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Statin associated musculoskeletal symptoms (SAMS) are common adverse drug reactions reported by 20
The global expansion of travel and online supplement markets has eliminated traditional geographic barriers to toxic plant exposures. We report a case of a 42-year-old female presenting with digoxin-like intoxication symptoms, including nausea, vomiting, and hypotension. Electrocardiography revealed sinus bradycardia (51/min), first-degree AV block, and downsloping ST-segment depressions with reverse tick morphology. Upon further comprehensive anamnesis, the patient revealed the consumption of a weight-loss supplement labeled as "Tejocote root" (Crataegus Mexicana), purchased during a travel to the USA. Serum digoxin assays yielded conflicting results across different platforms. The patient was managed with supportive care, including fluid replacement and antiemetics. Bradycardia persisted for five days, with complete resolution of symptoms and ECG abnormalities by day nine. Subsequent forensic toxicological analysis using liquid chromatography coupled to high-resolution mass spectrometry (LC-HRMS) and DNA barcoding confirmed the presence of yellow oleander (Thevetia peruviana) in the supplement, with no detection of the advertised Crataegus mexicana. While standard toxicological screening panels do not include plant-derived cardiac glycosides, cross-reactivity in digoxin assays may aid early diagnosis. Clinicians should maintain high suspicion for exotic plant poisonings in patients presenting cardiac glycoside-like symptoms, particularly following use of imported or online-purchased supplements. This case underscores the critical importance of multidisciplinary collaboration in determining the root cause of intoxication and highlights significant gaps in current forensic analytical capabilities for detecting botanical adulterants with public health implications.
BACKGROUND:Reporting adverse drug reactions (ADRs) is essential for drug safety. In Switzerland, healthcare professionals are legally required to report serious and unlabelled ADRs, yet under-reporting remains widespread. We tested a novel method to increase reporting of ADR-related hospitalizations. METHODS:This retrospective observational study used ADR-indicative ICD-10 codes to screen admissions to four Swiss hospitals, identify suspected drugs and send individual case safety reports (ICSRs) of confirmed cases to Swissmedic. RESULTS:Participating hospitals previously reported ~18 ICSRs annually. During the study period (7/2023-12/2023), 200 ADR-related hospitalizations were reported following a review of 814 pre-filtered admissions. Most ICSR data were available in structured format: Median age of patients was 59 (interquartile range [IQR] 42-75); 87 (44%) males; median of two comorbidities (IQR 1-3); the three most frequent ADRs were 'K52.1 Toxic gastroenteritis and colitis' (11 [6%]), 'T42.4 Poisoning by benzodiazepines' (10 [5%]) and 'R11 Nausea and vomiting' (10 [5%]). Discharge reports contained free-text information on suspected drugs: More than half of ADR-related hospitalizations were caused by antineoplastics (45 [23%]), psycholeptics (38 [19%]), opioids and other analgesics (34 [17%]). The median time to screen a case was 1 min, 8 min to collect, compile and send data of confirmed cases. CONCLUSION:The approach successfully increased reporting of serious ADRs. The time investment for creating ICSRs might soon be rendered obsolete, as most data are available in structured format, and large language models are key to identifying suspected drugs in discharge reports.
BACKGROUND:In oncology, health-related quality of life (HRQoL) is along with overall survival a decisive clinical element in regulatory and clinical decision-making. Consequently, health authorities are increasingly interested in HRQoL data when evaluating new cancer treatments, as it promises to better capture patient-relevant outcomes. Although strongly encouraged by regulatory agencies such as the FDA, EMA and Swissmedic, the inclusion of HRQoL data in regulatory submissions by pharmaceutical companies remains sparse due to variability in data quality, reporting standards, methodological rigor, and operational constraints. METHODS:We retrospectively analysed 342 Swissmedic-approved oncology applications (2001-2020) to assess the volume, role, and trends of HRQoL data. For each application, we recorded HRQoL inclusion, domains based on the WHO framework, measurement instruments, and differences across document types and application categories. RESULTS:HRQoL data appeared in 216 of 342 reports (63.2%). Inclusion was higher for new active substances (69.4%) than indication extensions (59.6%). Physical health dominated (87.1% of applications), while psychological (20.2%), social (1.8%), and environmental (6.7%) domains were rarely reported. Of 216 applications including HRQoL, only 62 (28.7%) suggested a benefit, 8 (3.7%) demonstrated a clinically meaningful improvement, and just 2 (0.9%) were reflected in product labels. CONCLUSIONS:Although HRQoL reporting in Swiss oncology submissions is increasing, it is still mostly limited to physical health. Our findings suggest underreporting of more universal HRQoL domains and limited regulatory utility mostly due to incomplete information and underuse of HRQoL integration in the statistical analysis plan by pharmaceutical companies, issues that align with challenges documented across international agencies.
INTRODUCTION:Reporting adverse drug reactions (ADRs) is essential for detecting drug risks. Despite legal obligations in Switzerland, underreporting remains an issue. This study assessed practice, knowledge and attitudes towards the spontaneous ADR reporting system among physicians and pharmacists. METHODS:A nationwide cross-sectional survey was disseminated via professional associations to physicians and pharmacists in Switzerland. The 21-item questionnaire assessed reporting practice, knowledge, attitudes, information needs and improvement suggestions. Multivariable regression (odds ratios [ORs], 95% confidence intervals [95% CIs]) examined associations between participant characteristics and reporting habits. RESULTS:A total of 1108 participants (834 physicians, 274 pharmacists) were included. ADRs had been suspected by 589 (53.2%), and 562 (50.7%) had reported ≥1 ADR. Most participants rejected the notion that reporting is pointless (999, 90.2%). Although 716 (64.6%) were aware of reporting obligations, 477 (43.1%) perceived reporting as time-consuming and 270 (24.4%) reported legal concerns. About half indicated no lack of incentives (587, 53.0%) and no concerns regarding personal (580, 52.3%) or patient data protection (545, 49.2%). More than half desired clearer guidance on reportable ADRs (609, 55.0%) and 648 (58.5%) expressed interest in pharmacovigilance training. Reporting ADRs was independently associated with increasing age and training (ORs between 1.28 [95% CI: 1.15, 1.42] and 1.92 [1.32, 2.79]), whereas investing >10 min in reporting was associated with age ≥60 (OR 1.59 [1.07, 2.38]), training (OR 1.28 [1.14, 1.45]) and pharmacist status (OR 1.83 [1.34, 2.51]). CONCLUSION:The fundamental willingness to report ADRs despite a simultaneous lack of specific knowledge indicates a need for targeted information campaigns and training opportunities.
