Panel Recommends More Warnings About Drug-Eluting Stents
FDA should warn doctors and patients that the safety of drug-eluting stents has not been established for relatively high-risk patients, who account for the majority of stenting procedures, an agency advisory panel said Friday, the Washington Post reports (Stein, Washington Post, 12/9).
Drug-coated stents are designed to prevent scar tissue from forming in arteries after angioplasty. However, recent studies have suggested the devices might increase the risk of blood clots compared with bare-metal stents.
Drug-coated stents are approved by FDA for use in patients with simple artery blockages, but the agency estimates that at least 60% of procedures involving the devices are performed in patients with more complex conditions, such as heart attacks, multiple blockages requiring more than one stent or blockages in more than one branch of an artery.
FDA asked the advisory panel to examine the risks of blood clots, heart attack and death for approved and off-label uses of drug-coated stents compared with bare-metal stents. On Thursday, the panel said there is no conclusive evidence that drug-eluting stents increase the risk of heart attack or death when used within the scope of their FDA approval (California Healthline, 12/8).
After reviewing research on off-label use of drug-coated stents, the panel on Friday said that such use appears to raise the risk of blood clots, heart attack and death. The panel said it is unclear whether the increased risk is caused by the drug-coated stents or if it is a result of the poorer health of the higher-risk patients.
Until that effect can be determined, FDA should warn doctors and patients of the potential risks, the panel said (Washington Post, 12/9).
The panel also said that patients should take an anticlotting medication, such as Bristol-Myers Squibb's Plavix, and aspirin for at least one year after receiving a drug-coated stent. Currently, the label for J&J's Cypher stent recommends that patients take anticlotting drugs for three months, and the label for Boston Scientific's Taxus stent recommends use of the drugs for six months.
According to the New York Times, it is "unclear" how FDA will respond to the recommendations. The agency "cannot require the companies to recommend a drug program on their labels for an unapproved use of the device," and BMS "is not allowed to market the drug for off-label stent use," the Times reports (Feder, New York Times, 12/9).
In related news, the Wall Street Journal on Saturday examined how some cardiologists "already are changing the way they treat patients" with drug-coated stents. According to the Journal, such doctors are "rethinking when to use the devices and how to alter follow-up care." Some cardiologists are concerned about extended use of Plavix, which costs about $6 per day and can interfere with certain medical procedures (Winslow/Wilde Mathews, Wall Street Journal, 12/9).
APM's "Marketplace" on Friday included an interview with Heather Won Tesoriero, a reporter for the Wall Street Journal who has been covering the FDA panel's consideration of stent safety (Ryssdal, "Marketplace," APM, 12/8).
A transcript and audio of the segment are available online.