Bayer drug unproven as stroke preventer: US

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.

"There is a lack of substantial evidence that rivaroxaban will have its desired effect when used as recommended in labeling," said documents released by the US Food and Drug Administration.

An advisory committee to the FDA would further discuss the latest findings on Thursday.

"This review posted today has to do with the application for the new use and at this point does not impact the already-approved use," said FDA spokeswoman Sandy Walsh.

Xarelto is currently on the market to reduce the risk of blood clots, , and following knee or .

Bayer's stock plunged nearly 12 percent by midday in US trading.

Related Stories

J&J wins US approval for new blood thinner

date Jul 02, 2011

(AP) -- Johnson & Johnson said Friday that U.S. regulators have approved its new type of blood thinner shown to reduce deadly blood clots in patients who have undergone knee and hip replacements.

New warning OK'd for birth control patch

date Jan 21, 2008

The U.S. Food and Drug Administration has approved a warning for the Ortho Evra Contraceptive Transdermal Patch label concerning the risk of blood clots.

New no-needle approach to prevent blood clots

date Aug 11, 2009

The dean of the University of Oklahoma College of Public Health and a team of scientists worldwide have found a better way to prevent deadly blood clots after joint replacement surgery - a major problem that ...

Recommended for you

US appeals court upholds delay in Alzheimer's drug swap

date May 22, 2015

A federal appeals court has rejected a drug manufacturer's appeal and affirmed a judge's order that Actavis PLC keep distributing its widely used Alzheimer's medication until after its patent expires this summer.

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.