MHRA Advises of Serious Risks for Paclitaxel-Coated Devices

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has warned that paclitaxel drug-coated balloons or drug-eluting stents have mortality risks that generally outweigh their benefits for routinely treating patients with widening of the arteries.

However, using the devices in patients with critical-limb ischemia remains an option in selected cases, where the benefits may outweigh the risks, the agency said.

Concerns about the use of paclitaxel-coated balloons surfaced following a December 2018 study that warned against treating patients with peripheral arterial disease, a build-up of deposits in the arteries that restrict blood supply to leg muscles.