This from today’s Times:
US regulators have approved new “black box” warning labels for GlaxoSmithKline’s controversial diabetes drug Avandia.
The warnings, the strictest that prescription drugs can bear in the US, emphasise the drug may trigger heart failure and that patients should be monitored closely by their physicians.
The decision from the US Food and Drug Administration (FDA) follows a recommendation from an FDA advisory committee last month that proposed Avandia and Actos, another diabetes drug manufactured by Japan’s Takeda, should both carry the warnings.
GSK has agreed to comply with the black box order, which means that Avandia will carry a boxed warning with greater prominence than its existing notification.
However, the FDA will continue to review the risks associated with the drug, and will update physicians in the next few weeks.
Shares in GSK fell by 1.5 per cent to £12.43 in early trading.
GSK has seen US prescriptions of Avandia, its second-bestselling drug, slide by 40 per cent since the New England Journal of Medicine published a report in May claiming that the drug increased the risk of heart attacks by 43 per cent.
The report has been criticised by other scientists.
GSK is considering cutting or redeploying its sales force as sales of Avandia plummet. Last year Avandia contributed £1.4 billion to GSK’s total turnover of £23.3 billion in 2006.
The company currently employs 30,000 salespeople, including 9,000 in the US.