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Federal panel probes safety concerns tied to drug-coated stents

Updated:
WASHINGTON (AP) _ A federal panel on Thursday tackled the question of whether the drug-coated stents used to prop open the arteries of about 3 million people in the U.S. pose a heightened risk that requires action.

At issue during the two-day meeting of the outside advisers was whether risks of clotting, heart attacks and death are higher for patients with the drug-coated devices compared with those implanted with older, bare-metal versions.

Boston Scientific Corp. and Johnson & Johnson, the two manufacturers with U.S. approval to sell the drug-coated stents, say the benefits of the devices outweigh their risks.

The Food and Drug Administration believes patients could face a small but significant chance of blood clots. The agency asked panelists Thursday for advice on how to understand and ultimately minimize any clotting and associated risks associated with the devices.

``It is important to note FDA does not regulate the practice of medicine. However, FDA is responsible for any use of a device that raises a public health concern,'' FDA medical officer Dr. Takahiro Uchida told the panel.

Some researchers believe clotting associated with the stents leads to an increased risk of heart attack and death _ a danger the FDA said is unknown. The agency does believe the clotting risk is real, however.

``Are you certain of that conclusion?'' asked panel member Dr. John Somberg of Rush University Medical Center in Lake Bluff, Ill.

FDA medical officer Dr. Andrew Farb said he was, after acknowledging the difficulty of acting on that information.

``When we have rare events in relatively small numbers, to come up with sweeping conclusions can raise issues,'' Farb said.

The FDA asked the panelists to consider whether to update the labels on the stents with new warnings or change guidelines on how long people should take anti-clotting drugs such as Plavix and aspirin following stent surgery.

Boston Scientific acknowledges a slight increase in clotting associated with its drug-coated stent, the Taxus. The company said it has seen no corresponding increase in heart attacks or deaths.

``At the end of the day, the things patients care about _ 'Am I more likely to be dead or have a major heart attack?' _ the answer is 'no,''' said Dr. Donald Baim, Boston Scientific's executive vice president and chief medical and scientific officer.

Johnson & Johnson said there is no significant difference in clotting, heart attack or death rates between its stent, the Cypher, and bare metal versions.

Both companies said use of the drug-coated stents reduces the need for follow-up surgeries to reopen clogged arteries when compared with bare-metal stents. That accounts for the widespread use of the drug-coated versions since their introduction in 2003. Today, more than 60 percent of the stents probably are implanted in higher-risk and other patients not studied before the devices gained FDA approval.

Multiple studies have suggested the risk of blood clots, heart attack and death rises in patients who stop taking Plavix earlier than now recommended. Some doctors recommend patients stay on it indefinitely until more is learned.

But FDA staff said it is unknown how long patients should take the drug, distributed by Bristol-Myers Squibb Co. and Sanofi-Aventis SA.

The FDA also seeks recommendations for research on the drug-coated stents on the market or pending approval. Both Medtronic Inc. and Abbott Laboratories hope to enter the more than $5 billion U.S. market for the drug-coated stents.
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