Sunday, December 3, 2006

NYT: FDA Probe of Coated Heart Stents

Article in the New York Times -- FDA Probes Safety of Popular Heart Stent, by the Associated Press.  An FDA panel is meeting on the issue next Thursday and Friday.  Here's an excerpt:

Millions of chest pain and heart attack sufferers thought they were getting a phenomenal medical advance when tiny coils that ooze medicine were placed in their arteries to keep them from squeezing shut again.

These gizmos, called drug-coated stents, worked so much better than plain old metal ones that 6 million people worldwide received them in the few years they have been available. It was a modern record for any medical device.

Now their long-term safety is in question.

Doctors think these stents may raise the risk of life-threatening blood clots months and even years later unless people stay on Plavix, an anti-clotting drug whose long-term safety in stent patients has not been established.

For additional coverage, see the Wall Street Journal article, FDA Panel to Review Risks of Drug-Coated Stents, by Anna Wilde Matthews; and the Chicago Tribune article, FDA panel to probe clotting, new stents, by Bruce Japsen.


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