Swissmedic Vigilance News

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(7) MedDRA Medical Dictionary for Regulatory Activities Available from: https://www.meddra.org/ As accessed 2022-04–29. (8) European Medicine Agency: Important medical event terms list (MedDRA version 25.0), 8 March 2022, EMA/138127/2022. (9) Swiss Confederation, Federal Office of Public Health FOPH, COVID-19 Switzerland. Available from: https:// www.covid19.admin.ch/en/vaccination/persons. (10) Montano, D., Frequency and associations of adverse reactions of COVID-19 vaccines reported to pharmacovigilance systems in the European Union and the United States. Frontiers in Public Health, 2022. 9: p. 756633. (11) Cappelletti-Montano, B., et al., A comparative analysis on serious adverse events reported for COVID-19 vaccines in adolescents and young adults. Frontiers in Public Health, 2023. 11: p. 1145645. (12) Dutta, S., et al., Adverse events reported from the COVID-19 vaccines: A descriptive study based on the WHO database (VigiBase ® ). Journal of Applied Pharmaceutical Science, 2021. 11(8): p. 001–009. (13) Albalawi, O.M., et al., Analyzing the US Post-marketing safety surveillance of COVID-19 vaccines. Saudi Pharmaceutical Journal, 2022. 30(2): p. 180–184. (14) Medicinal product information search platform (AIPS), (electronic version). Swissmedic, Bern, Switzerland. Available at: http://www.swissmedicinfo.ch/. (15) Inokuma, Y. and R. Kneller, Imprecision in vaccine adverse event reporting and a methodological analysis of reporting systems to improve pharmacovigilance and public health. European Journal of Clinical Pharmacology, 2023: p. 1–14. Swissmedic Vigilance News | Edition 31 – November 2023 28
Kounis syndrome: A less familiar adverse drug reaction Tugce Akyüz 1 , Thomas Stammschulte 1 , Roger Hullin 2 1 Safety of Medicines Division, Swissmedic, Bern, Switzerland 2 Cardiology Department, Lausanne University Hospital (CHUV), Switzerland Introduction Early detection of adverse drug reactions by healthcare professionals is of the utmost importance for patient safety. Kounis syndrome is a little-known side effect, with a reported incidence of 4.33 cases/100,000 inhabitants, as based on 52 cases documented over a period of four years in a region of Greece numbering 300,000 inhabitants (1). In Switzerland, a total of three cases of Kounis syndrome have been reported to Swissmedic to date (2). Kounis syndrome is defined as the occurrence of an acute coronary syndrome accompanied by an allergic reaction. For this reason it is also known as “allergic angina pectoris syndrome”. In the pathophysiological background are mast cells (1), which are present both in the heart muscle tissue and in atheromas of the coronary vessel wall. (3–4). If these are activated, they release inflammatory mediators such as histamine, which can trigger spasm of the coronary arteries. If this persists, severe heart muscle cell damage may occur, which is associated with increased troponin levels (1). Risk factors for Kounis syndrome include a positive history of allergic reactions, arterial hypertension, diabetes mellitus, dyslipidaemia and nicotine abuse. Three forms of Kounis syndrome have been described (5): • Type 1 is the most frequent variant (72.6%), generally occurring in younger patients with a known diathesis for allergic reactions. Underlying this form is the triggering of a coronary spasm without coronary sclerosis; • Type 2 occurs in 22.3% of all affected patients and is characterised by coronary spasms in the presence of known coronary sclerosis. In these cases, inflammatory mediators can destabilise existing plaques and cause an acute myocardial infarction; • Type 3 occurs in 5.1% of all cases and is limited to patients who have undergone stent implantation, in whom stent thrombosis or stent restenosis occurs in the context of an allergic reaction. Kounis syndrome may be triggered by food, environmental factors or medicinal products (Table 1) (6). Swissmedic Vigilance News | Edition 31 – November 2023 29
Page 1 and 2: Vigilance News Edition 31 - Novembe
Page 3 and 4: In this edition 5 Editorial 6 Safet
Page 5 and 6: Editorial Dear Reader Recently, a r
Page 7 and 8: exposed to non-teratogenic drugs. D
Page 9 and 10: Results Between January 2022 and Ju
Page 11 and 12: Among those cases in which drug cau
Page 13 and 14: (7) Swissmedic. Drug-induced pancre
Page 15 and 16: hyperlipidaemia, diabetes, coronary
Page 17 and 18: when treated with IVT is high, all
Page 19 and 20: Febuxostat and azathioprine: A rare
Page 21 and 22: professionals for Imurek ® does no
Page 23 and 24: COVID-19 vaccines: Is the seriousne
Page 25 and 26: A total of 4,125 reports (37% of al
Page 27: proportion of serious cases (12, 13
Page 31 and 32: Conclusion Diagnosing Kounis syndro
Page 33 and 34: As an example, we calculated the RO
Page 35 and 36: In summary, Swissmedic would like t
Page 37 and 38: Update to the guidance document “
Page 39 and 40: Vaccinovigilance Valeriu Toma Safet
Page 41 and 42: Serious Medically important/Serious
Page 43 and 44: 140 130 120 110 Non-serious Serious
Page 45 and 46: Vigilance for veterinary medicinal
Page 47 and 48: Healthcare Professional Communicati
Page 49 and 50: 22.09.2023 Swissmedic approves Pfiz
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