FDA Rejects New Use for Xarelto, Cites Bleeding Risks

The FDA cited the increased risk of severe bleeding as one of the reasons for rejecting an attempt by Bayer and Johnson & Johnson to expand the use of their blood thinner Xarelto for prevention of heart attacks and strokes among patients with existing heart problems. 

The two drug makers, who jointly make and distribute Xarelto, were seeking to expand approval of Xarelto for the treatment of patients with acute coronary syndrome (ACS), a blanket definition for patients with heart blockages. However, FDA reviewers were concerned about the risk of patients suffering uncontrolled bleeding due to Xarelto side effects.

This is at least the second time the FDA has rejected an attempt to expand Xarelto usage. Last June, the agency rejected an application after complaining that data was missing from 1,000 clinical trial participants who dropped out of the Xarelto trial.

Xarelto (rivaroxaban) is one of several new anticoagulants introduced in recent years as an alternative to Coumadin (warfarin), which are promoted as easier to take because they require less monitoring during treatment.  It is part of a class of new blood thinners known as direct thrombin inhibitors.

The first medication approved from this class in the United States was Pradaxa (dabigatran), which was introduced in October 2010.  However, shortly after Pradadxa was introduced, a number of doctors began reporting severe bleeding complications that they were unable to stop due to the lack of a reversal agent for the new class of medications.

While warfarin has an antidote, vitamin K, which can be given to patients who experience hemorrhages or bleeding problems, Pradaxa and Xarelto currently have no such reversal agent or quick fix available, leaving doctors helpless to stop bleeds that develop on the medication.

Hundreds of Pradaxa lawsuits have already been filed against Boehringer Ingelheim, alleging the drug maker provided inadequate warnings to consumers and the medical community about the lack of a reversal agent and the increased risk of severe and potentially fatal bleeding events compared to warfarin.

Bayer and Johnson & Johnson indicated earlier this year that they are working on the creation of an Xarelto reversal agent, but it will likely not be available until later this year. Such an antidote would allow doctors to quickly reverse the effects of Xarelto, and stop bleeding compications, providing a substantial competitive advantage for the medication.

With about 1.2 million patients hospitalized for ACS every year, the FDA approval of Xarleto for this new use would also provide a major boost for the drug’s sales.