The European Medicines Agency has begun publishing suspected side effect
reports for medicines authorised in the European Economic Area (EEA) on a new
public website. The reports come directly from the European Union (EU)
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
authorised. The launch of the new website is part of the Agency's 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 published information relates to approximately 650 medicines and active
substances authorised through the centralised procedure, which is managed by
the Agency. 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 authorisation 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 authorised medicines.
A side effect (also known as an adverse drug reaction) includes side
effects arising from use of a medicine within the terms of the marketing
authorisation as well as from use outside the termsof 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. 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.
Medicines are an important part of modern healthcare, providing effective
treatments for many diseases and conditions. For a medicine to be authorised
for use in the EU the benefits of the medicine must always outweigh the risks. Today's launch also highlights the importance of side effect reporting and
pharmacovigilance in safeguarding public health within the European Union.
Side-effect reporting is a key element in ensuring the detection of new or
changing safety issues, and the Agency 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 EU
languages.