EMA boosts transparency
June 1, 2012
THE European Medicines Agency
has entered a new era of greater
transparency, by commencing the
publication of suspected side effect
reports for medicines authorised in
the European Economic Area on a
new website: www.adrreports.eu.
“A side effect includes side effects
arising from use of a medicine
within the terms of the marketing
authorisation as well as from use
outside the terms of the marketing
authorisation, including overdose,
misuse, abuse and medication
errors, and those associated with
occupational exposure,” the EMA said.
The reports come from the EU
medicines safety database,
EudraVigilance, and are one of the
ways in which the EMA monitors the
ongoing risk vs reward of medicines.
The first round of publications
were released online this week,
and relate to around 650
medicines and active substances,
with each drug sporting a single
report which pulls together the
total number of individual
suspected side effect reports
submitted to EudraVigilance by
Member States and marketing
authorisation holders.
According to the EMA, the data
can be viewed by age group, sex,
type of suspected side effect and
by outcome.
“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,” the EMA said.
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