The U.S. Food and Drug Administration approved the anti-clotting drug Eliquis (apixaban), a verbal tablet used to reduce the risk of stroke and dangerous thrombus (systemic embolism) in patients with atrial fibrillation that’s not caused by a cardiac valve problem.
Atrial fibrillation, probably the most common kinds of abnormal heart rhythm, is surely an abnormal, irregular, and rapid beating on the heart when the heart’s two upper chambers (atria) will not contract properly, allowing blood clots in order to create in the individual. These clots can back out of and visit as their pharmicudical counterpart or other regions with the body.
“Thrombus from the heart might cause a disabling stroke if your clots happen to be mental performance,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products from the FDA’s Center for Drug Evaluation and Research. “Anti-clotting drugs lower risking potential using a stroke by helping to prevent thrombus from forming.”
The safety and efficacy of Eliquis in treating patients with atrial fibrillation not caused by cardiac valve disease were studied inside a clinical test of greater than 18,000 patients that compared Eliquis with the anti-clotting drug warfarin. Inside the trial, patients taking Eliquis had fewer strokes compared to those who took warfarin.
Patients with prosthetic heart valves must not take Eliquis nor should patients with atrial fibrillation that is the result of a cardiac valve problem. These patients were not studied in medical trial. Just like other FDA-approved anti-clotting drugs, bleeding, including life-threatening and fatal bleeding, is one of serious risk with Eliquis. There isn’t a agent that can reverse the anti-coagulant effect of Eliquis.
Eliquis will probably be dispensed having a patient Medication Guide that provides instructions on its use and drug safety information. Health care professionals should counsel patients on warning signs of possible bleeding.
Eliquis is manufactured Bristol-Myers Squibb Company of Princeton, N.J. and marketed by BMS and Pfizer Inc. of New York.
Source: FDA News Release
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