At the end of 2010 the European Union agreed rules to ensure the safety monitoring of medicines available in Europe. The recent ’Mediator’ scandal in France has shown just how necessary pharmacovigilance rules are.
In recent weeks France has been rocked by a scandal concerning a number of deaths caused by a prescription medicine authorised as a lipopenic - a drug to lower fat levels in the blood. Later it was used for the treatment of overweight diabetics. ’Mediator’ was later discovered to have appetite suppressant qualities and was heavily over-prescribed by doctors whose patients wished to lose a little weight. Controversially, the drug stayed on the market despite a succession of warnings over its side-effects, which include heart valve disease and pulmonary hypertension. It is thought that as many as 2,000 people may have died from the severe Adverse Drug Reactions (ADR) incurred by their use of the drug.
Before it was taken off the market in November 2009, it is thought that approximately five million people had taken Mediator (and been reimbursed for the cost), making it among the 50 most prescribed drugs in the country. However, already in 1997 the drug was banned in the US and in Switzerland; with France following suit 12 years later. The European Medicines Agency warned in 2002 of the risks associated with the medicine, however the warnings went unheeded.
Reasons cited for this include the complex French regulatory system with no clear boundaries between a number of competing agencies, as well as concerns over the alleged close nature of ties between the French president and Jacques Servier - the head of Servier, France’s second largest pharmaceutical company.
Pharmacovigilance rules recently adopted by the European Union were developed in order to prevent the occurrence of regulatory failures in monitoring and decision-making on the safety of medicines, by improving the European pharmacovigilance database ’Eurdapharm’, ensuring good reporting mechanisms, and a clear system of declarations of interests for scientists advising the European Medicines Agency and National Competent Authorities on authorisation.
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