Drug-Coating Safety Risk Acknowledged At Cardiology Gathering, But Cause Remains Elusive
Executive Summary
Physicians and researchers in an all-day session at the Cardiovascular Research Technologies conference in Washington, DC, on March 5 largely backed the recent finding that paclitaxel-coated balloons and stents may be tied to a higher patient mortality rate. But the specific mechanism underlying the deaths remains unknown.
You may also be interested in...
FDA Panel To Address Paclitaxel Safety Concerns
The US FDA will soon hold a meeting to discuss paclitaxel-coated devices to treat peripheral arterial disease. The drug-eluting stents and balloons have been subject to increased scrutiny since a meta-analysis found they were linked to a higher patient mortality rate.
FDA Tells Providers To Limit Use Of Paclitaxel-Coated Stents
New US FDA analysis of paclitaxel-coated devices to treat peripheral arterial disease matches previous reports of an increased death risk tied to use of the devices. The agency is encouraging providers to look to other treatment options while analysis continues.
‘Alarming’ Paclitaxel-Coated Device Findings Trigger UK Safety Probe
An expert advisory group set up by UK regulators has been given a few months to review the safety of paclitaxel-eluting balloons and stents in the treatment of patients with peripheral arterial disease, following a recent study that produced worrying results.