Safety signals assessed by the pharmacovigilance risk assessement committee: biologics vs conventional medicines

Abstract

The Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for medicines safety monitoring in Europe. Biologic drugs (BDs) have more recently been developed and reinforced the treatment of serious and chronic diseases. Because of their specificities, BDs have become a new challenge for pharmacovigilance. This work evaluates safety signals generated by PRAC for BDs vs. conventional therapy (CT) between September 2012 and December 2018 (819 signals). Normalizing the results by the number of molecules (INN) in each drug class we found the proportion of safety signals by therapy type to be 4 for BDs vs. 2.5 for CT. The System Organ Classes (SOCs) affected by safety signals triggered for BDs and CT were compared. The three most relevant System Organ Classes (SOCs) found to be related to CT signals are general disorders and administration site conditions (14%), skin and subcutaneous tissue disorders (7%) and gastrointestinal disorders (6%). Signals related to BDs are mainly associated with blood and lymphatic system disorders (14%), skin and subcutaneous tissue disorders (13%) and nervous system disorders (10%). During the study period safety signals for BDs were proportionally 1.6 higher than safety signals for CT.