Glaxo fires back against Senate report, says it disclosed safety risks to FDA in 2005
By APWednesday, February 24, 2010
Glaxo defends handling of Avandia heart risks
WASHINGTON — GlaxoSmithKline is pushing back against a Senate report that accuses the company of downplaying the heart risks of its diabetes drug Avandia.
Glaxo says Senate investigators mischaracterized the company’s handling of the controversial medication in a report issued over the weekend.
The Senate Finance Committee report has reignited debate over the drug’s safety, and whether Glaxo should have alerted the public earlier.
Government regulators added a warning about potential heart attacks to the drug in 2007, but the scope of that risk is not fully understood.
Glaxo says it began looking into Avandia’s safety in 2005 and has steadily updated the government since then. The British drugmaker makes its case in a 30-page memo posted online.
