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.
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No evidence that menstrual disorders are triggered by COVID-19 vaccination
| 24 September 2021 |
The Danish Medicines Agency and the European Medicines Agency have reviewed cases of menstrual disorders reported as side effects after COVID-19 vaccination and have found no causal association.
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Status på behandlede indberetninger om formodede bivirkninger ved Vaxzevria (AstraZeneca), uge 36
| 09 September 2021 |
Lægemiddelstyrelsen har behandlet i alt 3.879 indberetninger om formodede bivirkninger ved Vaxzevria (AstraZenecas COVID-19-vaccine). De fleste er kendte og forbigående bivirkninger. Der er behandlet 11 tilfælde af anafylaksi. Tre tilfælde af det usædvanlige sygdomsbillede med lavt antal blodplader, blodpropper samt blødning vurderes at være relateret til vaccinen.
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Danish Medicines Agency investigates a case of inflammatory condition reported after COVID-19 vaccination
| 26 August 2021 |
In collaboration with the EMA, the Danish Medicines Agency is investigating whether the rare inflammatory condition of MIS-C, previously observed as an aftereffect of COVID-19 infection in children and adolescents, can also occur after vaccination. While no causality with the vaccine has been established, it cannot be excluded either.
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Status on reviewed reports of suspected side effects of the COVID-19 Vaccine AstraZeneca after vaccination of more than 140,000 Danes
| 25 March 2021 |
More than 140,000 Danes have been vaccinated with the COVID-19 Vaccine AstraZeneca. As of 23 March 2021, a total of 499 reports of suspected side effects of the COVID-19 Vaccine AstraZeneca have been reviewed. Most of these side effects are known and transient in nature. Eight cases of anaphylaxis have been treated. The drug regulatory authorities are presently investigating reports of the very rare and unusual symptoms of a low level of platelets, blood clots in small and large vessels and bleeding.
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Status on reviewed reports of suspected side effects of the COVID-19 Vaccine AstraZeneca after vaccination of more than 140,000 Danes
| 25 March 2021 |
More than 140,000 Danes have been vaccinated with the COVID-19 Vaccine AstraZeneca. As of 23 March 2021, a total of 499 reports of suspected side effects of the COVID-19 Vaccine AstraZeneca have been reviewed. Most of these side effects are known and transient in nature. Eight cases of anaphylaxis have been treated. The drug regulatory authorities are presently investigating reports of the very rare and unusual symptoms of a low level of platelets, blood clots in small and large vessels and bleeding.
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Danish Medicines Agency sends out updated letter to people who have received the AstraZeneca vaccine within the last 14 days
| 15 March 2021 |
Today, the Danish Medicines Agency has sent out an updated letter to people who have received the AstraZeneca vaccine within the last 14 days. The purpose is to increase awareness on the symptoms that people should react to.
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Drug regulatory authorities are investigating reports of blood clots after AstraZeneca vaccinations
| 11 March 2021 |
The Danish Medicines Agency together with the EMA and the other drug regulatory authorities in Europe have launched an investigation of the AstraZeneca vaccine after reports of blood clots in people given the vaccine. One report concerns the death of a person in Denmark. At present, there is no evidence to conclude that there is an association between the vaccine and the blood clots.
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Danish Medicines Agency expands capacity for safety monitoring of COVID-19 vaccines
| 10 February 2021 |
The Danish Medicines Agency and drug regulatory authorities around the world find themselves in a massive historic task of monitoring the safety of COVID-19 vaccines. Thousands of people have already been vaccinated in Denmark, and within a short period of time, the rest of the Danish population is expected to be offered vaccination against COVID-19. To ensure intensive and close monitoring of the COVID-19 vaccines, the Danish Medicines Agency is stepping up its capacity by recruiting more employees to process reports of suspected side effects.
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Final report on market dialogue regarding the acquisition of a future pharmacovigilance system
| 24 September 2020 |
The Danish Medicines Agency has published a report finalizing the market dialogue on the acquisition of a future pharmacovigilance system. The report contains the Danish Medicines Agency's conclusi
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Danish Medicines Agency initiates COVID-19 data analyses
| 27 March 2020 |
What is the drug consumption and medical history of Danish COVID-19 patients? And does the use of certain painkillers, including ibuprofen, affect the disease course of COVID-19?