A diabetes drug taken by up to 100,000 patients increases the risk of heart attacks and should be withdrawn on safety grounds, senior doctors say today. A report by the British Medical Journal says Avandia should never have been licensed in Britain because its risks outweigh its benefits. One UK expert has calculated that the drug may cause as many as 1,000 extra heart attacks a year in Britain.
Danger signs: Experts have called for Avandia to be withdrawn. One UK expert has calculated that the drug may cause as many as 1,000 extra heart attacks a year in Britain. The warning – which raises concerns about the way drugs are tested and regulated – comes three months after the committee responsible for drug safety in the UK called for the drug to be withdrawn. But despite it writing to GPs to alert them to the dangers, patients were not informed and tens of thousands of people are still taking the drug.
Experts stressed that patients should not stop taking medication without first seeing their doctor – but urged GPs to review the way they treated diabetes. Avandia was approved by the European Medicines Agency in 2000 to help reduce blood sugar in patients with type 2 diabetes, the form that usually strikes in middle and old age.
It became one of the best-selling drugs in the world, with global sales of more than £1.5billion. Here, doctors wrote out more than a million prescriptions for it last year at a cost of around £30million. Its manufacturer, GlaxoSmithKline, said ‘extensive research’ showed the drug was ‘safe and effective’.
The drug, which is also called rosiglitazone, has long been known to increase the risk of heart failure. However, recent studies have shown it may also lead to a small increase in the risk of heart attacks.
A BMJ investigation with the BBC’s Panorama has revealed that concerns about Avandia were raised in July by the Commission on Human Medicines, an advisory body to the Medicines and Healthcare products Regulatory Agency (MRHA).
The commission said the ‘risks of rosiglitazone outweigh its benefits, that it no longer has a place on the UK market’ and called for prompt action. At the time, the MRHA wrote to GPs, warning them to look out for dangerous side-effects and to consider alternatives. But doctors were told to carry on prescribing Avandia while a European probe into its safety was under way. The results are due later this month.
Diabetes expert Professor Edwin Gale told Panorama the drug should already have been withdrawn. ‘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,’ he said.
Clinical pharmacologist Dr Yoon Loke, of the University of East Anglia, estimated that the drug causes around 1,000 extra heart attacks and another 600 extra cases of heart failure a year. ‘Even if you restricted it to patients who don’t have heart failure you will still get patients who newly develop heart failure,’ he said.
Yesterday the BMJ said no new patients should be started on Avandia and called on doctors to consider alternatives. In July a U.S. safety committee recommended that the drug was safe enough to stay on the market.
The drug’s manufacturer, GSK, said in response to Panorama that ‘patient safety is our priority’. ‘We have carried out an extensive research programme, involving more than 50,000 patients, and continue to believe it is safe and effective when it is prescribed appropriately,’ it said.
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