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Diabetes drug must be banned -- medics

A diabetes drug prescribed to tens of thousands of sufferers in Ireland should be withdrawn over fears it increases the chances of heart attacks and strokes, a regulator said.

The European Medicines Agency (EMA) said Avandia's benefits no longer outweighed its risks.

The EMA committee said marketing of Avandia should be suspended and no further prescriptions issued while the suspension is in place.

GlaxoSmithKline, which produces the drug, containing rosiglitazone, said it was given to a total of 109,000 people in 2009.

Prof Kent Woods, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), said: "Patient safety is the top priority and we have been constantly monitoring the situation regarding rosiglitazone.



RESTRICTED

"The suspension means that clinicians should review all patients currently on rosiglitazone and take appropriate action, according to the individual clinical situation, to change to another suitable treatment."

In a separate ruling, the US Food and Drug Administration also said access to the pill should be restricted. It said 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.

Dr Ellen Strahlman, GlaxoSmithKline'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."



strokes

GlaxoSmithKline says it "continues to believe" Avandia is an "important treatment".

But the MHRA said tests had shown there was an increased risk of heart attacks and strokes associated with the drug.

In July, the UK's Commission on Human Medicines (CMH) said the risks caused by 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 the 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."

hnews@herald.ie


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