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UPDATE 1-EU agency says already aware of Avandia heart risk

Wed May 23, 2007 9:33am EDT

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(Adds further comment from European Medicines Agency)

LONDON, May 23 (Reuters) - Europe's drug watchdog said on Wednesday it would look at a new study highlighting heart safety risks with GlaxoSmithKline Plc's (GSK.L) diabetes drug Avandia but said it had already taken such concerns into account.

A pooled analysis of dozens of trials by leading U.S. cardiologist Steven Nissen this week concluded that Avandia increased the risk of heart attack by 43 percent and cardiovascular death by 64 percent.

The European Medicines Agency, however, said it had taken action on this risk late last year by strengthening warnings on the medicine.

Reacting to the latest study, the agency said in a statement that patients were advised not to stop treatment and to discuss the medication with their doctor.

Some of the trials used for the new study included patients who were not treated in line with the European guidelines, it noted.

"The situation in Europe is a little bit different to the American situation because, in Europe, Avandia is contraindicated in patients with heart failure anyway and we have warnings about ischemia," an agency spokeswoman said.

"In addition, the majority of the studies looked at in the Nissen paper have already been assessed by the (the agency's expert) committee and, partly due to that, the SPC (summary of product characteristics) was updated in 2006."

((Reporting by Ben Hirschler; editing by Paul Bolding; email: ben.hirschler@reuters.com; Reuters Messaging: ben.hirschler.reuters.com@reuters.net; +44 20 7542 5082)) Keywords: GLAXO AVANDIA/EUROPE

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