FDA reaches vague conclusion in debate over safety of paclitaxel devices
Two days of debate over the safety of paclitaxel-coated and -eluting devices have culminated in a nonbinding recommendation by the FDA to continue sales of such devices for peripheral artery disease (PAD) patients, though the agency is also urging regulators to push for better long-term clinical data than is currently available.
The safety of paclitaxel devices has been a point of contention for months now, after a February correction in Circulation inverted the results of the 2016 Zilver PTX trial, finding the study’s five-year mortality results were “inadvertently reversed” to reflect a long-term survival benefit with paclitaxel-eluting stents compared to percutaneous transluminal angioplasty for PAD patients.
The corrected study, which observed a significantly higher mortality rate in patients treated with the paclitaxel stents, threw the safety of related therapies into question. Still, the FDA stuck with its initial position that the benefits of paclitaxel devices continue to outweigh the risks as long as the therapies are used appropriately.
After two days of meeting with expert panelists, the agency’s stance remained largely the same. The Star Tribune reported the Circulatory System Devices Panel didn’t find any dose relationship with mortality or any pattern of adverse events that suggested a biological mechanism of action, but they pushed for better long-term data on the subject.
The panelists agreed paclitaxel device labeling should be updated to reflect potential risks to patients, at which point they and their physician can make the choice that’s right for them.
“I know there are high risk factors and I think the patient or the consumer has the right to be aware of the risk-benefit that they have,” registered nurse and FDA panel member Patricia Daigle said, per the Star Tribune. “But ultimately the choice should be up to the consumer.”
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After graduating from Indiana University-Bloomington with a bachelor’s in journalism, Anicka joined TriMed’s Chicago team in 2017 covering cardiology. Close to her heart is long-form journalism, Pilot G-2 pens, dark chocolate and her dog Harper Lee.