In January 2019, the FDA alerted healthcare workers to the “potential for increased long-term mortality after use of paclitaxel-coated balloons and paclitaxel-eluting stents to treat peripheral arterial disease in the femoropopliteal artery,” according to an archived statement.
Three months later, the agency said it “identified a potentially concerning signal,” and in June 2019, the FDA said the size of the signal should be approached with caution, archived statements say.
Peripheral arterial disease affects about 6.5 million Americans aged 40 and older, according to the CDC. It is plaque buildup in the arteries and the narrowing of blood vessels, which can make walking painful.
Among three trials of 1,090 patients with the disease, the mortality rate five years after diagnosis was 19.8 percent for those treated with paclitaxel-coated devices and 12.7 percent in people treated with uncoated products, the agency said in an archived letter to healthcare workers.
After reviewing more data and analyses, the FDA said paclitaxel-coated devices do not increase the risk of death. The agency continues to recommend clinicians report adverse events and monitor patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents.
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