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EMA puts reports of suspected adverse events online

New public website launches with side effect information on 650 approved medicines

EMA adverse event reports website

The European Medicines Agency (EMA) has launched a new website that gives the public access to information on suspected side effects for approved drugs.

At launch it only includes reports from medicines approved under the EMA's centralised procedure, but within a year the regulator aims to start including common drug substances used in nationally authorised medicines.

The adrreports.eu site goes live with information on around 650 approved medicines and active substances and features adverse event reports from the EU's EudraVigilance medicines safety database.

But the European regulator warns that information on the site “does not reflect any confirmation of a potential link between the medicine and the observed effect(s)”.

The new website is part of the Agency's continuing efforts to ensure EU regulatory processes are transparent and open, and a key step in the implementation of the EudraVigilance access policy, which the EMA has been working on for the last five years.

Outlining the policy last August, the EMA noted: “Public health concerns may materialise when medicines regulatory authorities proactively communicate possible risks to the general public.”

Launching the new website the EMA was at pains to stress that the information it is putting online through the new website relates to suspected, rather than actual, side effects.

The regulator also requires all users of the website to read and accept a disclaimer explaining how to understand the information before they view a web report.

“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.

It will include adverse event reports that originate from the use of a medicine within the terms of its marketing authorisation as well as when it's used outside its license. Such uses include overdose, misuse, abuse and medication errors, and those associated with occupational exposure.

The site will carry one report per medicine or active substance, with each report pulling together the total number of individual suspected side effect reports submitted to EudraVigilance by Member States and marketing-authorisation holders.

Site users can then view these aggregated data by age-group, sex, type of suspected side effect and by outcome.

Initially available only in English, the European regulator will shortly make adrreports.eu available in the remaining 22 official EU languages.

6th June 2012

From: Marketing

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