There were over 1 million reports of adverse reactions received in 2013 by the European Medicines Agency (EMA), which published the second EudraVigilance Annual Report compiled for the Parliament, the Council and the European Commission, relating to the period from 1 January to 31 December 2013. EudraVigilance, recalls the Italian Medicines Agency (Aifa), is a web-based information system that collects, manages and analyzes reports of alleged adverse reactions to medicines authorized in the European economic area. Data "essential to ensure continuous monitoring of drug safety by the EMA and the Member States".
Well, reports are on the increase: they 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 by regulatory agencies to encourage 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".
