Xarelto's approval expanded

November 5, 2012

(HealthDay)—Approval of the anti-clotting drug Xarelto (rivaroxaban) has been expanded by the U.S. Food and Drug Administration to include treating deep vein thrombosis (DVT) or pulmonary embolism.

DVT occurs when a blood clot forms in a vein deep in the body. If a clot breaks away and travels to an artery in the lungs, it becomes a potentially deadly condition called a pulmonary embolism.

Xarelto was approved last year to treat clots stemming from knee or hip replacement and to lessen the risk of stroke in people with a form of called non-valvular atrial fibrillation.

The drug's newest approvals were given based on clinical studies involving 9,478 people, the FDA said in a news release. As with other anti-clotting drugs, bleeding is the most common side effect.

Xarelto is produced by Janssen Pharmaceuticals, based in Raritan, N.J.

Explore further: Bayer drug unproven as stroke preventer: US

More information: The FDA has more about this approval.

Related Stories

Bayer drug unproven as stroke preventer: US

September 6, 2011

US regulators said Tuesday that Xarelto, a Bayer-made drug approved in July for preventing blood clots, is so far unproven for a new proposed use as a stroke preventer.

J&J again seeks more approvals for clot blocker

September 7, 2012

(AP)—Johnson & Johnson has given the Food and Drug Administration additional data to on its new anticlotting drug, in a second attempt to get approval for more uses.

Recommended for you

Why kicking the opioid habit can be so tough

July 20, 2016

(HealthDay)—He was 26, a specialist fifth class with the U.S. Army, and stationed abroad, when an accident on the German autobahn sent him careening through the windshield of his car.

New research shows vaccine protection against Zika virus

June 28, 2016

The rapid development of a safe and effective vaccine to prevent the Zika virus (ZIKV) is a global priority, as infection in pregnant women has been shown to lead to fetal microcephaly and other major birth defects. The World ...

Can exercise be replaced with a pill?

October 2, 2015

Everyone knows that exercise improves health, and ongoing research continues to uncover increasingly detailed information on its benefits for metabolism, circulation, and improved functioning of organs such as the heart, ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.