LONDON, England / The Guardian / Society / Diabetes / September 24, 2010
Regulators rule treatment could lead to heart attacks or strokes and that benefits no longer outweigh risks
Denis Campbell and Julia Kollewe
Around 90,000 British diabetes patients were warned against continuing to use one of the most popular treatments for their condition after regulators ruled it could lead to heart attacks or strokes.
Avandia has been linked with an increased risk of heart attacks and strokes. No further prescriptions will be issued. Photograph: Bloomberg/Getty Images
After a three-year battle with UK pharmaceutical giant GlaxoSmithKline, the European Medicines Agency (EMA) recommended that Avandia, or rosiglitazone, which is used by 2 million people worldwide, should no longer be used after growing concerns about its potentially damaging effects on patients. The benefits of the drug, which is used to control Type 2 diabetes, no longer outweighed its risks, the regulator ruled.
The decision means that no new prescriptions can be issued for it, and that no new patients can start receiving a drug once seen as a major breakthrough in tackling the disabling effects of diabetes.
Evidence linking Avandia to an increased risk of a heart attack or stroke has been building since 2007. GlaxoSmithKline has insisted that Avandia is safe but in July agreed to pay $460m(£304m) in damages to settle about 10,000 lawsuits in America linking its use to patients suffering serious medical setbacks.
"Avandia is going to be suspended throughout Europe from now – that is, it can't be prescribed," said a spokeswoman for the Medicines and Healthcare products Regulatory Agency (MHRA), the UK's drug safety watchdog, last night. "For those who are on it, healthcare professionals should review their treatment and switch them to another drug or drugs if necessary."
Professor Kent Woods, the agency's chief executive, said: "Patient safety is the top priority for the MHRA. Clinicians should review all patients currently on rosiglitazone and take appropriate action."
"The EMA no longer believe that Avandia is a safe treatment," said Simon O'Neill of the charity Diabetes UK. "We are recommending that people with diabetes taking Avandia get in touch with their healthcare team as a matter of urgency to discuss their treatment options.
"We would not advise them to stop taking their medication in the meantime even if they are experiencing adverse side effects, as it is very important that people with diabetes keep their blood glucose under control to prevent short- and long-term complications."
First used in 1999, Avandia works by controlling blood sugar levels through making patients more sensitive to their own insulin. But the MHRA pointed out that action was needed because diabetics already have an increased risk of having a heart attack or stroke.
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