FDA Panel to Examine Drug-Coated Stents

An outside panel of health experts will examine whether drug-coated stents used to prop open coronary arteries can produce sometimes fatal blood clots, the Food and Drug Administration said Thursday.

The announcement comes after two recent studies suggested a small but significant increase in the rate of heart attacks and death caused by blood clots in patients outfitted with the metal-mesh tubes. The stents slowly release drugs that help keep arteries unclogged.

The FDA said it continues to believe the stents are safe and effective.

However, the agency wants one of its outside advisory committees to examine whether further studies or changes to the labeling of the devices are needed.

So-called drug-eluting stents were introduced in 2000 as an improvement on bare-metal stents. Nearly 6 million people worldwide have the drug-lined stents. The two dominant drug-eluting stent makers are Boston Scientific Corp. and Johnson & Johnson. The FDA said it has met with both manufacturers in recent months.

The FDA also said it continues to monitor how long patients with the stents should take the drug Plavix and aspirin to reduce or prevent clotting.

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Food and Drug Administration: http://www.fda.gov/