Xarelto May Prevent Strokes, But Could Carry Bleeding Problems Like Pradaxa

A new study has found that the anti-clotting drug Xarelto could carry less of a risk of causing a stroke than older blood thinners, but the drug appears to carry some of the same risks plaguing a new generation of anticoagulants, such as Pradaxa. 

The study, which was funded by Johnson & Johnson, the manufacturers of the new medication Xarelto, was presented last week at the American Stroke Association’s International Stroke Conference in New Orleans.

According to researchers from Australia, users of Xarelto were one-third less likely to experience brain bleeding than patients given warfarin, an older blood thinner also known as Coumadin, when the drug was prescribed for the treatment of atrial fibrillation. However, Xarelto, like its pharmaceutical cousin, Pradaxa, belongs to a new wave of blood thinners that require less monitoring, but may cause severe bleeding problems that are more difficult to treat.

Pradaxa (dabigatran) is a blood thinner that was just introduced in October 2010, as an alternative to warfarin for prevention of strokes among individuals with atrial fibrillation. The medication has been heavily promoted by the manufacturer, Boehringer Ingelheim, and it quickly grew to be widely used.

Xarelto, Pradaxa and other newer anticoagulents are designed to be easier to use, since they do not require the monitoring associated with warfarin use. However, if severe bleeding problems do occur with warfarin, they can be treated by an infusion of Vitamin K, and there is no easy fix for bleeding problems with Pradaxa, and similar medications like Xarelto.

In December, the FDA announced that it was launching a safety investigation into reports of severe bleeding events with Pradaxa, after a surprising number of deaths and severe injuries were submitted to the agency’s adverse event reporting system during the first year Pradaxa was on the market.

There has been growing alarm among experts about the safety of the drug, and some researchers have recently questioned the validity of the drug’s pre-approval clinical trials, saying that they were so flawed that the FDA should have never approved Pradaxa for the market.

The Institute of Safe Medication Practices (ISMP) reported that the FDA received hundreds of complaints about Pradaxa problems just weeks after it was released, mostly related to bleeding events in elderly patients.

A growing number of individuals throughout the United States are now considering a potential Pradaxa lawsuit against Boehringer Ingelheim after suffering problems like internal bleeding, hemorrhages, heart attacks, strokes and sudden death.