EMA says ‘no’ to Avandia

The European Medicines Agency (EMA) announced overnight that it has suspended marketing authorisations for the anti- diabetes medicine Avandia (Rosiglitazone) citing research data linking the drug to increased risk of heart attack and stroke.

The FDA responded by imposing a number of restrictions on the drug’s sale in the US, including demands for clearer labelling of safety concers on packaging.

Avandia is made by GlaxoSmithKline (GSK), which has so far faced more than 13,000 lawsuits concerning its allegedly adverse effects. GSK has so far agree to settle around 11,500 of these suits.

An investigation into Avandia earlier this month by the British Medical Journal is thought to be the straw that broke the camels back for the EMA, with its suspension ensuring that the drug will cease to be available in Europe within the next few months.

Avandia is only available in Australia to patients with type 2 diabetes whose blood glucose concentrations are inadequately controlled by other available means, with the PBS requiring a specific Authority.

The product also comes with the following box warning in Australia: ‘The use of Avandia is not recommended in patients with known ischaemic heart disease, particularly in those taking nitrates. Avandia has been shown to be associated with an increased risk of myocardial ischaemia (angina, infarction).’

Avandia has been a source of controversy ever since it came to market some 10 years ago, with the drug now seen to symbolise many of the worst aspects of the pharmaceutical industry, from questionable data to politics and unscrupulous corporate practises.

At its peak, Avandia managed annual sales of around $US2.5 billion in 2006, but have decreased markedly since then. Its patent expires in 2012.