The U.S. Food and Drug Administration (FDA) has updated a warning it issued earlier this year about the use of certain drug-containing balloons and stents in patients with peripheral arterial disease (PAD).
The warning now includes the agency's analysis of follow-up data from premarket trials and information from its June 2019 advisory panel meeting, and it updates its January 17 and March 15 notifications to healthcare providers.
Based on the FDA's review, it is recommending that healthcare providers do the following:
- Continue monitoring patients who have been treated with paclitaxel-coated balloons and paclitaxel-eluting stents.
- When making treatment recommendations, consider that there may be an increased rate of long-term mortality in patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents.
- Discuss with patients the risks and benefits of PAD treatment options.
- Consider that for patients at high risk for restenosis and repeat femoropopliteal interventions, the benefits of using a paclitaxel-coated device may outweigh the risk of late mortality.
- Ensure that patients receive optimal medical therapy for PAD and other cardiovascular risk factors as well as guidance on healthy lifestyles.
- Report any adverse events or suspected adverse events experienced with the use of paclitaxel-coated balloons and paclitaxel-eluting stents through MedWatch, the FDA's safety information and adverse event reporting program.
The FDA will continue to work with manufacturers and researchers on additional clinical evidence development to assess the long-term safety of paclitaxel-coated devices, as well as with manufacturers on labeling updates for paclitaxel-coated devices, it said.
