Paclitaxel-Coated Stents and Balloons May Increase Risk Of Death, FDA Warns

While the U.S. government remains shutdown, federal regulators issued a warning on Thursday that indicates medical stents and balloons coated with paclitaxel could be linked to an increased risk of death. 

The FDA issued a letter to health care providers on January 17, announcing that the agency is investigating paclitaxel-coated balloons and paclitaxel-eluting stents used for the treatment of peripheral arterial disease (PAD). The safety review comes following a recent study that suggests the devices were linked to an increased risk of mortality.

The study was published last month in the Journal of the American Heart Association, and found an increased mortality rate among patients given the drug-coated devices to treat PAD when compared to patients given bare balloons and stents.

The devices are meant to treat lesions in the femoropopliteal artery, opening up the obstructed vessel. When coated with paclitaxel, the drug prevents scar tissue formation. The meta-analysis, conducted by researchers from Greece, did not indicate why the drug was increasing the risk of death for recipients.

The FDA announced it will evaluate this study and other available long-term follow-up data to determine if paclitaxel-coated products present any long-term health risks. Currently, the agency’s stance is that the benefits of these products outweigh the potential risks, but the FDA will issue more information to the public as it becomes available.

“This review will focus on causes of death, the paclitaxel dose delivered, and patient characteristics that may impact clinical outcomes. Additional statistical analyses will be performed to clarify the presence and magnitude of any long-term risks,” the agency states. “We are working with manufacturers of paclitaxel-coated balloons and paclitaxel-eluting stents to better understand this issue.”

In the meantime, the FDA is recommending that health care providers take a number of steps, including:

• Continued surveillance of patients implanted with paclitaxel-coated balloons and paclitaxel-eluting stents.
• Discussing the risks and benefits of all available treatment options for peripheral arterial disease with patients.
• Reporting any adverse events linked to the drug-coated balloons and stents to the FDA’s MedWatch Adverse Event Reporting Program.