Historical Archive

Over 1 million adverse reactions reported in the EU in 2013

There were over 1 million reports of adverse reactions received in 2013 by the European Medicinal Agency (EMA), which published the second annual Eudravigilance Report completed for Parliament, the Council and the European Commission, relating to the period from 1 January to 31 December 2013. Eudravigilance recalls the Italian drug agency (AIFA), is a web-based information system that collects and angles. alleged adverse reactions to drugs authorized in the European economic space.  Data "essential to ensure continuous monitoring of drug safety by the EMA and the Member States".

Well, reports are on the rise: there were over one million in 2013, with an average of 88,474 per month, 26% more than in 2012. The greatest increase occurred within the EU, thanks to the joint effort of the Regulatory Agencies to encourage the reporting of suspected adverse reactions.

In particular, there was an increase in 52%, compared to 2012 of adverse reactions reported directly by patients. "This is due to a greater awareness on the part of public opinion of the importance" of not neglecting these problems, "thanks also to the new European legislation on pharmacovigilance, which has introduced the possibility of direct reporting by citizens".

Margherita Lopes – 08 May 2014 – PharmaKronos


Articoli correlati

Back to top button
Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco