FDA Issues Letter About Paclitaxel Coated Balloons and Eluting Stents
Today the FDA issued a Letter to Health Care Providers about a recent publication in the Journal of the American Heart Association that suggests a possible increased risk of death at two years and beyond in patients with a type of peripheral arterial disease (PAD) who were treated with vascular balloons coated with a drug called paclitaxel or stents that release paclitaxel in the femoropopliteal artery in the leg, compared to patients treated with control devices (non-coated balloons or bare metal stents). Paclitaxel-coated balloons and paclitaxel-eluting stents are approved to treat obstructed lesions in arteries of the legs. The authors of the paper analyzed data from previously conducted randomized-controlled trials.
Today we alerted health care professionals about possible increased risk of death in certain patients with peripheral arterial disease being treated with a type of drug-containing balloon or stent. https://t.co/hcVUn0cXVI— Scott Gottlieb, M.D. (@SGottliebFDA) January 17, 2019
The letter recommends doctors continue to monitor patients who have been treated with these devices and discuss the benefits and risks of all available treatment options for patients with PAD. At this time, the FDA believes that the benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used as indicated. In addition, the agency encourages prompt reporting of adverse events or suspected adverse events experienced with these devices through its MedWatch reporting system.
The identification of this risk, and our work to notify patients and providers, reinforces why post-market surveillance of medical devices is pivotal and why our ongoing investment in these capabilities is a key part of our work to protect patients— Scott Gottlieb, M.D. (@SGottliebFDA) January 17, 2019
The FDA is currently evaluating available long-term follow-up data—including from studies that supported approval of the devices and other available data sets—to determine if there are any long-term risks associated with paclitaxel-coated products. The agency is also conducting additional statistical analyses to clarify the presence and magnitude of any long-term risks, and is working directly with manufacturers of these devices to better understand this issue.
The FDA will communicate publicly as more information becomes available.