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FDA eases concerns over drug-coated stent

WASHINGTON - The government moved to ease concerns Tuesday about deaths associated with a popular new drug-coated heart stent, saying it now appears the Cypher stent is no riskier than its competitors.

The Cypher stent is a tiny metal scaffold used in patients with heart disease. It props open a cleaned-out artery and, unlike other stents, emits a drug to reduce the chances the artery will clog again.

But that drug doesn't prevent a different risk posed by all stents: blood clots that form around the device and that can cause a heart attack.

Months after the Cypher began selling last spring, the Food and Drug Administration began warning about reports of those blood clots in Cypher recipients - totaling 360 cases, including more than 70 deaths.

Considering more than 260,000 Cypher stents had been distributed to U.S. hospitals, the risk of any problem was small.

Still, FDA blamed some cases on inappropriate use of the Cypher, such as doctors who chose the wrong size, or improper anticlotting medication. Cypher recipients must take anticlotting drugs for three months, longer than the mere two weeks prescribed for bare-metal stents.

Last month, the agency said it didn't know whether Cypher was riskier than ordinary stents or if publicity was spurring complaints.

The FDA answered that question on Tuesday, saying blood clots among Cypher recipients to date appear "within the expected rate for any stent" (www.fda.gov/cdrh/safety/cypher2.html)

CHICAGO - At least 19 people who had gone to a county fair in Ohio in 2001 fell ill with E. coli after the bacteria apparently spread through sawdust in the air at an exhibition hall - the first time researchers have connected an outbreak to a contaminated building.

Testing at the building in Lorain County found E. coli O157 in the rafters, the walls and the sawdust - in some cases 10 months after the fair.

The study was conducted by the Centers for Disease Control and Prevention and published in today's Journal of the American Medical Association.

Tainted food is the most common source of E. coli outbreaks, which cause an average of 61 deaths and 73,000 illnesses a year in the United States. But people can also become infected from animal or human feces.

Altogether, 23 people who had attended the fair became sick with E. coli. Nineteen of them had gone to a dance at the hall or had otherwise visited the building, which contained exhibits of cattle, sheep, horses and dogs. The building had a clay floor covered with sawdust.

E. coli can cause fever, abdominal cramps and severe, sometimes bloody, diarrhea. Six of the infected were hospitalized. None died.

Researchers suggested not using sawdust, providing soap and water and disallowing eating near animals.

Since the study, the CDC has learned of two other outbreaks that might have been caused by buildings, one at the University of Wisconsin, the other at the Lane County Fair in Oregon.