GlaxoSmithKline revises Avandia label

GlaxoSmithKline is to revise the European label for its Avandia product.

The European Medicines Agency’s (EMEA) committee for medicinal products for human use conducted a review into thiazolidiones, including rosiglitazone last year and the results of that review have led the company to make changes to the Avandia label.

Dr Alastair Benbow, vice-president and European medical director of the firm, 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.”

Included in the revision will be information on new data suggesting that rosiglitazone could be associated with a higher risk of myocardial ischaemic events.

Although the risk has not been confirmed, the company will include information suggesting that as a precaution, rosiglitazone should not be used in patients with ischaemic heart disease.

GlaxoSmithKline has noted that these recommendations will be printed in the warnings and precautions section of the product label.

In related news, the firm has recently announced the creation of a new collaborative project with the Medical Research Council for research into the genes associated with common human diseases.