FDA advisory panel warns against the off-label use of drug-coated stents

A US Food and Drug Administration Advisory panel has warned of the risks of the off-label use of drug-eluting coronary stents. These wire mesh tubes are used to prop up unblocked arteries and they can be either bare-metal or coated in drugs to inhibit reclogging, especially with scar tissue.

The FDA has not cleared drug-coated stents for use in patients with complications such as severe heart attacks or multiple blockages but the Agency estimates that as many as 60% of all such devices are used in these unapproved settings.

Panel chairman William Maisel said: "I think the panel would like to see the off-label use go down." The FDA, which usually follows the recommendations of its panels, could issue a label change or make a public announcement that could shrink the US market for drug-eluting stents, currently worth some $5.0 billion a year.