Continuous benefit-risk assessment of oral antidiabetics and safety-related regulatory actions

Abstract

The benefit-risk assessment of drugs has become a complex and dynamic process. The model has moved from a one-off marketing authorization to an ongoing life-cycle approach where decisions has to be made based on the information available at every given time point. Especially interesting is the case of antidiabetics, characterized in the recent years for the increasing number of drugs approved together with the emergence of safety concerns that have brought controversial cases to the medical, pharmaceutical and regulatory world. The aim of this thesis is to consider the benefit-risk assessment process of different novel oral antidiabetics and safety-related regulatory actions, identifying the factors and challenges surrounding this process and possible ways to address the problems identified. A literature research was performed using the databases MEDLINE and the Cochrane library for all scientific publications until July 2014, prioritizing systematic reviews and meta-analyses. Safety-regulatory actions were retrieved from FDA’s MedWatch, European Medicines Agency and the Medicines Evaluation Board. The controversial cases of the thiazolidinediones as well as the more recently approved GLP-1 analogues and DPP-4 inhibitors are presented. Together with the descriptive analysis, a graphical display of the use of the different drugs during the last years in the Netherlands and the safety-related regulatory actions taken by the authorities given the available evidence at that moment is shown.