Swissmedic Vigilance News
Edition 31 – November 2023
Edition 31 – November 2023
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In this edition<br />
5 Editorial<br />
6 Safety of medicines and case reports<br />
6 Pregnancy outcomes after GLP-1 agonist exposure in early pregnancy<br />
8 Drug-induced pancreatitis: Assessment of ADR reports and review of the literature<br />
14 Sex differences in outcomes of intravenous thrombolysis in acute ischaemic stroke patients with<br />
preadmission use of antiplatelets<br />
19 Febuxostat and azathioprine: A rare interaction with severe consequences<br />
23 COVID-19 vaccines: Is the seriousness criterion “medically important” applied correctly in reports,<br />
and are there differences between reports from healthcare professionals and patients?<br />
29 Kounis syndrome: A less familiar adverse drug reaction<br />
32 Regulatory<br />
32 The masking effect in pharmacovigilance: A signal detection challenge amidst the COVID-19<br />
vaccine rollout<br />
34 Information for private individuals, healthcare professionals and the pharmaceutical industry<br />
regarding the reporting of adverse effects and the competent authority, depending on the<br />
suspected product<br />
36 Drug safety: <strong>Swissmedic</strong> requirements for the medical assessment of individual case reports will<br />
be adapted<br />
37 Update to the guidance document “RMP ICH E2E Information submission HMP”<br />
38 Statistical review 2022<br />
38 Pharmacovigilance: Human medicinal products<br />
39 Vaccinovigilance<br />
45 <strong>Vigilance</strong> for veterinary medicinal products<br />
<strong>Swissmedic</strong> <strong>Vigilance</strong> <strong>News</strong> | Edition 31 – November 2023<br />
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