New systems for marking pharmaceutical products with black warning symbols are being forced through in the wake of what is being termed the ‘Mediator Scandal’. Following the report that the diabetes drug benfluorex (Médiator), produced by the Pharmaceutical Company Servier, causes heart disease and death, the EU say that drugs will now be better monitored to prevent any more cases.
Changes to existing EU legislation, “will tighten up the European system for picking up and evaluating potential problems with medicinal products in any EU member state.” The new rules, agreed between the European Parliament and EU ministers, will introduce an automatic emergency procedure, including an EU safety evaluation and possible EU-wide withdrawal if, for example, a member state were to withdraw a medicinal product from the market. This procedure would also be triggered if a company decided not to renew a marketing authorisation for safety reasons. Pharmaceutical companies also have to state explicitly whether any product withdrawals are done so for safety reasons. The aim is to determine whether the "commercial reasons" sometimes given by companies for withdrawing a product in fact mask safety concerns. 
The EU report that an update of EU pharmacovigilance rules was decided in 2010. However, in the light of the Mediator case, the European Commission subjected these rules to "stress tests", which revealed potential loopholes that still needed to be closed. "Mediator" (benfluorex) was authorised to treat diabetes but was also prescribed as an appetite suppressant. It was on the market for over thirty years and was licensed and sold in France, Portugal, Luxembourg, Greece, Italy and Spain. Although it gave rise to doubts from 1999 it was not withdrawn in France - its biggest market - until 2009. Estimates of the number of deaths related to Mediator vary widely.
According to a recent paper published by Pub Med, after a year of exposure to the drug, there is an almost three fold increase in the incidence of certain types of heart disease including valvular regurgitation along with evidence of valvular toxicity. Ref - NCBI
The European Medicines Agency will also have to set up a system to make sure that all new medicines and any medicines for which regulators have on-going safety concerns are labelled with a black symbol, to enable patients and healthcare professionals to clearly identify them.
Links:
Adopted texts will be available here (click on 11.09.2012)
Video recording of debate (10.09.2012)
Profile of rapporteur Linda McAvan (S&D, UK)
Legislative Observatory file (Regulation on Pharmacovigilance)
Legislative Observatory file (Directive on Pharmacovigilance)
