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Avandia hit by further restrictions

Published on 25/01/08 at 05:03pm

GlaxoSmithKline has strengthened the safety warnings on its diabetes drug Avandia following recommendations from European regulators.

The drug was hit by a safety scare last May after concerns emerged over cardiovascular side effects and third quarter sales fell by nearly 40% as a result.

Most of the lost profits came from the US because in Europe Avandia has been contraindicated for use in people with heart failure since its launch in 2000, and the EMEA has continued to update its labelling.

Nevertheless the safety concerns prompted the European regulator's reassessment of GSK's drug and Takeda's rival treatment Actos (pioglitazone).

This concluded both could stay on the market, but recommended GSK strengthen the safety warnings for Avandia (rosiglitazone).

GSK's European medical director Dr Alastair Benbow said: "The EMEA has previously concluded that the benefits of rosiglitazone continue to outweigh its risks.

"The revisions to the rosiglitazone label resulting from this review will provide some additional guidance to physicians prescribing rosiglitazone."

The new labelling notes Avandia may be associated with an increased risk of myocardial ischaemic events and warns against its use in patients with ischaemic heart disease and/or peripheral arterial disease.

Avandia will also now be contraindicated in patients suffering from acute coronary syndrome.

The label changes apply all of GSK's Avandia franchise, including its metformin combination Avandamet and glimepiride combination Avaglim.

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