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Pharmaceuticals / Regulatory Affairs

FDA Issues Warning Over Paclitaxel-Coated Balloons, Stents

March 26, 2019

The FDA issued an updated alert based on a “potentially concerning signal” that the chemotherapy drug paclitaxel on balloons and stents might be contributing to patient deaths.

The agency said the data “should be interpreted with caution,” but a provisional review of three clinical trials with at least five years of follow-up data found that peripheral arterial disease patients who received balloons or stents coated in paclitaxel were nearly 50 percent more likely to die than patients whose devices weren’t coated in paclitaxel.

The agency issued a notice following up on a Jan. 17 alert, after a meta-analysis published in the Journal of the American Heart Association warned that patients receiving the coated balloons or stents were not doing well.

Most commonly sold under the brand name Taxol, paclitaxel is used in the treatment of breast, lung and ovarian cancer, as well as Kaposi's sarcoma. Now owned by Brystol-Myers Squibb, it had been the world’s top-selling cancer drug in the late 1990s and early 2000s. The drug is used in combination products such as drug-coated balloons and stents because it has been shown to improve blood flow.

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