The FDA said Eliquis, or apixaban, can be given orally in tablet form to patients with atrial fibrillation, an abnormal, irregular and rapid beating of the heart in which the heart's two upper chambers do not contract properly and allow blood clots to form in them. These clots can break off and travel to the brain or other parts of the body, causing a stroke or heart attack.
"Blood clots in the heart can cause a disabling stroke if the clots travel to the brain," Dr. Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "Anti-clotting drugs lower the risk of having a stroke by helping to prevent blood clots from forming."
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. 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, the FDA said.
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.
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