Despite Bleeding Risks with Xarelto, Pradaxa, Greater Use of Drugs Pushed

Amid continuing concerns about the risk of uncontrollable bleeding associated with side effects of Xarelto and Pradaxa, a British health agency is calling for an increase in use of the medications, which are part of a new class of anticoagulants. 

The U.K.s National Institute for Health and Care Excellence (NICE) released new guidance this week on the use of blood thinners for patients with atrial fibrillation, indicating that doubling the number of people on the new drugs could prevent thousands of strokes and deaths each year. NICE suggests that only about 45% of patients that should be taking the controversial drugs are actually prescribed them.

The guidance comes among ever-increasing reports of uncontrollable bleeding problems with Xarelto and Pradaxa, which doctors typically have a difficult time treating due to the lack of an approved reversal agent.

Pradaxa and Xarelto have been introduced in recent years as a superior replacement for warfarin, which has been on the market for decades. While the drugs are easier to use and require less monitoring, concerns have emerged about the risk of severe and life-threatening bleeding problems that may be caused by the lack of an available antidote, unlike warfarin.

Within the few years since the drugs were introduced in the United States, they have quickly grown to become among the most commonly cited medications in adverse event reports submitted to the FDA.

NICE acknowledges there is a bleeding event risk with Xarelto and Pradaxa, but says that the potential benefits outweigh the risks. In a new patient guide (PDF), there is a chart to help each individual patient compare the blood thinners and their relative risks of bleeding on each one. That can be affected by kidney function, age and other factors.

Atrial fibrillation is a condition that causes irregular heartbeat, and can lead to strokes and death. Treatment of AF is often through the use of blood thinners like warfarin, also sold under the brand name Coumadin, which was first approved in 1956. However, warfarin requires extensive monitoring and dose adjustments.

Pradaxa and Xarelto Bleeding Risks

Pradaxa was the first member of this new generation of blood thinners, approved in the United States in October 2010. Xarelto was introduced in late 2011, and has grown to become the most widely used medication in the class.

Unlike warfarin, the effects of which can quickly be reversed with a dose of vitamin K, there is no approved antidote to address Pradaxa and Xarelto bleeding events. Reports suggest that this may lead to more severe outcomes, including a risk of death.

According to a report released by the Institute for Safe Medication Practices (ISMP) earlier this year, there were at least 680 serious adverse event reports linked to Xarelto, with another 528 associated with Pradaxa.

A number of Xarelto lawsuits and Pradaxa lawsuits are being pursued in the U.S., alleging that the drug makers failed to provide adequate warnings about the risk of uncontrollable bleeding and the lack of an available reversal agent.

Boehringer Ingelheim recently agreed to pay about $650 million to settle Pradaxa cases filed by about 4,000 people nationwide.