European regulators on Thursday recommended that patients with heart disease or leg pains-a possible sign of heart problems-should not take GlaxoSmithKline's 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.
