January 17, 2019

Media Inquiries

  Angela Stark
  301-796-0397

“A critical part of our medical product safety umbrella are our tools for collecting and analyzing emerging data about potential new safety risks of devices in the postmarket setting. We’ve invested heavily in these capabilities, to achieve a robust system that can quickly analyze emerging risks, and give us the information we need to intervene to prevent harm to patients. Today, we issued such a communication to health care professionals about possible risks to certain patients with peripheral arterial disease being treated with a type of drug-containing balloon or stent. The identification of this risk, and our work to notify patients and providers, reinforces why post-market surveillance is so important and why our continued investment in these capabilities is a key part of our work to protect patients. In this case, the specific cause of the increased risk of death found in a recently published study is yet to be determined, but we’re reviewing all available information quickly and thoroughly and will communicate as soon as we know more. In the meantime, we urge health care professionals to carefully monitor patients with peripheral arterial disease who are using these devices,” said FDA Commissioner Scott Gottlieb, M.D. “Keeping Americans safe is our top priority, regardless of whether we are operating in a business as usual setting or not. Even though the agency is currently facing a lapse in appropriations, we’re continuing our important work to help ensure the safety of medical products, including medical device postmarket surveillance.”

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.

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 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.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.