Deaths Spur New Caution From FDA On Stent Use

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Deaths Spur New Caution From FDA On Stent Use

 

Associated Press

Thursday, October 30, 2003; Page A04

 

 

More than 60 patients who received a popular new drug-coated heart

stent have died, the government disclosed yesterday -- a surprising

increase since the last health warning about the device months ago.

 

 

 

 

The Cypher stent is a tiny metal scaffold used in patients with

heart disease. It props open a cleaned-out artery but goes beyond

other stents to emit a drug to reduce the chance the artery will

clog again.

 

But that drug does not prevent a different risk posed by

all stents:

blood clots that form around the devices and can cause a

heart attack.

 

Sale of Cypher stents began in April; in July, the Food and Drug

Administration warned

that it had received reports of blood clots in

34 recipients, including five who died.

 

Yesterday, the FDA issued a second warning: It now has more than 290

reports of blood clots, and in more than 60 patients, the device was

associated with death.

Those clots occurred up to 30 days after the

stent was implanted.

 

The FDA has also received more than 50 reports of allergic-type

reactions:

pain, hives, fever and problems with breathing and blood

pressure.

 

The FDA said some of those patients died, but it did not

say how many.

 

The cause of the problems has not been determined, the FDA said,

stressing that it does not know whether the Cypher is riskier than a

bare-metal stent.

In studies that led to the Cypher's approval, it

was found no more likely to cause blood clots than competing stents.

 

Some 260,000 Cypher stents have been distributed to U.S. hospitals

and 180,000 abroad, making the number of problems reported small in

comparison.

Some of the increase in reports since July is likely due

to increased publicity, FDA device evaluation chief Dan Schultz

cautioned.

 

Cypher maker Cordis Corp. is conducting a 2,000-patient study that

will track side effects. Enrollment is nearly complete, and data on

blood clots should be available by the end of January, Cordis said.

 

 

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