FDA Approves Novel Anticoagulant Savaysa

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FDA Approves Novel Anticoagulant Savaysa
FDA Approves Novel Anticoagulant Savaysa

(HealthDay News) -- Savaysa (edoxaban) has been approved by the U.S. Food and Drug Administration to reduce the risk of stroke and systemic embolism, and prevent deep vein thrombosis and pulmonary embolism.

The drug was approved for people with atrial fibrillation that isn't caused by a heart valve problem, and for people with deep vein thrombosis or pulmonary embolism, the FDA said in a news release.

Clinical studies compared Savaysa to warfarin. The newly-approved drug was found as effective as warfarin in preventing stroke, but had significantly fewer cases of major bleeding episodes that can affect warfarin patients, the FDA said.

Nonetheless, bleeding was recorded as a primary side effect of Savaysa, as was anemia. Savaysa's label will include a boxed warning that the drug may be less effective among people with a creatinine clearance greater than 95 milliliters per minute. The advisory also warns that sudden discontinuation of Savaysa increases the risk of stroke.

Savaysa is made by the Japanese pharmaceutical company Daiichi Sankyo, based in Tokyo.

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