FDA Panel Concludes that Warning Labels Should Inform Patients of Potential Long-Term Risk of Death Associated With Paclitaxel Devices
UNITED STATES – As reported online by www.medtechdive.com, an FDA panel recently concluded that manufacturers of paclitaxel devices should include a warning in the devices’ labels informing patients and doctors of a potential link between the devices and a long-term risk of death.
An FDA panel met to discuss the risks and benefits associated with paclitaxel devices, which include paclitaxel-coated balloons and paclitaxel-coated stents used to treat patients with peripheral arterial disease (PAD). Paclitaxel is a medication released from a balloon or stent during procedures to prevent the formation of scar tissue.
The FDA’s Circulatory System Devices Panel and Advisory Committee concluded that paclitaxel-coated devices have benefits that exceed the known risks. However, the panel agreed that further testing and studies are necessary to rule out potentially dangerous and fatal risks, but there was disagreement among panel members on how such testing and studies should be performed.
Overall, the FDA panel reveals that there is little data to conclude one way or another that the use and dose of paclitaxel used to coat balloons and stents is linked to a long-term increased risk of death. Because an increased risk of death is a possibility, the FDA panel believes that including a warning for doctors and patients communicating a potential link between Paclitaxel and a long-term increased risk of mortality is essential for patients to make an informed decision about using the product.
Currently, there are no reported links between paclitaxel and an increased risk of mortality long-term. However, communicating a potential link on warning labels will ensure doctors and patients are receiving all information known and available by medical device manufacturers and the FDA.
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