Warning over widely used diabetes drug
A widely used diabetes drug should not be issued to new patients after fears it increases the likelihood of heart attacks and strokes, a regulator said today.
The European Medicines Agency's (EMA) committee on medicinal products for human use decided Avandia's benefits no longer outweighed its risks.
The EMA committee said marketing of the product should be suspended and no further prescriptions issued while the suspension is in place.
Professor Kent Woods, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), said: "Patient safety is the top priority for the MHRA and we have been constantly monitoring the situation regarding rosiglitazone."
He said patients currently receiving the drug should have their treatment plans reviewed and changed where appropriate.
In a separate ruling, the US Food and Drug Administration said access to the pill should also be restricted.
It ruled new patients would only get a prescription for Avandia if they could not control their diabetes with other medications.
The drug was once the top-selling diabetes pill in the world but use plummeted after a 2007 analysis linked it to heart attack risks.
GlaxoSmithKline (GSK), which produces the drug, said the company continued to believe it was an important treatment.
Dr Ellen Strahlman, GSK's chief medical officer, said: "Our primary concern continues to be patients with type 2 diabetes and we are making every effort to ensure that physicians in Europe and the US have all the information they need to help them understand how these regulatory decisions affect them and their patients."
The MHRA said tests had taken place on Avandia, which contains rosiglitazone, and advice had also been sought from the UK's Commission on Human Medicines (CHM).
In July, the CHM said the risks of rosiglitazone "outweighed its benefits and that it no longer had a place on the UK market".
An MHRA spokesman said: "The CHM considered action should be taken promptly and ideally within the appropriate EU framework, and it is this process which has led to today's suspension."
Simon O'Neill, of health charity Diabetes UK, said: "We are recommending that people with diabetes currently 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, such as swollen ankles or breathlessness, as it is very important that people with diabetes keep their blood glucose under control to prevent short and long term complications."
He added: "We welcome that a decision has been made about Avandia so people can now be supported to change on to an alternative treatment. We would urge the EMA to make swifter decisions in the future to ensure patient safety."
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