U.K. Health Advisors Recommend Expanded Xarelto Use, Despite Bleeding Risks

Drug regulators in the U.K. are recommending that Xarelto be given to heart attack victims, despite the FDA’s rejection of repeated requests for similar use in the U.S. and continuing concerns about the risk of uncontrollable bleeding due to the lack of an available antidote for the anticoagulant. 

The U.K.’s National Institute for Health and Care Excellence (NICE) issued a draft guidance on Wednesday, which calls for the use of Xarelto to prevent blood clots in people who have suffered a heart attack.

The group plans to finalize guidance next year that would grant approval in that country to give Xarelto to patients with acute coronary syndrome (ACS); an approval NICE’s counterparts in the United States’ FDA have rejected numerous times, citing potential health concerns with Xarelto.

NICE recommends that the drug be used along with Plavix and aspirin to prevent cardiovascular death due to repeat heart attacks.

“People who have a heart attack are at higher risk of having further events,” Professor Carole Longston, NICE Health Technology Evaluation Centre Director, said in a press release. “This can have a negative impact on the quality of life of the person and their family because of worries over their future health. Any additional treatments to reduce that risk are therefore to be welcomed.

NICE expects the draft guidance to be finalized next March, which would clear the way for the drug to be used and paid for by the U.K. health care system for heart attack prevention in heart attack patients.

However, the group expressed some concern about uncontrollable bleeding problems with Xarelto.

The guidance recommends that doctors make a careful assessment of each patient’s bleeding risk before prescribing the drug. The group also notes that doctors should have a discussion with the patient about the benefits and risks of Xarelto when used in combination with aspirin and Plavix, or aspirin alone so that they can make informed consent.

While the makers of Xarelto are nearing success in getting expanded approval for Xarelto in the U.K., the FDA has rejected three previous attempts to get Xarelto approved to treat ACS in the United States.

In August, in their latest attempt to win over U.S. health regulators, the manufacturers announced three new clinical trials to show that Xarelto is safe for ACS treatment.

Xarelto Bleeding Risks

Xarelto (rivaroxoaban) was introduced by Bayer and Johnson & Johnson’s Janssen Pharmaceuticals in 2011, as part of a new generation of anticoagulants promoted as a superior alternative to Coumadin (warfarin), which has been the go-to blood thinner for prevention of strokes among patients with atrial fibrillation for decades.

While all blood thinners carry a risk of bleeding problems, Xarelto and other members of this new generation of anticoagulants lack an approved antidote that doctors can use to reverse the effects of the drug. While doctors can quickly stop the blood thinning effects of warfarin, users of Xarelto have reported experiencing uncontrollable bleeding that physicians were unable to stop, often leading to severe injury or death.

As the popularity of Xarelto has increased over the past two years, a growing number of bleeding complications have been associated with this drug as well.

The recent attempts to expand approval for the medication seems to support some of the allegations contained in a growing number of Xarelto lawsuits filed on behalf of users who suffered severe bleeding injuries or even death. The complaints allege that the manufacturers placed their desire for profits before consumer safety by aggressively marketing the drug with inadequate warnings, while failing to fully explore all potential reversal agents that may make the medication safe.

Many plaintiffs also allege that the benefits provided by the medication do not justify the risks, indicating that the drug makers should issue a Xarelto recall until a reversal agent can be developed.