Study: New Blood Thinners Associated with GI Bleed Risk

Another study revealed issues related to new anti-coagulants, such as Pradaxa, including serious bleeds.

The new study revealed that, based on a pooled analysis of 17 randomized controlled trials (RCTs) there was an increased risk of stomach bleeding in patients who received newer anti-coagulant medications when compared to people on traditional care, according to I. Lisanne Holster, MD, of Erasmus MC University Medical Centre in Rotterdam, the Netherlands, and colleagues, wrote MedPage Today. One sub-group analysis revealed that drugs such as Pradaxa (dabigatran etexilate mesylate) were associated with increased risks for gastrointestinal (GI) bleeds when compared to traditional treatment, such as warfarin.

For about 50 years, warfarin—also known by the brand name, Coumadin—was prescribed to patients diagnosed with atrial fibrillation (AF), an irregularity of the heartbeat, and others at risk of forming potentially fatal blood clots. Warfarin is an anticoagulant medication. Pradaxa is a blood-thinning medication used to reduce risks of stroke and blood clots in patients with non-valvular AF, a common heart rhythm abnormality; Pradaxa is not approved for patients with AF caused by heart valve problems. Pradaxa also inhibits thrombin, which is, explained News-Medical, the central coagulation activator in the body’s blood clotting system.

Both Pradaxa and warfarin can cause internal bleeding, but there are readily available antidotes for warfarin bleeding. A growing number of Pradaxa bleeding lawsuits allege the drug caused serious, uncontrollable bleeding side effects, including GI bleeding and cerebral hemorrhaging for which there is no reversal agent.

Other research has revealed that Pradaxa should not be used to prevent stroke or blood clots in patients implanted with mechanical heart valves, and the U.S. Food and Drug Administration (FDA) informed health care professionals and the public of the dangers of Pradaxa for patients with mechanical heart valves. A clinical trial in Europe was halted because Pradaxa users were likelier to experience strokes, heart attacks, and blood clots forming on the heart devices than were users of warfarin. Pradaxa users also experienced more bleeding after valve surgery than those taking warfarin.

Despite a growing number of serious GI bleed reports linked to Pradaxa, the FDA argues that the blood thinner, manufactured by Behringer Ingelheim, is safe when used as directed. Pradaxa, approved more than two years ago, has been associated with a large number of post-marketing incidences of GI bleeding; however, the FDA states that it has concluded that Pradaxa bleeding rates are no higher that what is reported in patients taking warfarin, a decades-old and traditional blood thinner treatment. Yet, Pradaxa has been linked to over 500 deaths and even more side effect reports than any other drug, noted Forbes previously, citing the Institute for Safe Medicine Practices (ISMP). One major problem with Pradaxa–unlike warfarin—is that there is no antidote for a Pradaxa bleed.

A new study also found that Pradaxa may increase risks for viral infections, as well as increasing the severity of these infections.

Meanwhile, the editorialists associated with this study expressed concern over the lack of antidotes for these new blood thinners. “This is an alarming fact given the widespread use of new oral anticoagulants and the increased risk of bleeding that has now been demonstrated,” the researchers said, according to MedPage Today. The team urged for clear, concise guidelines for managing acute GI bleeds in patients taking these new drugs noting that while the rate for such bleeds may be low, the bleeds were significant and serious.