin pigmentary disorders, despite their visible manifestations and psychosocial consequences.^1,2 Drug-induced pigmentary changes account for approximately 20% of all cases of acquired pigmentation.³ The clinical heterogeneity and overlap of these pigmentary changes with common dermatoses-such as post-inflammatory pigmentation, melasma, or vitiligo-pose diagnostic challenges, often leading to misdiagnosis or delayed recognition. Drug-related hyperpigmentation and hypopigmentation are best managed by discontinuation or substitution of the culprit medication.⁴ Additional measures include rigorous photoprotection and topical agents such as hydroquinone for hyperpigmentation, whereas hypopigmentation may respond to topical corticosteroids or calcineurin inhibitors, phototherapy, or surgical techniques (eg, grafting techniques). Timely recognition of these manifestations is critical for mitigating drug-induced pigmentary sequelae.⁵

Drugs can induce pigmentary disorders via distinct pathways, resulting in either hyperpigmentation or hypopigmentation.⁶ Common drugs that lead to pigmentary changes include alkylating/cytotoxic agents, analgesics, antiarrhythmics, and anticoagulants.³ Drug-induced cutaneous hyperpigmentation is typically non–immune-mediated and arises through mechanisms such as melanin accumulation, drug deposition, novel pigment formation, and iron deposition. Melanin increase may result from melanocyte stimulation, drug-melanin complex formation, or inflammation, while vascular injury may lead to iron or pigment granule deposition within dermal macrophages.³ In contrast, drug-induced hypopigmentation is more often associated with immune-mediated or cytotoxic mechanisms that impair melanocyte function or viability. The principal pathways include decreased melanocyte density, inhibition of melanogenesis, and disruption of melanosome transport. Topical or intralesional corticosteroids may also cause localized hypopigmentation by suppressing melanocyte activity, typically near the site of application or injection, and often with partial reversibility.⁷

This study leverages the FDA Adverse Event Reporting System (FAERS)-the largest global pharmacovigilance database-to systematically identify drugs associated with skin pigmentary changes.⁸ Through an in-depth analysis of drug-related adverse event (AE) data from the FAERS database, this study aims to enhance clinicians’ vigilance and diagnostic awareness regarding drug-induced pigmentary disorders, thereby facilitating timely recognition and intervention in routine dermatologic practice. Moreover, identifying specific agents associated with pigmentary changes may offer novel insights for drug repurposing and optimization of therapeutic strategies in clinical pharmacology.

Methods

Data Source

This study was conducted between April and June 2025, with three investigators involved in the analysis of the FAERS dataset. This pharmacovigilance study was conducted based on data extracted from the FAERS, a publicly available database designed to support post-marketing safety surveillance for drugs and biologics. The FAERS database contains spontaneous reports of AEs voluntarily submitted by healthcare professionals, pharmacists, consumers, and other reporters. These reports provide detailed information on patient demographics, suspected medications, therapeutic indications, AEs, clinical outcomes, and other relevant clinical data. We utilized OpenVigil 2.1, a validated pharmacovigilance analytics platform (http://h2876314.stratoserver.net:8080/OV2/search/), to access and analyze the FAERS dataset. OpenVigil 2.1 performs data import, cleaning, and statistical processing directly on FAERS data and provides disproportionality analysis outputs, including the Reporting Odds Ratio (ROR). The version of OpenVigil used in this study contains AE reports from the first quarter of 2010 to the fourth quarter of 2024.⁹

Drug Identification

AEs were classified according to the Medical Dictionary for Regulatory Activities (MedDRA, version 24.0), using the Preferred Term (PT) level. We retrieved reports associated with two PTs: “skin hyperpigmentation” and “skin hypopigmentation”. To identify the suspect drugs related to these pigmentary changes, we extracted all reports containing these two PT terms in the AE. For consistency in drug naming, we standardized all drug entries to their generic names. Brand names were mapped to generics using the DrugBank database (https://go.drugbank.com). Reports with unidentified or ambiguous drug names were excluded after manual review.

Statistical Analysis

We conducted descriptive statistical analyses to characterize reports related to pigmentary disorders, including reporting year, patient age group, sex, country of origin, and the top five associated indications. The primary analytical method employed was disproportionality analysis–a widely accepted pharmacovigilance approach for detecting potential drug safety signals. Common disproportionality metrics include the ROR, Proportional Reporting Ratio, Information Component, and Empirical Bayes Geometric Mean, each based on distinct statistical assumptions and detection thresholds. In this study, we applied the ROR, a well-established and interpretable metric. ROR compares the odds of reporting a specific AE with a drug of interest to the odds of reporting the same AE with all other drugs in the database. A drug–AE pair was considered to yield a statistically significant signal if the lower bound of the 95% confidence interval (CI) for the ROR exceeded 1 and the number of reports was ≥3. Data processing, summarization, and visualization were performed using Microsoft Excel 2019 and R software (version 4.5.0).

Results

Demographic Characteristics

A total of 9594 hyperpigmentation-related AE reports were identified (see Table 1), with the majority from the United States (62.6%). The most common indications were psoriasis (5.9%) and magnetic resonance imaging (4.4%). The age distribution showed that most cases were in individuals aged 41–64 years. Hyperpigmentation-related AE reports peaked in 2023, as shown in Figure 1. A total of 2,397 hypopigmentation-related AE reports were identified (Table 2). Most cases involved individuals aged 41–64 years and ≥65 years. The top indications were malignant melanoma (13.8%) and hypertension (12.9%). The majority of reports came from the United States (46.5%), followed by Germany (13.3%). Reports steadily increased from 64 in 2010 to a peak of 352 in 2023, with a slight decline to 249 in 2024 (Figure 1).

Table 2 Clinical Characteristics of Reported Skin Hypopigmentation

Figure 1 Annual reporting trends of drug-induced skin pigmentation disorders in FAERS, 2010–2024. The Orange line represents annual reports of hyperpigmentation, while the blue line denotes hypopigmentation. Hyperpigmentation cases were consistently more frequent and exhibited substantial year-to-year variation. In contrast, hypopigmentation reports were fewer and showed a steadier trend over time.

Disproportionality Signals

A total of 5,329 hyperpigmentation signals were identified based on the ROR threshold. The top 50 drugs with the highest signal strength are summarized in Table 3. Gadolinium-based contrast agents, notably gadodiamide (ROR 83.42), antibiotics such as minocycline (ROR 115.66) and clofazimine (ROR 53.30), topical agents including bimatoprost (ROR 105.36) and adapalene (ROR 20.25), pigmentation axis modulators represented by setmelanotide (ROR 1506.82), antimetabolites like mechlorethamine (ROR 65.99), and targeted therapies such as ribociclib (ROR 60.20) demonstrated the strongest disproportionality signals. Notably, certain drugs, including dupilumab and capecitabine, lack labeling for hyperpigmentation risks in their package inserts.

Table 3 Top 50 Drugs for Signal Strength of Skin Hyperpigmentation

A total of 1,054 hypopigmentation signals were identified based on the criteria of ROR. The top 50 drugs with high signal strength are listed in Table 4. These drugs were categorized into four major pharmacological classes: anticancer and targeted therapies, such as ribociclib (ROR 60.20), which exhibited one of the highest signal strengths; topical corticosteroids and dermatologics, including triamcinolone (ROR 37.20); immunomodulators and biologics, represented by dupilumab (ROR 3.46) and secukinumab (ROR 3.47); miscellaneous systemic drugs, such as dimenhydrinate (ROR 44.55). Notably, the majority of these drugs do not include skin hypopigmentation as a documented ADR in their package inserts.

Table 4 Top 50 Drugs for Signal Strength of Skin Hypopigmentation

Among hyperpigmentation-related events, the most frequently reported agents were bimatoprost (n = 567) and dupilumab (n = 210) (Figure 2). For hypopigmentation, dupilumab (n = 84) and letrozole (n = 61) accounted for the highest number of reports (Figure 2). Notably, several agents appeared in both hyperpigmentation and hypopigmentation datasets, including dupilumab, secukinumab, triamcinolone, cholecalciferol, clobetasol, hydroxychloroquine, and prednisone.

Figure 2 Comparative frequency of drugs associated with skin hyperpigmentation (left) and hypopigmentation (right) in FAERS, 2010–2024. Orange and blue bars represent the number of reports for drug-induced hyperpigmentation and hypopigmentation, respectively. Drug names are ranked by report frequency within each category; numeric values indicate absolute counts. An asterisk (*) denotes drugs reported in both pigmentation directions.

Discussion

While prior research on drug-induced pigmentary disorders has primarily relied on systematic reviews or isolated case reports, our analysis fills a crucial gap by utilizing large-scale pharmacovigilance data. Our findings reveal that reports of drug-induced hyperpigmentation were significantly more frequent than those of hypopigmentation. This discrepancy may stem from intrinsic mechanistic differences—hyperpigmentation often arises through more direct and common biological pathways,³ whereas hypopigmentation tends to involve rarer and more complex mechanisms—as well as from external reporting biases, such as variations in clinical visibility and diagnostic attention.⁷ Furthermore, inappropriate or excessive use of certain drugs, particularly those associated with long-term or high-dose exposure, may further widen the disparity between hyperpigmentation and hypopigmentation reports. The observed temporal pattern differences may partly reflect baseline reporting effects, with hyperpigmentation showing greater variability and hypopigmentation appearing relatively stable due to its lower baseline reporting frequency.

Among hyperpigmentation cases, females were disproportionately represented compared to males, whereas hypopigmentation exhibited no significant gender difference. This observation aligns with previous literature indicating a female predominance in drug-induced hyperpigmentary disorders, potentially attributable to estrogen’s stimulatory effects on melanogenesis in human melanocytes and the synergistic interactions of elevated α-melanocyte-stimulating hormone levels with estrogen.¹⁰ Both hyperpigmentation and hypopigmentation were predominantly reported in middle-aged and elderly patients, likely due to pre-existing imbalances in melanin metabolism associated with chronological skin aging and cumulative photodamage. This age distribution is consistent with previous clinical studies, such as the series by Giménez García and Carrasco Molina, which reported a mean patient age of 63 years (SD = 16; range, 34–86 years), with half of the affected individuals being over 60 years old.¹¹

Among drugs associated with skin hyperpigmentation, minocycline, bimatoprost, and setmelanotide warrant particular attention based on their robust signal strength. Minocycline, a tetracycline derivative widely used for acne and other inflammatory dermatoses, showed a notably high signal for hyperpigmentation in our study (ROR = 115.66; n = 199). Previous studies have suggested that approximately 3–15% of patients receiving long-term, high-dose minocycline therapy (defined as >1.5 years and cumulative doses >70–100 g) may develop cutaneous hyperpigmentation. This occurs due to the dermal deposition of melanin–iron–minocycline complexes.¹² Four distinct clinical patterns have been reported, often mimicking sunspots or age-related hyperpigmentation, leading to underrecognition.¹³ Therefore, regular dermatologic monitoring is advisable in patients receiving minocycline treatment. Early recognition can help prevent progression, and clinicians should inform patients of this potential risk prior to long-term use.

Bimatoprost is a synthetic prostaglandin F2α analog commonly used in the treatment of glaucoma and eyelash hypotrichosis.¹⁴ In our analysis, bimatoprost was associated with a remarkably strong hyperpigmentation signal (ROR = 105.36; 95% CI: 96.01–115.62). Consistent with this finding, multiple clinical studies have reported periorbital and eyelid hyperpigmentation following long-term ocular administration of bimatoprost, typically emerging within 4–6 weeks of treatment.^14–16 Mechanistically, bimatoprost has been shown to stimulate melanogenesis by upregulating tyrosinase activity via activation of prostanoid FP receptors, leading to increased melanin synthesis and deposition, particularly in periorbital regions. This pigmentary effect is typically reversible upon drug discontinuation. Interestingly, this pharmacologic property has also prompted its off-label use in repigmentation therapy for localized vitiligo and hypopigmented scars, suggesting a potential role in pigmentary disorders beyond its approved indications.¹⁷

Setmelanotide exhibited the strongest signal for hyperpigmentation in our FAERS-based analysis (ROR: 1506.82), which aligns with published clinical data showing up to 61% of users developing visible skin hyperpigmentation.^18,19 Unlike post-inflammatory pigmentation, this effect appears to be a direct consequence of melanocortin receptor activation, especially MC1R (melanocortin 1 receptor),^20,21 offering a unique perspective on drug-induced pigmentation and highlighting a pathway potentially exploitable for therapeutic repurposing in pigmentary disorders.

In our disproportionality analysis, ribociclib emerged as one of the top-ranking agents associated with hypopigmentation (ROR = 60.20), despite the absence of any pigmentation-related AEs in its product labeling. Ribociclib is a selective cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor approved for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer.²² The pathogenesis of ribociclib-induced hypopigmentation remains uncertain. Although it does not directly target immune pathways, inhibition of the p16 INK4a/Cyclin D1–CDK4/6–retinoblastoma protein axis may disrupt melanocyte homeostasis. The absence of autoimmune history in reported cases suggests a mechanism distinct from classical vitiligo, though a noncanonical immune contribution cannot be excluded.²³

Our findings are consistent with prior clinical observations.^22,24,25 For example, Alexander et al reported vitiligo-like lesions in patients receiving CDK4/6 inhibitors, particularly ribociclib.²² Vitiligo-like lesions associated with ribociclib are typically resistant to conventional skin-directed therapies, with only mild repigmentation observed in isolated cases treated with ruxolitinib cream.²⁶ The poor treatment response of ribociclib-induced vitiligo-like lesions warrants deeper exploration of their mechanisms and clinical relevance.²⁷ This association raises important questions regarding the underlying mechanisms, including whether it involves immune modulation or melanocyte-targeted cytotoxicity. Further research is needed to elucidate these pathways and potentially inform therapeutic strategies for pigmentary disorders.

In contrast, triamcinolone, a mid-potency corticosteroid, also demonstrated a strong hypopigmentation signal (ROR = 37.20), which is consistent with known effects documented in the prescribing information. Corticosteroids are well-established inhibitors of melanogenesis, acting through suppression of tyrosinase activity, downregulation of microphthalmia-associated transcription factor, and reduced dendritic transport of melanosomes. Chronic use may also induce local skin atrophy and structural disruption, further exacerbating pigmentary loss. In a comparative study, intralesional triamcinolone was associated with hypopigmentation in 80% of patients and skin atrophy in 73.3%, supporting these mechanistic insights.²⁸ The concordance between FAERS data and clinical labeling in triamcinolone underscores the reliability of pharmacovigilance signal detection in capturing expected AEs.

Certain agents, including dupilumab, tretinoin, and clobetasol, exhibit bidirectional pigmentary modulation, manifesting as both hyperpigmentation and hypopigmentation. This observation highlights the complexity of drug-induced pigmentary changes, which are not always unidirectional and may involve intricate immunological, inflammatory, and melanocytic mechanisms—especially in the case of biologics that act through immune pathways. Moreover, factors such as patient ethnicity, underlying dermatologic conditions, and individual immune history may further influence the pigmentary response. Given this complexity, clinicians should be aware of the potential for both pigmentary outcomes when prescribing these agents, and patients should be appropriately counseled regarding these possible effects.

These findings highlight the need to strengthen post-marketing surveillance for agents with high disproportionality signals in the FAERS database, particularly those not currently reflecting pigmentary AEs in their prescribing information. Notable examples include ribociclib and amlodipine, which exhibited significant associations with hyper- or hypopigmentation but lack corresponding label warnings. Furthermore, for drugs frequently prescribed in chronic disease contexts, it is advisable to establish standardized protocols for routine dermatologic monitoring of long-term users, with a focus on early detection and documentation of pigmentary changes. This study also provides a foundation for future large-scale cohort studies or clinical trials to validate the causal relationship between drugs and pigmentary changes. Moreover, the identified agents may offer novel opportunities for drug repurposing, such as utilizing hyperpigmentation-inducing drugs in treating hypopigmentary disorders (eg, vitiligo).

Several limitations of this study should be acknowledged. First, FAERS data are subject to underreporting, reporting bias, and incomplete information, likely leading to an underestimation of actual AE incidence. Second, disproportionality analysis can reveal associations but not establish causality. Third, the absence of detailed clinical information—such as lesion morphology, outcome, or histopathology—limits mechanistic interpretation. Fourth, confounding factors such as polypharmacy and comorbidities may influence the observed signals. For instance, concurrent use of minocycline with photosensitizing agents may intensify hyperpigmentation, while hepatic, endocrine, or chronic inflammatory disorders can independently cause pigmentary changes. Finally, the exclusion of non-cutaneous pigmentary events (eg, ocular or nail involvement) may underestimate the overall pigmentary burden.

Conclusion

This pharmacovigilance analysis of the FAERS database from 2010 to 2024 identified a spectrum of drugs associated with hyperpigmentation, hypopigmentation, or both, some of which are not currently labeled for such risks. Disproportionality signals were particularly strong for some agents, including minocycline, ribociclib, and setmelanotide, underscoring the need for strengthened dermatologic monitoring, especially in long-term therapy. Drugs with bidirectional pigmentary effects—such as dupilumab, hydroxychloroquine, and clobetasol—were also identified in our analysis. Considering the odds ratios and analytical findings, the drugs implicated in either hyperpigmentation or hypopigmentation warrant further investigation to better elucidate their underlying mechanisms and clinical relevance.

Abbreviations

AE, Adverse Event; ADR, Adverse Drug Reaction; CDK4/6, Cyclin Dependent Kinase 4 and 6; CI, Confidence Interval; FAERS, FDA Adverse Event Reporting System; MC1R, Melanocortin-1 Receptor; MedDRA, Medical Dictionary for Regulatory Activities; PT, Preferred Term; ROR, Reporting Odds Ratio.

Data Sharing Statement

The data used in this study were obtained from the publicly accessible FDA Adverse Event Reporting System (FAERS), available at https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers. All data were fully de-identified by the original data provider. The datasets analyzed during the current study are available from the corresponding author upon reasonable request.

Ethical Considerations

This study is exempt from ethics approval according to Items 1 and 2 of Article 32 of the Measures for Ethical Review of Life Science and Medical Research Involving Human Subjects (China, February 18, 2023). These provisions stipulate that research may be exempt from ethics review when: (1) it uses legally obtained public data or observational data of public behavior without interfering with such behavior; and (2) it uses anonymized information data that does not contain identifiable personal information. As this study analyzed publicly available, de-identified data from the FAERS database, it meets both conditions above and therefore qualifies for exemption from institutional ethics review.

Acknowledgments

The authors would like to thank the US Food and Drug Administration for providing access to the FAERS database, which served as the primary data source for this study. The interpretations, conclusions, and opinions expressed in this work are solely those of the authors and do not represent the views of the FDA.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Funding

There is no funding to report.

Disclosure

The authors report no conflicts of interest in this work.

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14. Medeiros FA, Walters TR, Kolko M, et al. Phase 3, randomized, 20-month study of bimatoprost implant in open-angle glaucoma and ocular hypertension (ARTEMIS 1). Ophthalmology. 2020;127:1627–1641. doi:10.1016/j.ophtha.2020.06.018

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Continental will also highlight upholstery fabrics featuring staynu surface technology, which provides exceptional dirt resistance and ease of cleaning. Two key products in this category are skai Toronto EN, with a fine leather grain, and skai Tovega EN, featuring a microporous texture. Both materials are designed for indoor environments such as public spaces and hospitality areas, offering durability, resistance to disinfectants and a wide range of colors for versatile design options.

Commitment to more sustainable surfaces: skai Evida and Evida Fiber

As part of its sustainable product strategy, Continental will present skai Evida and skai Evida Fiber, two bio-based artificial leathers intended for indoor use. skai Evida consists of up to 80 percent renewable raw materials, while skai Evida Fiber reaches 90 percent, combining a natural look with durability and easy maintenance. Both products are vegan, phthalate-free and manufactured using CO2-neutral electricity.

Visitors to Metstrade are invited to explore the full range of skai materials at RAI Amsterdam, booth 11.404, and learn more about Continental’s commitment to quality, innovation and compliance in marine hospitality design.

What’s one thing that makes your job exciting or special?

My role connects directly to my lifelong passion for aircraft. I have the unique opportunity to contribute to the creation of systems that fly and serve critical missions. Knowing that the products I help develop and support are flying safely across the globe gives my work a powerful purpose. This connection between technical decisions and real-world impact makes my role both exciting and deeply fulfilling.

What inspired you to join Airbus?

I have always dreamed of contributing to aircraft development. At university, I worked with a multinational team designing unmanned aircraft, and one of our designs almost reached the finals of an international competition, sparking my passion for turning ideas into reality.

After graduation, I joined Airbus’ Sepang Aircraft Engineering as a Technical Service Engineer, where I worked on complex repairs, retrofits, and C-check deliveries. A mobility assignment to Airbus Helicopters Malaysia further expanded my role, giving me leadership responsibilities and exposure to engineering management, Part 21 design, and technical support knowledge.

I remain at Airbus because of its culture of trust and collaboration. The responsibilities and feedback from my managers and colleagues have been invaluable, and the opportunities to work on projects that enhance aircraft performance and safety keep me motivated and aligned with my dream.

Explain what you do in simple terms

I lead three engineering teams that oversee upgrades, conduct maintenance planning, and provide technical support for operators. My role ensures smooth coordination between teams, timely delivery of accurate engineering documents, and adherence to quality and safety standards. I review upgrade designs before assembly and ensure maintenance plans are complete with the right parts and tools, as well as helping customers add features and maintain helicopters without delays. In doing so, I contribute to Airbus’ mission of delivering reliable, safe, and efficient helicopters.

How does your role contribute to Airbus’ mission or the success of its products?

As Head of Engineering, I oversee retrofit design, technical support, and work preparation. The retrofit design team enhances the aircraft to support mission-critical operations and maintain safety compliance. Our technical support team collaborates closely with customers to resolve issues and ensure safe, reliable flight. The work preparation team plans and guides maintenance to ensure efficient MRO services. Together, we contribute to the safety, reliability, and satisfaction of our customers.

What’s the most innovative project you’ve worked on at Airbus?

One of my proudest contributions was delivering a cost-effective helicopter trainer fleet within tight budget and timeline constraints. Our team retrofitted an EC120-B with advanced avionics, including a Multifunction Display, satellite navigation, and digital communication systems. This minimalist flight deck simulated the avionics environment of larger helicopters, providing scalable pilot training while staying within budget and schedule. It was a privilege to be part of the team that delivered this innovative solution.

How has Airbus supported your career growth or personal development?

Throughout my career, I’ve been fortunate to work with managers who trust and empower me, offering guidance when needed. Airbus fosters a positive, inclusive culture where everyone is treated fairly and encouraged to take on new challenges. Collaboration and open idea-sharing across global teams help us achieve the best results.

As I’ve gained experience, I enjoy mentoring colleagues, offering the same support that helped me grow – always with respect and a positive attitude.

How has your career evolved since you joined Airbus?

I started at Airbus as a Technical Service Engineer, reviewing technical documents, creating clear work instructions, coordinating with stakeholders, and resolving production issues.

Later, I moved to Airbus Helicopters Malaysia as a Design Engineer, where I learned to anticipate production challenges, propose alternative solutions, and gained hands-on experience with industrial design and Part 21 certification.

With this background, I joined Technical Support, providing compliant, effective solutions to customers and deepening my understanding of airworthiness.

This experience prepared me to lead the Engineering department, where I now guide and support the teams with firsthand knowledge of each role.

What’s the biggest lesson you’ve learned as a leader?

The biggest lesson I’ve learnt as a leader is that growth comes from stepping beyond your defined role. Taking on broader tasks and decisions helped me earn trust and handle greater responsibility.

Leadership is not just about doing the job well, but balancing the needs of the team, company, and customers. It requires judgment; knowing when to push forward, when to compromise, and when to uphold quality standards, even when it’s challenging.

What’s your most memorable experience at Airbus? Why does it stand out?

Early in my Airbus career, during a B-check on an A320, a technician spotted overlapping rivets on a newly replaced stringer, which was a serious issue with no approved repair and tight time constraints. I quickly secured a replacement part from overseas, coordinated with logistics, and worked with management to adjust the customer’s schedule. Our team worked overnight and delivered the aircraft on time, flying the last flight out of Kuala Lumpur International Airport that same evening.

Though it felt like a routine recovery then, months later I learned the customer switched their main MRO provider to us. That experience gave me confidence in making decisive choices under pressure and showed me how clear priorities and teamwork can solve tough problems.

If you could give one piece of advice, what would it be?

Take ownership beyond your role. Real growth happens when you step outside your defined responsibilities – tackling complex problems, making broader decisions, and taking initiative in uncertain times. These actions build trust, create new opportunities, and often lead to greater impact than expected.

Which Airbus value resonates with you, and why?

Reliability. Trust is built through consistent, dependable actions – whether managing urgent aircraft recovery or leading engineering teams. Reliability means being present, making clear decisions, and following through, especially in uncertain situations where outcomes matter.

It also involves balancing practicality with maintaining standards and meeting the needs of the team, company, and customer. It’s not just about completing tasks, but doing so in a way others can always depend on.

How does Airbus support you in maintaining work-life balance?

Airbus supports my work-life balance by valuing productivity over rigid hours. While my role does not offer flexible schedules, the focus on delivering results within reasonable timeframes helps me manage responsibilities with clarity and purpose.

Colleagues across regions respect time zones, holidays, and personal commitments like parental leave or illness. Managers proactively arrange coverage to ensure continuity without undue pressure. This culture of understanding and coordination allows me to balance my career and personal life sustainably.

What motivates you to keep growing in your career?

I am inspired by the innovative products that Airbus creates, and I am driven to contribute meaningfully to their progress, helping ensure they continue to deliver value and meet evolving needs.

What 3 words define Airbus for you?

Innovative, collaborative, inclusive.

Study design and patient population

This retrospective cohort study reviewed the medical records of patients diagnosed with LD-SCLC who underwent CCRT between September 2010 and January 2022 at Chung-Ang University Hospital. The inclusion criteria were as follows: pathologically confirmed SCLC, administration of standard etoposide/cisplatin (EP) based CCRT, mediastinum included in radiation field, and availability of enhanced abdominopelvic CT images obtained less than two weeks before CCRT initiation and less than four weeks after treatment completion. Although post-treatment CT scans were intended to be performed within four weeks after CCRT completion, the actual timing varied in clinical practice. In our cohort, the mean interval between treatment completion and post-treatment CT was 2.5 months, with a median of 2.0 months (range, 0–9.0 months). All patients underwent thoraco-abdominal-pelvic CT, brain magnetic resonance imaging, and positron emission tomography-CT at baseline, and staging was reassessed according to the American Joint Committee on Cancer (AJCC) 8th edition TNM classification to confirm limited-stage disease. Bone marrow biopsy was not routinely performed. The exclusion criteria were as follows: lack of baseline or post-treatment imaging, administration of non-standard treatment regimens, or lost to follow-up within three months of treatment initiation. This study was approved by the Institutional Review Board of the Chung-Ang University Hospital (No. 2207-009-19426), which waived the requirement for informed consent due to the retrospective nature of the study.

Assessment of body composition

All abdominopelvic and thoracic CT scans used for body composition analysis were obtained with a standardized tube voltage of 120 kV, which is the institutional protocol at Chung-Ang University Hospital for both diagnostic and treatment-planning CT examinations. Body composition was assessed using CT at baseline, defined as within two weeks prior to CCRT initiation, and at post-treatment, defined as within four weeks after CCRT completion. Body composition analysis was performed using TeraRecon Aquarius iNtuition software (TeraRecon, Durham, NC, USA) to measure the skeletal muscle area (SMA), visceral fat area (VFA), and subcutaneous fat area (SCFA). These areas were automatically calculated from single axial CT slices at the third lumbar vertebra (L3) and fourth thoracic vertebra (T4), with both transverse processes visible. Areas were quantified based on predefined Hounsfield unit (HU) thresholds: SMA, −29 to + 150 HU; VFA, −150 to −50 HU; and SCFA, −190 to −30 HU [7]. In addition to absolute cross-sectional areas, the visceral fat area index (VFI) and subcutaneous fat area index (SFI) were calculated by normalizing VFA and SCFA to patient height squared (m²). The L3 SMI, which has been shown to correlate well with total body skeletal muscle mass, was calculated as the L3 SMA (cm²) divided by the square of the patient’s height (m²). L3 low muscle mass was defined as an L3 SMI < 49 cm²/m² for men and < 31 cm²/m² for women, according to criteria specific for Korean populations [8]. Patients were classified as having a high or low VFI and SFI using the mean baseline values as thresholds.

The cross-sectional areas of the thoracic skeletal muscles, including the pectoralis, intercostalis, paraspinal, serratus, and latissimus muscles were measured at the T4 level as described previously [9]. The T4 SMI was calculated by dividing the thoracic SMA (cm²) by the square of the patient’s height (m²). There is no established T4 SMI cutoff point for defining T4 low muscle mass; therefore, we divided the patients into quartiles according to the T4 SMI, and the lowest quartile was defined as the low muscle mass group, as described previously [9].

Body weight and height information were extracted from patient medical records. Body mass index (BMI) was calculated as weight divided by height squared (kg/m²), and patients were classified as underweight (< 20.0 kg/m²), normal (20.0–25.0 kg/m²), or overweight (>25.0 kg/m²). Body weight was measured within two weeks of the corresponding CT scan. Although the WHO classification defines underweight as a BMI < 18.5 kg/m², we applied a cutoff of 20 kg/m² based on prior studies in Asian and cancer populations, where this threshold has been associated with malnutrition, reduced treatment tolerance, and poor prognosis [10, 11].

Chemotherapy regimen

All patients received a standard EP regimen concurrently with thoracic radiotherapy. Cisplatin was administered at a dose of 25 mg/m²/day on days 1–3, and etoposide at 100 mg/m²/day on days 1–3, every 21 days. A total of four cycles were planned, and patients who tolerated treatment generally completed all four cycles. The treatment completion rate for concurrent chemoradiotherapy was 92.7% (51/55 patients); four patients discontinued chemotherapy early due to hematologic or non-hematologic toxicities but still completed radiotherapy.

Radiotherapy

All patients received definitive thoracic radiotherapy using either three-dimensional conformal radiotherapy or intensity-modulated radiotherapy. The total prescribed dose was 60 Gy, delivered in 30 fractions (2.0 Gy per fraction), once daily, five days per week. The mediastinum was included in the radiation field in all cases. All patients have completed scheduled thoracic radiotherapy. Prophylactic cranial irradiation was administered at the discretion of the treating physician after completion of CCRT.

Endpoints and clinical variables

The primary endpoints were the changes in body composition indices, including the T4 SMI and L3 SMI, VFI, and SFI from baseline to post-treatment, and the incidence of significant muscle loss. Secondary endpoints included changes in BMI and body weight, overall survival (OS), treatment response rate, and the association between skeletal muscle loss and prognosis. Tumor response was evaluated by applying the RECIST guidelines version 1.1 to CT scans acquired every six to eight weeks. Additional clinical and laboratory data included age, sex, Eastern Cooperative Oncology Group (ECOG) performance status scales, AJCC 8th edition stage group, chemotherapy regimen, serum albumin level, and survival status.

Statistical analysis

Data are presented as median (range), mean ± standard deviation, or number (percentage). Continuous variables were tested for normality using the Kolmogorov–Smirnov test. Paired t-tests or Wilcoxon signed-rank tests were used to compare baseline and post-treatment body composition parameters. Between-group differences were assessed using the Student’s t-test or Mann–Whitney U test for continuous variables and the chi-squared test or Fisher’s exact test for categorical variables. OS was defined as the time from the start of chemotherapy to the date of death from any cause and was estimated using the Kaplan–Meier method. Group comparisons of OS were performed using log-rank tests. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using the Cox proportional hazards model. Variables with P < 0.10 in univariate analysis were entered into multivariate analysis. All statistical analyses were performed using SPSS software version 25.0 (IBM Corp., Armonk, NY, USA); a two-tailed P-value < 0.05 was considered statistically significant.

Nicolas Sauvage plans to promote best practices in corporate venture capital by launching a certificate for CVC professionals.

Nicolas Sauvage, president of TDK Ventures, has been appointed as chair of the Global Corporate Venturing Leadership Society for 2026, taking over the helm from Bill Taranto and Arvind Purushotham.

Sauvage set up TDK Ventures, the investment arm of Japanese technology company TDK, in 2019 and has subsequently built a team with offices in Silicon Valley, London, Bangalore and Tokyo. It launched a third $150m fund last year, taking its total assets after management to $500m.

He is keen to use the chair position to explore ways to help develop the global CVC community, including bringing recognition and certification for industry practitioners.

Maija Palmer

Maija Palmer is editor of Global Venturing and puts together the weekly email newsletter (sign up here for free).

Indian private-sector firm Adani Power will set up a 3,200MW greenfield thermal power plant in the country’s northeastern Assam state.

Bombay Stock Exchange-listed Adani Power, India’s largest private sector power generator, will invest 480bn rupees ($5.42bn) to set up this ultra super critical power plant in Assam, the company said on 14 November.

Adani Power emerged as the successful bidder by offering the lowest tariff of Rs6.30/kWh in a tightly contested bidding process, it said.

The plant will be set up under the Design, Build, Finance, Own and Operate (DBFOO) model. Coal linkage for the power plant has been allocated under coal allocation policy of the federal government.

The project will have four units of 800MW each and will be commissioned in a phased manner between December 2030-December 2032, Adani said. Adani has a current operating capacity of 18.15GW from 12 thermal power plants and one solar plant and aims to reach a generation capacity of 42GW by 2032.

The project award coincides with India’s aim to boost its overall generation to power its economic growth and provide round-the-clock electricity to all households in coming years.

The award is also in line with India’s plans to add 80GW of new coal-fired generation capacity by 2032 to meet an anticipated growth in India’s power demand over the next decade. But bulk of these additions are expected to be based on domestic fuel, limiting prospects for imported coal.

The project, along with other under construction and existing power plants, could buoy domestic coal demand and absorb surplus supplies, at a time when state-owned coal producer Coal India (CIL) aims to bulk up its output.

CIL, which meets more than 80pc of India’s coal needs, plans to raise its production in the April 2025-March 2026 financial year to 875mn t, up by 12pc from the year earlier and lift it further to 1bn t in the 2026-27 financial year.

The coal producer also aims to further raise the output to 1.04bn t in 2027-28, 1.08bn t in 2028-29 and 1.13bn t in 2029-30. The plans are part of India’s efforts to meet most of its coal demand through domestic sources and reduce non-essential coal imports.

By Ajay Modi