Cardiovascular safety of strontium ranelate: real-life assessment in clinical practice

Excerpt

The balance between the benefits and the risks of any medical treatment, action for prevention, or diagnostic procedure lies at the heart of any clinical decision. In line with this, the European Medicines Agency (EMA) recently set up a series of Good Pharmacovigilance Practices to reinforce procedures for surveillance and reporting of adverse events with authorised medical products [1]. These new regulations are currently being applied throughout all EU member states. In this context, the safety of all centrally registered drugs is closely monitored by the EMA through a new committee, the Pharmacovigilance Risk Assessment Committee (PRAC), which was launched in October 2012. The procedures include regular submission of periodic safety update reports (PSURs). …