With more than one million post-marketing adverse reaction reports recorded in 2013, Europe reached a new annual record for adverse event reporting. These data were published in the second released in April.
How the statistics have changed in the adverse reaction report
In 2013, reports submitted to EudraVigilance increased by 26% compared with the previous year. Patients made a particularly important contribution to this increase, submitting 30,614 reports, approximately 10,000 more than in 2012.
The number of reports analyzed by EudraVigilance is even higher because, in addition to the one million reports related to products already on the market, the database also collects approximately six million adverse reactions reported from clinical trials that were ongoing in 2013.
It should be noted that not all reports submitted to EudraVigilance result in a safety signal. The analysis of the reports received led to the prioritization and assessment of 100 safety signals by the Pharmacovigilance Risk Assessment Committee (PRAC), including 43 signals detected and validated by the EMA and 57 by the European Member States.