EMA publishes suspected side-effect reports online
EU countries and EMA release data on medicines in compliance with EudraVigilance access policy
The European Medicines Agency has begun publishing suspected side-effect reports for medicines authorised in the European Economic Area (EEA) on a new website.
The reports come directly from the European Union (EU) medicines safety database EudraVigilance, and are used by regulators to monitor the benefits and risks of a medicine once authorised.
EMA says the website is part of its continuing efforts to ensure EU regulatory processes are transparent and open and is a key step in the implementation of the EudraVigilance access policy.
The information published today (31 May) relates to approximately 650 medicines and active substances authorised through the centralised procedure, which is managed by the Agency. The data is presented in the form of a single report for each medicine or active substance. Each report pulls together the total number of individual suspected side effect reports submitted to EudraVigilance by EU countries and marketing authorisation holders. The data can be viewed by age group, sex, type of suspected side effect and by outcome.
Within the next 12 months EMA aims additionally to publish suspected side-effect reports for common drug substances used in nationally authorised medicines.
A side effect includes adverse drug reactions arising from the use of a medicine both within and outside the terms of the marketing authorisation, including overdose, misuse, abuse and medication errors, and those associated with occupational exposure.
All information on the website relates to suspected side effects, which may not be related to or caused by the medicine, and as a result, the published information cannot be used to determine the likelihood of experiencing a side effect or as an indication that a medicine is harmful.
All users of the website are asked to read and accept a disclaimer explaining how to understand the information before they view a web report.
During June, EMA will launch the website in the remaining 22 official EU languages.