FDA to investigate potential risks of paclitaxel-eluting devices
The FDA announced it is analyzing data to determine whether there are any long-term risks conferred by paclitaxel-coated products used in patients with peripheral artery disease.
In a letter to health care providers, the agency also told clinicians to continue monitoring patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents in accordance with the standard of care, and to discuss with patients with PAD the risks and benefits of all available treatment options.
As Cardiology Today’s Intervention previously reported, a meta-analysis published in December in the Journal of the American Heart Association found that compared with controls, patients treated with paclitaxel-coated devices had a 68% increased mortality risk at 2 years and a 93% increased mortality risk at 5 years. After the study was published, the steering committees of the BASIL-3, SWEDEPAD 1 and SWEDEPAD 2 trials announced they would temporarily halt enrollment pending further investigation.
“The FDA is currently evaluating available long-term follow-up data to determine if there are any long-term risks associated with paclitaxel-coated products,” the agency wrote in the letter. “This will include an evaluation of long-term follow-up data from studies that supported approval of paclitaxel-coated balloons or paclitaxel-eluting stents in the U.S. and other available data sets. 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. We are working with manufacturers of paclitaxel-coated balloons and paclitaxel-eluting stents to better understand this issue.”
There are presently no plans to order products removed from the market or clinical trials stopped, according to the agency.
“Currently, the FDA believes that the benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used in accordance with their indications for use,” the agency stated in the letter.
Clinicians are encouraged to report any adverse events or suspected adverse events associated with the use of paclitaxel-coated devices to the agency via its MedWatch system.