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

Amgen announces Repatha® (evolocumab) significantl…

Amgen (NASDAQ:AMGN) has announced that the FOURIER trial evaluating whether Repatha® (evolocumab) reduces the risk of cardiovascular events in patients with clinically ev...

Read more

Vitamin D discovery could prove key to new treatme…

A team led by Motonari Uesugi, professor and deputy director of Kyoto University's Institute for Integrated Cell-Material Sciences (iCeMS), found that a vitamin D metabol...

Read more

Nuts can inhibit the growth of cancer cells

Roasted and salted, ground as a baking ingredient or fresh from the shell - for all those who enjoy eating nuts, there is good news from nutritionists at Friedrich Schill...

Read more

The drugs don't work, say back pain researchers

Commonly used non-steroidal anti-inflammatory drugs, such as ibuprofen, used to treat back pain provide little benefit, but cause side effects, according to new research ...

Read more

An alternative theory on how aspirin may thwart ca…

Studies abound that point to a role for plain old aspirin in keeping deadly cancers at bay. While aspirin is not yet part of mainstream treatment for any cancer, it is re...

Read more

Novo Nordisk enters collaboration with University …

University of Oxford and Novo Nordisk today announced a landmark research collaboration focused on type 2 diabetes. The partnership will enable scientists from Novo Nordi...

Read more

Relationship expert teams up with Pfizer to addres…

Nationally-recognized relationship expert and author, Logan Levkoff, Ph.D., has partnered with Pfizer Inc. (NYSE:PFE) to fill a void in information available to people li...

Read more

Pfizer reports fourth-quarter and full-year 2016 r…

Pfizer Inc. (NYSE: PFE) reported financial results for fourth-quarter and full-year 2016 and provided 2017 financial guidance. Pfizer manages its commercial operations th...

Read more

Anti-inflammatory diet could reduce risk of bone l…

Anti-inflammatory diets - which tend to be high in vegetables, fruits, fish and whole grains - could boost bone health and prevent fractures in some women, a new study su...

Read more

Sex, drugs, and rock and roll chemistry in the bra…

The same brain-chemical system that mediates feelings of pleasure from sex, recreational drugs, and food is also critical to experiencing musical pleasure, according to a...

Read more

Drug shows promise for treating alcoholism

UCLA researchers have found that an anti-inflammatory drug primarily used in Japan to treat asthma could help people overcome alcoholism. Their study is the first to eval...

Read more

Novartis delivered solid 2016 performance

Novartis announced today that the net sales were USD 48.5 billion (-2%, 0% cc) in the full year, as volume growth of 6 percentage points was offset by the negative impact...

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 ]