Avandia Freeze Proposed By Scottish Docs
Make a commentBy Ed Silverman // April 7th, 2008 // 1:00 pm
They say there is “no defense” for prescribing the controversial if widely used diabetes pill after warnings were issued that the drug shouldn’t be used in patients with heart problems, The Scotsman writes.
The consultants, who work in the National Health Service Greater Glasgow and Clyde area, recommend that new patients not be given Avandia, general practitioners should look carefully at those already taking the drug, and treatment stopped if any risk factors are found. One senior source told the paper that the consultants “felt very uncomfortable with its ongoing usage” and it was likely that GPs would be prevented from prescribing the drug.
Glaxo’s Avandia is used by 150,000 patients in the UK and it is estimated that 15,000 take it in Scotland, more than 3,000 of them in the Greater Glasgow and Clyde area. There are signs of other health boards introducing similar measures. The move follows a controversial analysis published in The New England Journal of Medicine in May suggesting Avandia may raise the risk of heart attacks by 43 per cent.
In January, the European Medicines Agency said the drug should carry extra warnings, including the fact that it must not be used in patients with acute coronary syndromes such as angina. However, a review of the whole class of drugs, known as glitazones, by the agency has concluded that the benefits of Avandia still outweighed the risks. But the methodology has been criticised, and other studies have suggested the risks are uncertain.
Despite this, the Glasgow doctors are making recommendations to the area drug and therapeutics committee (ADTC) that could lead to many patients being taken off the medicine. The ADTC will consider the recommendations at a meeting this month before producing guidance for all doctors in NHS Greater Glasgow and Clyde, Scotland’s largest health board.
The consultants’ concerns are revealed in the minutes of a meeting of the Managed Clinical Network for Diabetes in February, where they discussed the new guidance from the EMEA. “The consensus was that there was no defence for its use unless the goalposts changed in times to come,” the minutes read.
A senior source present at the meeting told The Scotsman that while some consultants thought Avandia should be withdrawn completely, the majority view was that doctors needed to look very closely at patients on the drug and decide whether they should continue with it.
“It is a case of looking carefully at the patients who are on rosiglitazone, making sure that it’s safe to use it. And if it is not safe at all, then stop it completely,” the source tells the paper. The expert thought it was likely the drug would be placed on a restricted formulary, meaning only specialist consultants could prescribe it. GPs would no longer be able to issue Avandia.
A spokeswoman for the health board said: “We are aware of the safety issues surrounding the drug including the recent correspondence from the EMEA, and prescribers have been kept fully up to date with the safety information.”
NHS Forth Valley said that since the initial study was published last May, it had told doctors that another drug, Actos, “should be used as the glitazone of choice for new patients.” Paul Beardon, head of prescribing management at NHS Dumfries and Galloway, said it was likely that Avandia would be withdrawn from its formulary in the next month.
A Glaxo spokeswoman told the paper that, “after an extensive review of the data, the European medicines regulatory agency concluded in October last year that the benefits of rosiglitazone (Avandia) in type 2 diabetes continue to outweigh its risks – in other words, that rosiglitazone is still of value in the treatment of patients with type 2 diabetes.
“A revision to the labelling for rosiglitazone – the information that serves as a guide for doctors about the appropriate use of this medication – was announced by the European medicines regulatory agency in January. The regulators did not make any recommendations to doctors about switching treatment.”
“GlaxoSmithKline believes that rosiglitazone remains a valuable medicine for many patients with type 2 diabetes and an important treatment option for doctors, when used appropriately, and that the decision about a patient’s treatment should be made by the doctor, in consultation with the patient and in line with the prescribing information.”