FDA cites "potential safety issues" with Multaq and Effient
This article was originally published in Scrip
Executive Summary
The US FDA is investigating a "potential signal of serious risk/new safety information" relating to Sanofi-Aventis' Multaq (dronedarone) and congestive heart failure, as well as for Lilly/Daiichi Sankyo's antiplatelet therapy Effient (prasugrel) and cases of thrombotic thrombocytopenic purpura (TTP), according to the agency's latest quarterly list of safety probes. The signals were identified from the Adverse Event Reporting System (AERS) database between January and March 2010.