The Food and Drug Administration Friday approved a stroke-prevention medicine that will compete in that category against the blood-thinner warfarin, which is sometimes sold under the name Coumadin.
The FDA issued a news release saying that it had given the go-ahead to the anti-clotting drug Eliquis, or apixaban, an oral tablet developed by Pfizer Inc. and Bristol-Myers Squibb Co.
Eliquis can be used to treat what USA Today called the most common kind of irregular heartbeat, atrial fibrillation, in patients at risk for blood clots and strokes.
Atrial fibrillation is an abnormal, irregular, and rapid beating of the heart in where the heart’s two upper chambers (atria) do not contract properly, allowing blood clots to form in them, the FDA said in its press release, adding that these clots can break off and travel to the brain or other parts of the body.
“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 success 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,” 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, the FDA warned.
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.
According to USA Today, in recent years the FDA approved two other anti-clotting drugs for atrial fibrillation, Pradaxa and Xarelto. They, along with Eliquis, will compete for market share against warfarin, which USA Today said “requires frequent blood tests” to be sure the dosage is enough to prevent strokes but not high enough to cause internal bleeding.