(329) Adverse Events of Drugs Used in Pain Therapies: An Analysis of Spontaneous Reports from Switzerland

Monday, August 26, 2024

8:00 AM – 6:00 PM CEST

Location: Convention Hall II

Presenting Author(s)

Lucia Gasparovic, MSc (she/her/hers)

PhD Candidate
ETH Zurich, Switzerland

Co-Author(s)

Andrea Michelle Burden, PhD

Professor
Swiss Fenderal Institute of Technology
Zurich, Switzerland
OS

Oliver Senn, MD

Institute of Primary Care, University of Zurich, University Hospital Zurich, Zurich, Switzerland, Switzerland
SM

Stefan Markun, MD

Institute of Primary Care, University of Zurich, University Hospital Zurich, Zurich, Switzerland, Switzerland
BQ

Boris B. Quednow, PhD

Experimental and Clinical Pharmacopsychology, Department of Psychiatry, Psychotherapy, and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Switzerland, Switzerland
SN

Stefan Neuner-Jehle, MD

Institute of Primary Care, University of Zurich, University Hospital Zurich, Zurich, Switzerland, Switzerland
TS

Thomas Stammschulte, MD

Pharmacovigilance, Safety of Medicines Division, Swissmedic, Swiss Agency for Therapeutic Products, Berne, Switzerland., Switzerland
SW

Stefan Weiler, MD, PhD

Pharmacoepidemiology group, Institute of Pharmaceutical Sciences, ETH Zurich, Zurich, Switzerland., Switzerland

Background: Pain therapies are prescribed to a significant proportion of the population and associated with adverse drug reactions (ADRs). The prescription of pain therapies requires careful consideration of their safety profiles in the context of patient-specific characteristics.

Objectives: The objective of this study was to describe ADRs associated with drugs used in pain therapies in younger and older adults in Switzerland.

Methods: A comprehensive search for individual case safety reports (ICSRs) from Switzerland related to drugs used in pain therapy (WHO Standardised Drug Groupings) between September 29, 1991 and December 31, 2022 was conducted in the WHO database VigiBase. Adults (≥ 18 years) with known sex and age (categories 18-74 vs. 75 years and older), were included in the analysis. Patient demographics, report characteristics, the reported drugs used in pain treatment and the corresponding reactions were analysed descriptively.

Results: A total of 17,228 ICSRs were analysed after exclusion of duplicates (n=1,243), cases with unknown age or sex (n=5,248), age < 18 (n=1,004) and pregnancy cases (n=638). Of these cases, 58% were female, and 24% were 75 years or older. The most frequently reported suspect drugs in younger and older adults were paracetamol (8% and 7% of all cases, respectively) and acetylsalicylic acid (7% and 21%). The third most frequently reported suspect drug was venlafaxine in younger adults (6%) and diclofenac in older adults (5%). Generally, serious ADRs were reported more frequently in older vs. younger adults: 69% vs. 54%, ROR 1.9 (95% CI 1.8-2.1). Of these serious ADRs, those resulting in hospitalisation or death were also each reported 1.9 times more frequently in older than younger adults (ROR; 95% CI hospitalisation 1.8-2.1; 95% CI death 1.6-2.3). Acetylsalicylic acid was the drug most frequently reported as suspect in the serious ICSRs resulting in death (34% and 15% in older and younger adults, respectively), with haemorrhages reported most frequently as the corresponding reactions. In younger adults paracetamol and morphine were involved in 11% and 7% of all serious ADRs leading to death, most frequently due to poisoning/overdose.

Conclusions: This comprehensive analysis underscores the substantial burden of ADRs associated with drugs used in pain therapies in Switzerland, especially in older adults. A deeper understanding of the safety profiles of ADRs of these drugs can guide healthcare professionals towards safer treatment choices or informed monitoring of patients treated with high-risk drugs.