Move towards better detection and EU-wide withdrawal of dangerous medicines

The adverse effects of medicinal products will be better monitored in future, to prevent the recurrence of cases like the French diabetes drug Mediator (benfluorex), which led to many deaths. Changes to existing European Union legislation, backed by the Public Health Committee on Tuesday, would trigger an automatic EU safety evaluation in the event of a safety alert about a medicinal product in any EU member state.

Mediator, made by French drugmaker Laboratoires Servier, was authorized to treat diabetes but was widely prescribed as an appetite suppressant. It was on the market for over 30 years, and caused between 500 and 2,000 deaths, showing the limits of the early EU pharmacovigilance system. It was authorized and sold in France, Portugal, Luxembourg, Greece, Italy and Spain, and gave rise to doubts from 1998, but was not withdrawn from France - its biggest market - until 2009.

Mediator case reveals gaps in EU rules