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UPDATE 1-EU experts add new warnings to Glaxo's Avandia

Thu Jan 24, 2008 11:55am EST
 
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LONDON, Jan 24 (Reuters) - European regulators on Thursday recommended that patients with heart disease or leg pains -- a possible sign of heart problems -- should not take GlaxoSmithKline's (GSK.L: Quote, Profile, Research, Stock Buzz) diabetes drug Avandia.

The European Medicines Agency also said in its decision to update Avandia's label that the drug must not be used by people having a heart attack or with conditions such as angina.

Sales of the once-popular medicine have been hit hard recently by a report linking it to heart attacks.

Concerns about the safety of Avandia were triggered in May by a U.S. analysis linking it to a 43 percent higher risk of heart attack.

Avandia was Glaxo's second-biggest drug in 2006, with worldwide revenue of 1.6 billion pounds ($3.2 billion), but sales have plunged since May, with revenue in the United States down 48 percent in the third quarter from the year-ago period.

In October, Europe's drug watchdog said prescribing information should be updated to include a warning that patients with heart disease should only be given the drug after a careful examination of their individual risk.

Further studies were also recommended. (reporting by Marc Jones; editing by Rory Channing)

 

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