Find Information About:

Drugs & Supplements

Get information and reviews on prescription drugs, over-the-counter medications, vitamins, and supplements. Search by name or medical condition.

Pill Identifier

Pill Identifier

Having trouble identifying your pills?

Enter the shape, color, or imprint of your prescription or OTC drug. Our pill identification tool will display pictures that you can compare to your pill.

Get Started
My Medicine

My Medicine

Save your medicine, check interactions, sign up for FDA alerts, create family profiles and more.

Get Started

WebMD Health Experts and Community

Talk to health experts and other people like you in WebMD's Communities. It's a safe forum where you can create or participate in support groups and discussions about health topics that interest you.

  • Second Opinion

    Second Opinion

    Read expert perspectives on popular health topics.

  • Community


    Connect with people like you, and get expert guidance on living a healthy life.

Got a health question? Get answers provided by leading organizations, doctors, and experts.

Get Answers

Sign up to receive WebMD's award-winning content delivered to your inbox.

Sign Up

Heart Disease Health Center

Font Size

FDA Delays Decision on Blood Thinner Eliquis

One of Three Warfarin Alternatives for Stroke Prevention
WebMD Health News
Reviewed by Louise Chang, MD

June 25, 2012 -- The FDA has once again delayed a decision on a new blood thinning drug that some are calling a game changer for the prevention of stroke in heart patients.

Drug makers Bristol-Myers Squibb and Pfizer are seeking approval to market the drug Eliquis for use in patients with atrial fibrillation, a heart condition that affects about 3 million Americans and is projected to affect 12 million by 2050.

People with the heart rhythm disorder have about a five-fold increase in stroke risk.

In a trial sponsored by the companies, patients who took the drug twice a day were 21% less likely to suffer strokes than patients who took the blood thinner warfarin, which has been a standard treatment for the prevention of blood clots for many decades.

Eliquis users also had 31% fewer major bleeding episodes and their risk of death was reduced by 11%.

In a statement released today, the companies confirmed that the FDA is not asking for new studies of the drug, which could delay a decision for years.

Instead, federal officials want more information "on data management and verification" from the pivotal trial.

New-Generation Stroke Drugs

Eliquis is one of three new blood thinners developed as alternatives to warfarin.

Pradaxa, marketed by global drug maker Boehringer Ingelheim, became the first of the new-generation drugs to be approved late in 2010, followed last summer by Xarelto, marketed by Johnson & Johnson and Bayer AG.

Last November, the FDA granted an expedited review for Eliquis, which suggested that it would rule quickly on its approval. But in March the agency postponed action on the request until late June.

The arrival of the three new drugs has been widely anticipated, because the drugs are easier to take and believed to be safer that warfarin, which is also known as Coumadin.

Patients on warfarin must have their blood tested frequently because the drug can increase their risk for potentially life-threatening bleeding. It also interacts with some other drugs and foods, such as dark, leafy greens.

Today on WebMD

x-ray of human heart
A visual guide.
atrial fibrillation
Symptoms and causes.
heart rate graph
10 things to never do.
heart rate
Get the facts.
empty football helmet
red wine
eating blueberries
Simple Steps to Lower Cholesterol
Inside A Heart Attack
Omega 3 Sources
Salt Shockers
lowering blood pressure