Proposed new changes to existing EU legislation, backed by the European Parliament's Public Health Committee, would trigger an automatic EU safety evaluation in the event of a safety alert about a medicinal product in any EU Member State.
These changes would ensure that the adverse effects of medicinal products will be better monitored, to prevent the recurrence of cases like the French diabetes medicine "Médiator" (benfluorex), which led to many deaths.
"Médiator" (benfluorex) was authorised to treat diabetes but was widely prescribed as an appetite suppressant. It was on the market for over thirty years, and caused between 500 and 2,000 deaths, showing the limits of the early EU pharmacovigilance system.