The new and improved EudraVigilance, the European system for managing and analysing information on suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the EU, received more than 2 million reports of suspected side effects in 2018. This is an increase of 37% compared to 2017 which largely reflects that from November 2017 the national competent authorities and the marketing authorisation holders were required to report non-serious cases of suspected adverse reactions to EudraVigilance, having previously only reported serious cases.
This was also a key driver for the increase in the number of reports received from European patients and consumers through national authorities and marketing authorisation holders, which almost doubled between 2017 and 2018. Improvements in patient reporting also reflect efforts at national level to encourage patients to share information on side effects through information campaigns. These and other findings are summarised in EMA’s annual report on Eudravigilance.
According to the report, EMA reviewed more than 2,200 potential signals. This is information on a new adverse reaction or new aspect of a known adverse reaction that is potentially caused by a medicine and warrants further investigation. Almost 80% of these signals originated from monitoring the EudraVigilance database. Other signals were generated from clinical studies and scientific literature.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
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Pharmaceutical Microbiology