EMA boosts transparency with online publication of suspected side effects
The European Medicines Agency has begun publishing suspected side effect reports for medicines authorized in the European Economic Area (EEA) on a new public website: www.adrreports.eu.
The reports come directly from the European Union (E.U.) medicines safety database EudraVigilance, and are one of the many types of data used by regulators to monitor the benefits and risks of a medicine once authorized. The launch of the new website is part of the Agency's continuing efforts to ensure E.U. regulatory processes are transparent and open and is a key step in the implementation of the EudraVigilance access policy.
The initial information published relates to approximately 650 medicines and active substances authorized through the centralized procedure, which is managed by the EMA. Information on the website is presented in the form of a single report per medicine or active substance. Each report pulls together the total number of individual suspected side effect reports submitted to EudraVigilance by member states and marketing authorization holders. These aggregated data can be viewed by age group, sex, type of suspected side effect and by outcome. Within a year the Agency aims to additionally publish suspected side effect reports for common drug substances used in nationally authorized medicines.
A side effect, or adverse drug reaction, includes side effects arising from use of a medicine within the terms of the marketing authorization, as well as from use outside the terms of the marketing authorization, including overdose, misuse, abuse, medication errors and those associated with occupational exposure.
All information on the website relates to suspected side effects. Suspected side effects 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.
This launch also highlights the importance of side effect reporting and pharmacovigilance in safeguarding public health within the E.U. Side-effect reporting is a key element in ensuring the detection of new or changing safety issues, and the EMA continues to further strengthen its work with partners and stakeholders across Europe to ensure a robust system for safety signal detection.
In June, the Agency will launch the website in the remaining 22 official E.U. languages.