FDA panel again rejects wider use of J&J's Xarelto

A panel of Food and Drug Administration experts again opposed expanding use of Johnson & Johnson's blood thinner Xarelto to reduce dangerous blood clots in a new group of patients, those with acute coronary artery disease.

The FDA panel on Thursday voted unanimously against broader use of the pill, saying too much information is missing from company studies to accurately gauge Xarelto's benefit. The same panel also voted against broader approval in 2012.

The FDA, which is not required to follow the panel's advice, has also twice rejected J&J's request to approve Xarelto for preventing life-threatening blood clots in patients with acute .

J&J already markets the pill for several patient groups, including those with an irregular heartbeat and those undergoing hip or knee replacement surgery.

Related Stories

FDA advisers unanimously back J&J hepatitis C drug

date Oct 24, 2013

An experimental hepatitis C drug from Johnson & Johnson has won unanimous support from government experts who say the medication should be approved to treat patients infected with the liver-destroying virus.

Xarelto's approval expanded

date Nov 05, 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.

Bayer drug unproven as stroke preventer: US

date Sep 06, 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.

Recommended for you

FDA clears drug for leading form of cystic fibrosis

date Jul 02, 2015

Federal health officials have approved a new combination drug for the most common form of cystic fibrosis, the debilitating inherited disease that causes internal mucus buildup, lung infections and early death. But it will ...

User 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.