Treatments for Peripheral Arterial Disease Linked with Increased Risk of Death

By Burg Simpson

Peripheral Arterial Disease

January 18, 2019   Ohio Dangerous Drugs and Medical Devices, Ohio Legal Updates

Treatments for Peripheral Arterial Disease Linked with Increased Risk of Death

By Jessica Powell, Burg Simpson Associate

The FDA recently released a letter warning physicians about a new study linking two treatments for peripheral arterial disease– paclitaxel-coated balloons and paclitaxel-coated stents– with an increased risk of death when compared to non-coated balloons or stents. In the study, researchers found a significantly increased risk of death in patients with paclitaxel exposure two years after the balloon/ stenting procedure. An increased risk of death was also noted at 5 years after the procedure. Overall, the study found “a significant relationship between exposure to paclitaxel … and absolute risk of death.”

The FDA is currently reviewing its data to determine whether there are any long-term risks associated with paclitaxel coated products. At this time, however, “the FDA believes that the benefits continue to outweigh the risks” of this product and advises physicians to report any adverse events to the FDA

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