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FDA OKs stronger paclitaxel warnings

Aug 08, 2019 - Star Tribune (Minneapolis, Minnesota)

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 cont...