Summary Wilson's disease is potentially treatable with pharmacological agents, including chelators that increase urinary copper excretion (D-penicillamine or Trientine) and zinc salts. Long-term use of D-penicillamine may result in a variety of adverse effects, including haematological disorders that can span almost the entire spectrum of haematology, including the coagulation system. There are very few cases noted with D-penicillamine-related pancytopenia. Here we report an interesting case of an adolescent girl who was diagnosed with Wilson's disease and started with D-penicillamine and continued for 1.5 years, when she developed drug-induced pancytopenia. Stopping the offender's drug use helped the girl to improve, and subsequently, she had to be managed with Trientine.

Summary Cisplatin and other ototoxic agents such as vancomycin, quinine, and carboplatin are widely used in medical treatments but pose a significant risk of ototoxicity. This literature review investigates the incidence, severity, and characteristics of drug induced ototoxicity of nine drugs listed in the Danish summary of product characteristics (SmPC's), where each was found to contain an unclear reference to ototoxic related side effect. The main objective was to identify patterns in ototoxic outcomes and assess the effectiveness of interventions aimed at reducing hearing damage. A systematic search identified nine clinical studies on ototoxic effects and four on preventive measures. Studies varied in design, ranging from retrospective reviews to randomized controlled trials, and included diverse patient populations, ages, and disease types. Data were extracted on dosage, type of ototoxicity, measurement methods, and statistical significance. Findings showed that cisplatin is consistently associated with dose dependent, often irreversible, bilateral hearing loss, with symptoms sometimes appearing weeks to months after treatment. Other agents like quinine and vancomycin presented more variable outcomes. Among preventive strategies, trans tympanic injections of N-acetylcysteine and sodium thiosulfate showed promising results in reducing cisplatin induced hearing loss, while oral antioxidants yielded limited effects. The review highlights methodological challenges, including heterogeneity in study design, limited follow up, and small sample sizes. There is also a possibility that additional relevant studies exist in other databases or under alternative search terms. Cisplatin presents the most well documented ototoxic profile, whereas the evidence for other drugs is either limited, variable, or lacking. These findings call for better harmonization between drug labelling and current clinical evidence, as well as improved monitoring and drug specific research to guide safer prescribing practices.

Summary Many breastfeeding women take medications, potentially exposing their infants to adverse drug reactions (ADRs) through human milk. This study aimed to describe suspected ADRs in infants due to medication transmitted via breastfeeding. Using an observational cohort design, we analyzed spontaneous reports submitted to the Danish Medicines Agency from July 2013 to June 2023, as recorded in the National Danish Adverse Drug Reaction Database. ADRs indicate suspected, not proven, associations between medications and adverse outcomes. In total, 64 ADRs were reported in breastfed infants: 53% were girls, 39% boys, and 8% with unreported sex, with over half aged between 1 month and 1 year. Serious ADRs occurred in 28% of cases, while 72% were nonserious. No fatalities were recorded. The most frequently reported reactions involved general disorders, gastrointestinal issues, skin disorders, and metabolic or nutritional disturbances. COVID-19 vaccines were the most frequently reported drugs. The low number of reports may reflect underreporting or a low incidence of ADRs, underscoring the need for further research and increased awareness.

Summary Tyrosine kinase inhibitors (TKIs) are essential in cancer therapy but increasingly linked to arrhythmias, including long QT syndrome (LQT), atrial fibrillation, and ventricular arrhythmias. This review synthesizes current evidence on the arrhythmogenic potential of TKIs across drug classes and targets. Literature was sourced from PubMed, Google Scholar, and regulatory data up to November 2024. TKIs such as endothelial growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), FLT3, breakpoint cluster region-Abelson murine leukemia viral oncogene homolog (BCR-ABL), vascular endothelial growth factor receptor (VEGFR), and Bruton's tyrosine kinase (BTK) inhibitors are associated with diverse arrhythmias. Mechanisms include ion channel inhibition (IKr, INa, ICa, L), disrupted calcium handling via SERCA2a and phospholamban, and suppression of PI3K/Akt signaling. Inflammatory pathways, notably S100A8/A9–TLR4–NLRP3 activation, further contribute to proarrhythmic effects. These findings emphasize the need for individualized risk assessment, close monitoring, and mechanistically informed clinical management to minimize cardiac toxicity.

Summary The global opioid crisis underscores the critical need for interventions to reduce prolonged opioid use after surgery. This article provides a structured template for randomized clinical trials designed to evaluate strategies aimed at minimizing long-term postoperative opioid use. Elements of the protocol include inclusion and exclusion criteria, intervention specifications, primary and secondary outcomes, randomization and data collection methods, and statistical analysis plans. Adverse drug reactions, which can range from mild side effects, such as nausea, constipation, and drowsiness, to severe health complications including respiratory depression, dependency, and overdose, are a significant concern with prolonged opioid use. By offering a framework, this template aims to guide clinical researchers in designing clinical trials that address long-term opioid overuse, reduce adverse drug reactions, and enhance postoperative care.

Summary This study investigates the adverse reactions observed in pulmonary medicine. We used data from the Adverse Drug Event Manager (ADEM) of the Capital Region of Denmark from 2013 to 2024. Antibiotic drugs were the most common causes of adverse reactions reported but with very different side effect profiles. We observed a wide range of signals related to angioedema and Angiotensin Converting Enzyme (ACE) inhibitors as well as interstitial lung disease and nitrofurantoin and methotrexate. These findings were aligned with existing literature. Although the system captured well known adverse drug reactions, it struggled to detect new safety signals.

Summary This protocol outlines a systematic review that aims to explore the adverse effects of testosterone exposure using Mendelian randomization studies. Testosterone plays an important role in numerous physiological processes, yet the causal relationships between testosterone levels and various health outcomes remain unclear, particularly in the context of testosterone therapy and anabolic-androgenic steroid misuse. Traditional observational studies are limited by confounding factors and reverse causality, while randomized controlled trials are challenging to conduct over the long-term. To overcome these limitations, this review will synthesize findings from Mendelian randomization studies, which use genetic variants as instrumental variables to infer causality between testosterone exposure and health outcomes. By focusing on Mendelian randomization methodology, the study seeks to provide insights into the long-term effects of testosterone on a wide range of health outcomes, including but not limited to cardiovascular health, cancer risk, metabolic conditions, and psychological disorders. Ultimately, this systematic review aims to provide a deeper understanding of the potential side effects of testosterone exposure, which may be relevant in the context of testosterone treatment or anabolic-androgenic steroid misuse.

Summary Antiamyloid therapies have sparked a new hope for a potential disease-modifying therapy for Alzheimer's disease. Antiamyloid therapy targets amyloid-beta, which is a key feature of the disease. However, adverse effects such as amyloid-related imaging abnormalities (ARIA) have raised significant concerns about the safety of these therapies. ARIA, which includes vasogenic edema (ARIA-E) and microhemorrhages or hemosiderosis (ARIA-H), is a common adverse effect to antiamyloid therapies. Patient-related risk factors for ARIA include carrying the APOE-ε4 allele and cerebral amyloid angiopathy (CAA). Drug-related risk factors for ARIA include higher drug doses, early initiation of treatment, and concomitant use of antithrombotic medications, all of which increase the likelihood of vascular disruptions. Management of ARIA involves regular MRI monitoring and possibly temporary or permanent discontinuation of therapy if adverse effects develop during therapy. A gradual dose titration is recommended to minimize the risk of ARIA. Although antiamyloid therapies have demonstrated efficacy in reducing amyloid burden, the clinical benefit remains at best modest and must be weighed against the risks of developing adverse effects such as ARIA.