FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation

The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration 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 heart's two upper chambers (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.

"Blood clots in the heart can cause a disabling stroke if the clots travel to the brain," said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in 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."

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. 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.

Eliquis is manufactured Bristol-Myers Squibb Company of Princeton, N.J. and marketed by BMS and Pfizer Inc. of New York.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Most Popular Now

Sanofi and Regeneron announce FDA Approval of Kevz…

Sanofi and Regeneron Pharmaceuticals, Inc. have announced the U.S. Food and Drug Administration (FDA) approval of Kevzara® (sarilumab) for the treatment of adult patients...

Read more

FDA approves first cancer treatment for any solid …

The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is th...

Read more

FDA approves drug to treat ALS

The U.S. Food and Drug Administration today approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig's...

Read more

AstraZeneca marks a key milestone with the ‘toppin…

AstraZeneca marks a key milestone in its successful move to Cambridge, UK, with the 'topping out' of its new, state-of-the-art, strategic R&D centre and global corporate ...

Read more

Abbott announces CE Mark and first use of the worl…

Abbott (NYSE: ABT) today announced CE Mark and first use of the new Confirm RxTM Insertable Cardiac Monitor (ICM), the world's first smartphone compatible ICM that will h...

Read more

Imfinzi significantly reduces the risk of disease …

AstraZeneca and MedImmune, its global biologics research and development arm, today announced positive results for the Phase III PACIFIC trial, a randomised, double-blind...

Read more

Antibiotic doxycycline may offer hope for treatmen…

A study published in the journal Scientific Reports suggests that doxycycline, an antibiotic used for over half a century against bacterial infections, can be prescribed ...

Read more

Novartis exercises exclusive option agreement with…

Novartis announced today that it has notified Conatus Pharmaceuticals Inc., of its exercise of the option to an exclusive license for the global development and commercia...

Read more

High levels of exercise linked to nine years of le…

Despite their best efforts, no scientist has ever come close to stopping humans from aging. Even anti-aging creams can't stop Old Father Time. But new research from Brigh...

Read more

Vitamin A deficiency is detrimental to blood stem …

Many specialized cells, such as in the skin, gut or blood, have a lifespan of only a few days. Therefore, steady replenishment of these cells is indispensable. They arise...

Read more

Nearly 1 in 3 drugs found to have safety concerns …

How often are safety concerns raised about a drug after it's been approved by the FDA? Nicholas Downing, MD, of the Department of Medicine at Brigham and Women's Hospital...

Read more

Alzheimer's experts call for changes in FDA drug a…

Leading Alzheimer's disease researchers and a prominent patient advocate today published an analysis, "Single Endpoint for New Drug Approvals for Alzheimer's Disease," ur...

Read more

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]