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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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.