FDA to require enhanced warnings on labels of certain drug-coated medical devices

The U.S. Food and Drug Administration will allow medical devices for the legs coated with the drug paclitaxel to remain on the market, but with increased scrutiny and enhanced patient warnings after the discovery that the devices are associated with long-term higher risks of death.

An updated letter to doctors posted by the FDA on Wednesday says the agency is "working with" devicemakers to include warnings on product labels explaining what's known about the risk. While the agency will continue allowing commercial sales of the devices, patients treated in clinical trials will receive enhanced informed consent disclosures and will be subject to closer ongoing scrutiny by safety-monitoring boards.

http://www.startribune.com/fda-to-require-enhanced-warnings-on-labels-of-certain-drug-coated-medical-devices/525822001/