Regulators in the European Union (EU) have suspended the sale of GlaxoSmithKline's (GSK) highly controversial diabetes blockbuster drug Avandia, while the US have imposed severe restrictions on concerns that the drug increased the risk of heart attacks in diabetic patients.
With both regulators yesterday announcing their individual regulatory decisions, the EU regulator the European Medicines Agency (EMA) suspended marketing authorisation for all rosiglitazone-containing drugs including Avandia and said that drug will be pulled from Europe within the next few months.
The US regulator the Food and Drug Administration (FDA) severely limited access to the drug. Patients in the US, who are under Avandia can continue taking the drug but will have to sign a consent statement acknowledging that they understand all the risks before they can buy the prescribed drug.
Doctors cannot prescribe Avandia to new patients unless they certify that they have exhausted all other remedies to control their blood sugar levels including Avandia's main competitor, Actos, made by Japanese drugmaker Takeda Pharmecuticals.
''Data from clinical trials, observational studies and meta-analyses of existing studies that have become available over the last three years have suggested a possibly increased risk of ischaemic heart disease associated with the use of rosiglitazone. Further restrictions on the use of these medicines in patients with ischaemic heart disease were introduced,'' said the EMA in a statement.
''The availability of recent studies has added to the knowledge about rosiglitazone and overall, the accumulated data support an increased cardiovascular risk of rosiglitazone. In view of the restrictions already in place on the use of rosiglitazone, the committee could not identify additional measures that would reduce the cardiovascular risk.
The committee therefore concluded that the benefits of rosiglitazone no longer outweigh its risks and recommended the suspension of the marketing authorisation of the medicines,'' it added.