FDA grants approval for Eliquis to prevent Strokes in Atrial Fibrillation Patients

Medication bottle - BSN

(Best Syndication News) - The U.S. Food and Drug Administration (FDA) granted approval of Eliquis (apixaban) tablets for people who have atrial fibrillation that is not related to a heart-valve problem. The medication would be used as a way to reduce the risk of stroke by preventing blood clots from forming.

Atrial fibrillation causes the heart to beat irregularly and rapidly. The two upper chambers of the heart do not squeeze correctly to insure proper blood flow. This inadequate pumping can cause blood clots to form. The risk of a stroke occurs when the blood clot breaks free and prevents blood flow to parts of the brain. Additionally, the blood clot could break free and travel to other parts of the body, such as the lungs or legs.

Eliquis is an anti-clotting drug that would help prevent the risk of a stroke in these patients.

To gain FDA approval, a clinical trial of over 18,000 patients with atrial fibrillation - not caused by cardiac valve disease - was conducted. Eliquis was tested and compared against the blood-thinner warfarin. The study found those patients taking Eliquis had fewer strokes than the warfarin group.

Eliquis was not studied with atrial fibrillation patients who have prosthetic heart valves, and therefore they should not take medication.

Life-threatening and fatal bleeding can occur from taking Eliquis, however, this is a similar risk seen with other FDA-approved anti-clotting medications. No agent is available for Eliquis that would reverse the anti-coagulant effect. Because of the risks, patients should be counseled on what to look for if they are bleeding. Additionally, a patient medication guide will also provide instructions on safety and use of Eliquis.

Bristol-Myers Squibb Company of Princeton, N.J. is the manufacturer of Eliquis. BMS and Pfizer Inc. of New York will market the drug.

By: Marsha Quinn
Health Reporter

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