Safety of Drug-Coated Stents SpotlightedDec 7, 2006 | AP
The two manufacturers of drug-coated stents used to prop open the arteries of about 3 million people in the U.S. say the devices' benefits outweigh their risks, even though patients could face a small but significant risk of blood clots.
The companies, Boston Scientific Corp. and Johnson & Johnson, are in the hot seat as the Food and Drug Administration begins two days of meetings on Thursday to discuss the clotting risks associated with the devices.
Some people believe that clotting leads to an increased risk of heart attack and death a danger the FDA said is unknown.
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.
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 to bare-metal stents. That accounts for the widespread use of the drug-coated versions since their introduction in 2003.
The FDA is looking to an outside panel of experts for advice on a wide range of questions on the drug-coated stents, including whether to update the labels with new warnings, identify patients for whom they are not appropriate and perhaps change federal recommendations on how long people should take anti-clotting drugs such as Plavix and aspirin following stent surgery.
The agency also seeks recommendations for research on drug-coated stents on the market or pending approval.
"This is a public health issue of great importance," FDA devices chief Dr. Daniel Schultz told reporters this week.
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.