FDA Investigating Paclitaxel-Coated Balloons, Paclitaxel-Eluting Stents

Share this content:
FDA Investigating Paclitaxel-Coated Balloons, Paclitaxel-Eluting Stents
FDA Investigating Paclitaxel-Coated Balloons, Paclitaxel-Eluting Stents

FRIDAY, Jan. 18, 2019 (HealthDay News) -- The U.S. Food and Drug Administration alerted health care providers on Thursday that the agency is investigating the use of paclitaxel-coated balloons and paclitaxel-eluting stents to treat peripheral arterial disease (PAD) in the femoropopliteal artery because of a potentially increased mortality risk in the long term.

In a letter to peripheral interventionalists and vascular medicine physicians, the FDA referenced data from a recent meta-analysis published in the Journal of the American Heart Association. The analysis of randomized trials revealed a possible increased mortality rate at two years postoperatively in PAD patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents compared with patients treated with noncoated balloons or bare-metal stents.

Despite this investigation, the agency noted the benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used according to their indications for use. The FDA recommends physicians continue to follow patients who have been treated with the devices based on the current standard of care. The agency also recommends physicians discuss with PAD patients the risks and benefits of all available treatment options. Physicians should report any adverse events or suspected adverse events through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

To determine whether there are long-term risks, the agency is evaluating long-term follow-up data on paclitaxel-coated products, including data from studies that supported FDA approval of the products. Additional statistical analyses are also being performed to clarify the presence and extent of any risks.

More Information

Share this content:

is free, fast, and customized just for you!




Already a member?

Sign In Now »

Trending Activities

All Professions

Drug Lookup

Browse drugs by: BrandGenericDisease

More in Home

CDC: Progress in HIV Prevention Has Stalled in the United States

CDC: Progress in HIV Prevention Has Stalled in ...

Agency says effective HIV prevention, treatment not reaching those who could most benefit

AAAAI: Egg Oral Immunotherapy Shows Sustained Benefit in Children

AAAAI: Egg Oral Immunotherapy Shows Sustained Benefit in ...

All children with sustained unresponsiveness ingested concentrated and baked egg

Prenatal Vitamin Intake in Early Pregnancy May Cut Autism Risk

Prenatal Vitamin Intake in Early Pregnancy May Cut ...

ASD risk down for children whose mothers took prenatal vitamins during first month of pregnancy

is free, fast, and customized just for you!




Already a member?

Sign In Now »