Swissmedic Vigilance-News-Edition 36

Adverse drug reactions (ADRs) remain a major public health concern, yet underreporting persists in hospitals due to time constraints and the complexity of documentation. Discharge summaries contain valuable safety information, but their free-text format hinders systematic review. As part of the QUADRATIC study, we developed and validated natural language processing (NLP) models to identify potential ADRs in Italian-language hospital discharge summaries from the Ente Ospedaliero Cantonale hospital network in southern Switzerland. The logistic regression model with bag-of-words representation demonstrated a high level of precision and interpretability, making it possible to rank documents by ADR likelihood. In the operational setting, the highest-ranked summaries will be presented daily to pharmacovigilance experts via a dedicated interface integrated into the electronic health record system, which will support review by highlighting predictive text segments. The model can be recalibrated using structured feedback, which will ensure alignment with clinical practice. The long-term objective is to support differentiation between potentially reportable and non-reportable ADRs on the basis of national legislation. By embedding interpretable artificial intelligence directly into the electronic health record workflow, this approach enhances case detection, supports expert decision-making and improves underreporting, demonstrating a practical, scalable model for hospital-based pharmacovigilance.

^{Roberta Noseda, Laura Müller, Raffaela Bertoli, Alessandro Ceschi} 

Immune checkpoint inhibitors (ICIs) are associated with potentially severe immune-related adverse events (irAEs). We present three patients who developed ICI-associated myositis with myasthenia gravis-like manifestations, including one with myocarditis. Electroneuromyography showed inflammatory myopathy.

1. A 75-year-old man with melanoma developed myalgia, muscle weakness, ptosis, diplopia, and hypophonia after one cycle of ipilimumab-nivolumab followed by two cycles of nivolumab. His condition gradually improved, with spontaneous resolution at five months.
2. A 95-year-old woman with sarcoma developed myalgia, muscle weakness, ptosis, diaphragmatic paresis, and myocarditis with third-degree atrioventricular block and heart failure after two cycles of pembrolizumab. Despite intravenous immunoglobulin (IVIG) and corticosteroids (CS), her condition deteriorated, resulting in a fatal outcome.
3. A 66-year-old woman with hepatocellular carcinoma developed myalgia and muscle weakness, with diaphragmatic paralysis after tremelimumab and two cycles of durvalumab. She required non-invasive ventilatory support and was treated with CS and IVIG. Her condition gradually improved.

ICI-associated myositis overlap syndrome typically presents early with heterogeneous features. Prompt recognition of this irAE, ICI discontinuation, and multidisciplinary management are key to achieving the best possible outcome.

^{Françoise Livio, Alex Vicino, Nicolas Etienne}

Fixed drug eruption (FDE) is a well-recognised cutaneous adverse drug reaction characterised by the recurrence of well-demarcated lesions at identical sites following re-exposure to the causative medication. Although typically localised and self-limiting, FDE may occasionally manifest in generalised or bullous forms, known as generalised bullous fixed drug eruption (GBFDE), which have the potential for significant morbidity. Early diagnosis is essential to ensure immediate discontinuation of the offending drug and to prevent possible complications. Numerous drugs have been implicated, e.g. antibiotics or NSAIDs.

This article provides a concise overview of the clinical presentation and pathophysiology of FDE, highlights its association with tetracyclines, and summarises the measures undertaken by Swissmedic to increase awareness among healthcare professionals and patients to ensure timely diagnosis and management.

^{Ursula Köberle, Tugce Akyüz, Frédérique Rodieux}

In Switzerland, the reporting of adverse drug reactions (ADRs) is a legal obligation for healthcare professionals. Under Article 59 of the Therapeutic Products Act (TPA) and Article 63 of the Therapeutic Products Ordinance (TPO), doctors, pharmacists and other professionals entitled to administer or dispense medicinal products are required to report serious or unexpected ADRs to Swissmedic. For submitting a report, the mere suspicion of a causal relationship is sufficient. ADR reports from healthcare professionals are the foundation of a functioning spontaneous reporting system. The Swissmedic reporting tool ElViS should be used for reporting. By reporting, healthcare professionals make an indispensable contribution to the continuous post-marketing monitoring of the safety of medicinal products.

^{Victoria Ahnert, Mario Sulser, Susanne Wegenast, Irene Scholz, Thomas Stammschulte}

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline E2D(R1) on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports” reached Step 4 – the adoption of the harmonised Guideline following finalisation of the expert working group’s document – of the ICH Process in September 2025. The Guideline then entered Step 5, the implementation phase of the ICH Process. The revised guideline provides updated definitions and standards for post-approval individual case safety reporting, as well as good case management practices. Where applicable, the guideline notes where regional or local regulatory requirements may vary and marketing authorisation holders (MAHs) should consider specific regional/local requirements. Implementation of E2D(R1) by ICH regulatory members is expected from late 2025 onward, with regional guidance to follow. Swissmedic is currently examining potentially impacted areas of local pharmacovigilance requirements. ICH has published the additional training material created by the expert working group to complement the revised guideline E2D(R1) and to support implementation.

^{Valeriu Toma} 

The 2025 risk management activities of the Safety of Medicines Division demonstrate the importance of systematic monitoring and targeted regulatory interventions in maintaining a favourable benefit-risk balance for medicinal products in Switzerland. The following summary highlights the key outcomes across signal management, PSUR evaluations, RMP reviews and new communication initiatives. 

Signal management 

• 153 safety signals evaluated, most triggered by international sources. 
• Most frequently affected therapeutic areas:  
  • ATC L (antineoplastic and immunomodulating agents) 
  • ATC N (nervous system) 
• Around three quarters of all evaluated signals required risk minimisation measures, mainly product information updates  
• 279 procedures were conducted with marketing authorisation holders to implement these measures. 
• 7 DHPCs/HPCs were issued to inform healthcare professionals about newly identified or critical risks. 

PSUR evaluations 

• 345 PSURs reviewed.
• 24 resulted in product information updates 

Risk Management Plans (RMPs) 

• 361 RMPs reviewed. 
• Adjustments requested when needed to Safety Specifications, Pharmacovigilance Plans or Risk Minimisation Measures. 

Communication initiatives 

• Launch of the monthly “Safety Update – product information updates”.
• Introduction of:
  • Red Safety Information symbol (for DHPCs)
  • Blue Safety Information symbol (for ordered information materials)
• Aim: To improve the visibility, consistency and recognisability of safety related information for healthcare professionals. 

^{Stephanie Storre, Nora Ruef} 

Swissmedic receives reports of suspected adverse drug reactions from various sources submitted in accordance with legal requirements. In 2025, a total of 15,022 reports were submitted to Swissmedic, comprising 10,208 initial reports corresponding to the reported suspected cases and 4,814 follow-up reports containing additional information. The analyses in this report were based on 8,981 initial reports after de-duplication and exclusion of reports not referring to 2025. 

Most cases (n= 7,951, 89 %) were reported primarily by healthcare professionals. One third of these reports were submitted to Swissmedic directly or via the regional pharmacovigilance centres, while two thirds were sent by the marketing authorisation holders. 

The age of the affected individuals ranged from 0 to 100 years (median: 59 years). Females accounted for 54% of cases, males for 39%, while sex was unknown in 7%. 

Swissmedic assesses individual case safety reports in collaboration with the regional pharmacovigilance centres in Basel, Geneva, Lausanne, Lugano, and Zurich. In total, 2,208 reports underwent in-depth evaluation by the regional centres in 2025. 

^{Irene Scholz, Thomas Stammschulte}