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Outpatient Surgery E-Weekly

OR Excellence Pre-Registration Ends Wednesday

This Wednesday, Sept. 1, is your last chance to participate in Outpatient Surgery Magazine's OR Excellence 2010 Pre-Registration Contest. There's no...

Researchers Predict Anesthesiologist Shortage, CRNA Surplus

A recent analysis of the anesthesia labor market speculates that a current shortfall of providers across the surgical industry could widen in the ne...

A Change of Mind: Anesthesia, Consciousness and the Brain

The brain works through different processes as it transitions between conscious and unconscious states, a finding that bucks commonly held assumptio...

Home > News > March, 2009

FDA Panel Recommends Drug to Prevent DVT

If approved, rivaroxaban would be marketed for use in patients undergoing hip and knee replacements.

A Food and Drug Administration advisory committee has recommended that the agency approve a new drug to prevent deep vein thrombosis and pulmonary embolism in patients after hip- or knee-replacement surgery.

If approved, rivaroxaban, a joint venture between Bayer Healthcare Pharmaceuticals and Johnson & Johnson, would be the first major competitor to warfarin, which has been the dominant oral anticoagulant to treat thrombosis on the market. Johnson & Johnson is initially only seeking approval to market rivaroxaban for short-term use after orthopedic surgery, but industry analysts say the medication’s applications may expand in the future.

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 15-2 to recommend approval of the drug. The New York Times reports that the agency typically goes with the recommendations of its advisory panels, but notes that "the review of rivaroxaban was not without contention." Twenty-four patients who took rivaroxaban pills in the clinical trials experienced major bleeding, compared with 13 who had injections of a different anticoagulant drug, enoxaparin.

Irene Tsikitas

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