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

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 Rejects New Blood Thinner -- for Now

Brilinta Beat Plavix in International Trial, but Not in U.S./Canada Patients
WebMD Health News
Reviewed by Louise Chang, MD

Dec. 17, 2010 -- The FDA has rejected Brilinta, AstraZeneca's new blood thinner, because U.S. and Canadian patients did not benefit from the drug in a pivotal clinical trial.

Overall, the multinational study found that Brilinta worked better than Plavix, the current gold-standard drug to prevent blood clots in patients who receive stents for blocked coronary arteries.

But exactly why North American patients enrolled in the study did not benefit from Brilinta treatment remains a mystery.

That appears to be why the FDA yesterday refused to approve Brilinta, overruling last July's 7-1 vote for approval by an expert advisory panel.

The silver lining for AstraZeneca is that the FDA is not calling for a new clinical trial -- only for a new analysis of the study data.

During the panel meeting, the experts looked at several differences between North American and European study participants. The U.S. and Canadian patients took higher doses of aspirin, but the experts were left scratching their heads over how this might affect how Brilinta worked.

One hint is the U.S. and Canadian patients were less likely to take their medications exactly as prescribed. Brilinta wears off more quickly than Plavix -- which can be an advantage if further surgery is needed -- but that means missing just one of the drug's twice-daily doses could be dangerous.

Analysts predict that the FDA eventually will approve Brilinta, but that this won't happen before 2012.

Brilinta is approved in Europe, where it will be sold under the brand name Brilique.

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