From Our 2013 Archives
FDA Approves New Blood Thinner Eliquis
By Jennifer Warner
Reviewed by Brunilda Nazario, MD
AFib is the most common type of irregular heartbeat and affects about 3 million Americans.
People with AFib are about five times more likely to have a stroke.
Eliquis is approved only for use in people with AFib that is not caused by a heart valve problem. People with prosthetic heart valves should not take Eliquis.
In its approval, the FDA cited a clinical trial of Eliquis in more than 18,000 people with AFib.
The results showed that people who took Eliquis twice a day had 21% fewer strokes than those on the blood thinner warfarin.
AFib raises the risk of stroke because if the heart doesn't beat strongly and regularly, blood can pool in the heart and become more likely to form clots.
"Blood clots in the heart can cause a disabling stroke if the clots travel to the brain," says Norman Stockbridge, MD, PhD, of the FDA's Center for Drug Evaluation and Research. "Anti-clotting drugs lower the risk of having a stroke by helping to prevent blood clots from forming."
New Options in Stroke Prevention
Eliquis is now the third new blood thinner to be approved as an alternative to warfarin since 2010. Pradaxa, produced by Boehringer Ingelheim, was approved in 2010, and Xarelto, marketed by Johnson & Johnson and Bayer AG, was approved in 2011.
The approval of Bristol-Myers Squibb and Pfizer's Eliquis comes six months after the agency delayed its decision on the new blood-thinning drug.
Researchers say these new alternatives to warfarin are easier to take and are believed to be safer than warfarin, also known as Coumadin.
People taking warfarin must have their blood tested regularly because the drug can raise the risk of life-threatening bleeding.
Although researchers say people taking the new types of blood thinners do not have to be monitored as closely, the risk of life-threatening bleeding is still an issue.
There is no agent that can rapidly reverse the anti-clotting effect of Eliquis and the other new-generation blood thinners.
FDA says health care professionals should counsel people taking Eliquis and other blood thinners about the symptoms of possible bleeding, such as, paleness and fatigue.
SOURCES: News release, FDA. News release, Bristol-Myers Squibb. WebMD Medical News: "FDA Delays Decision on Blood Thinner Eliquis." Medical Reference from Healthwise, "Atrial Fibrillation - Overview."