Center for Excellence in Drug Safety and Pharmacovigilance

Merck’s Potential Blockcuster Tredaptive Fails Phase III Hurdle – Leads to EMA Analysis

Merck’s Phase III program for Tredaptive comes to an end secondary to both safety and efficiacy concerns. For more information click here.

Updated Pharmacovigilance Publications

Several new pharmacovigilance publications have become available through Dec 2012. Check out the most recent articles references with links to stay on top of the most up to date PV references.      

January Pharmacovigilance Course Info Posted

Check our PV Education Page for more information.

European Medicines Agency publishes video explaining pharmacovigilance legislation

The European Medicines Agency has produced a video with an introduction to the new pharmacovigilance legislation. Watch Dr Peter Arlett, Head of Pharmacovigilance and Risk Management, talking about the new and improved tools for regulators in Europe to ensure that patients are not exposed to unnecessary risks when taking medicines. The new pharmacovigilance...

Synthetic opioids and arrhythmia risk: a new paradigm?

Expert Opin Pharmacother. 2012 Jul 10. [Epub ahead of print] Synthetic opioids and arrhythmia risk: a new paradigm? Schuller JL, Krantz MJ. Source University of Colorado School of Medicine, Division of Cardiology ,  Aurora Colorado ,  USA. Abstract The most commonly prescribed class of medications in the United States for chronic severe pain is opioid...