The regulatory confusion surrounding Avandia, also known as rosiglitazone, is revealed in two investigations released today that highlight concerns about the medicine given to people with diabetes to reduce excessive blood sugar levels.
The drug, made by GlaxoSmithKline (GSK), is prescribed to patients with type 2 diabetes who are not injecting themselves with insulin. There have been claims it increases the risk of heart failure and may also raise the possibility of heart attacks.
A BBC Panorama documentary broadcast tonight and a BMJ article published today question whether there has been a failure of the UK’s regulatory system. The BMJ article asks whether there was sufficient clinical evidence in the first place for the product to be licensed by the European Medicines Agency (EMA) in 2000.
In July the UK’s Commission on Human Medicines (CHM) advised the Medicines and Healthcare products Regulatory Agency (MHRA) to withdraw Avandia. The MHRA was told “that the risks of rosiglitazone outweigh its benefits and that it no longer has a place on the UK market.”
Rather than pass on the recommendation, the MHRA circulated advice to doctors that they should “closely follow the current prescribing advice regarding the use of rosiglitazone [for patients with heart conditions] and to consider alternative treatments where appropriate”.
Dr Yoon Loke, a clinical pharmacologist at the University of East Anglia, tells Panorama: “We would expect about 1,000 extra heart attacks and possibly about 600 extra cases of heart failure too as a result of using Avandia.” Another diabetes expert, Professor Edwin Gale, tells the programme: “How long do you wait, how important is it to be absolutely certain and at what point do you start saying this game isn’t worth it, people’s lives may be at risk, something should be done about it?”
The MHRA said it had not passed on the recommendation to withdraw Avandia because it would create confusion, and was awaiting a decision by the EMA.
The MHRA said: “There is … a risk that unilateral action taken at a member-state level can be overridden by the EC and that a member state would be required to return the product to its market.”
Prescriptions of Avandia have declined in recent years. The EMA is due to publish its findings on the drug later this month.
In response to Panorama, GSK insisted that “patient safety is our priority”. A company statement said: “We have carried out an extensive research programme, involving more than 50,000 patients, to analyse the safety and benefits of Avandia and continue to believe it is safe and effective when it is prescribed appropriately.”
Guardian.com