A European Parliament committee has backed calls for action to improve the detection of potentially unsafe drugs and speed up action to take them off the market.
The Parliament’s all-party environment and health (ENVI) committee has adopted two reports by UK Social Democrat MEP Linda McAvan calling for urgent changes in the pharmacovigilance legislation, including empowering European Union (EU) member states to order a medicine to be urgently removed from shelves if its manufacturer or sponsor decides not to renew its licence due to safety reasons.
In December 2010, Parliament and the Council agreed to revise the EU’s pharmacovigilance legislation following the case involving Servier’s type 2 diabetes drug Mediator (benfluorex), for which adverse reactions including concerns about possible heart valve disorders were reported as far back as 1998. Despite this, drug was widely prescribed, particularly in France, and was not withdrawn from the French market until November 2009, at which times it was estimated to have been linked to 500-2,000 deaths. Read more