FDA advisers, staff split on blood thinner

WASHINGTON, D.C.; September 8, 2011

That's because the agency's staff and advisers are at loggerheads over a new drug.

Outside advisers to the FDA have voted to recommend that the agency approve a new anticlotting drug developed by Johnson & Johnson and partner Bayer Healthcare.

That's despite a very negative review by FDA staff of the drug, Xarelto, released two days ago.

Nine panel members voted to recommend approval, two voted against and one person abstained. The FDA is to make a final decision soon.

The recommendation, after a daylong hearing, is to allow sales of the drug for preventing strokes in patients with a common irregular heartbeat known as atrial fibrillation.

Xarelto, known chemically as rivaroxaban, has been seen as a future blockbuster drug.

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