FDA has approved Eliquis to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation
The FDA ( Food and Drug Administration ) has approved the anti-clotting drug Eliquis ( Apixaban ), an oral tablet used to reduce the risk of stroke and dangerous blood clots ( systemic embolism ) in patients with atrial fibrillation that is not caused by a heart valve problem.
Atrial fibrillation, one of the most common types of abnormal heart rhythm, is an abnormal, irregular, and rapid beating of the heart in which the atria do not contract properly, allowing blood clots to form in them. These clots can break off and travel to the brain or other parts of the body.
The safety and efficacy of Eliquis in treating patients with atrial fibrillation not caused by cardiac valve disease were studied in a clinical trial of more than 18,000 patients that compared Eliquis with the anti-clotting drug Warfarin ( Coumadin ).
In the trial, patients taking Eliquis had fewer strokes than those who took Warfarin.
Patients with prosthetic heart valves should not take Eliquis nor should patients with atrial fibrillation that is caused by a heart valve problem. These patients were not studied in clinical trial.
As with other FDA-approved anti-clotting drugs, bleeding, including life-threatening and fatal bleeding, is the most serious risk with Eliquis. There is no agent that can reverse the anti-coagulant effect of Eliquis.
Eliquis will be dispensed with a patient Medication Guide that provides instructions on its use and drug safety information. Health care professionals should counsel patients on signs and symptoms of possible bleeding. ( Xagena )
Source: FDA, 2012