News on pharmacovigilance
Here you can read news in the pharmacovigilance area. The section will primarily bring news about updated information on specific medicines/adverse reactions from the PRAC and CHMD committees of the European Medicines Agency (EMA), but we will also be writing news.
The content/news will be selected based on the following criteria:
- New updated information on specific medicines/adverse reactions from the PRAC and/or the CHMP – usually adjusted to Danish settings
- Medicine consumption – medicines with a particularly high consumption among the public
- The severity/frequency of the adverse reaction
- Topicality
- Media coverage
- Medicines requiring attention for whatever reason
- New medicines – medicines marketed within the past two years that are subject to stricter reporting requirements
The news are especially relevant for doctors and healthcare professionals, but could also be relevant for people who work with medicines (whether clinically, in the pharmaceutical industry or in the retail industry) or for anyone else wanting to receive the latest updates on adverse reactions of medicines/safety updates on medicines.
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Suspicion of rare eye condition from Ozempic use to be investigated further
| 16 December 2024 |
The Danish Medicines Agency will request the European Pharmacovigilance Risk Assessment Commit-tee, PRAC, to assess two new Danish register-based studies from the University of Southern Denmark. The studies point to a potential increased risk of a rare eye condition, NAION, in patients receiving the diabetes medicine Ozempic.
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Updated version of the Danish Medicines Agency's guidance on risk-adapted recording and reporting of adverse events in clinical trials is now available on the website
| 23 October 2024 |
The Danish Medicines Agency’s guidance on risk-based recording and reporting of adverse events in clinical trials on medicinal products under Regulation (EU) no. 536/2014 has been updated and version 2.0 is now available on the website, in both Danish and English. The guidance has been updated with further clarification on the requirements, if risk-adapted adverse event management is implemented. For an overview of the changes, please refer to the change log in the guidance document.