Consumers may not have been sufficiently warned about Pradaxa bleeding risks, with new data suggesting that uncontrollable, life-threatening bleeds may be common on the blood-thinning drug.

Pradaxa (dabigatran) is a blood thinner drug often prescribed to patients who have a high risk of dangerous clotting. The anticoagulant is designed and manufactured by Boehringer Ingelheim and was approved by the U.S. Food and Drug Administration (FDA) in 2010. Pradaxa is a modern blood thinner and, like many other modern blood thinners, competes directly with warfarin.

Warfarin has been the industry standard blood thinner for over 60 years and is widely trusted by both consumers and health professionals. Pradaxa is marketed competitively against warfarin by highlighting the drug’s positive qualities. For example, marketing often focuses on the infrequent blood monitoring and fewer dietary changes associated with Pradaxa.

These qualities put it ahead of warfarin, which requires regular blood monitoring and dietary changes. However, Pradaxa bleeding risks may make the blood thinning drug less safe than warfarin for some patients.

There are risks for bleeding events on any blood thinner, which is why warfarin requires such strict dosing and monitoring. However, Pradaxa bleeding risks may be far more dramatic than the typical risks associated with blood thinners.

In the first three months on the market, Pradaxa was involved with 307 reports to the FDA of uncontrollable bleeding. Within the first year, that number jumped to 260 reports of bleeding events involving a death. Due to the high number of adverse bleeding events associated with the drug, the FDA released a safety alert informing consumers about Pradaxa bleeding risks.

Consumers have reported a variety of complications associated with Pradaxa bleeding risks including internal bleeding, kidney bleeding, gastrointestinal bleeding, heart attack, stroke, brain hemorrhage, and death. Symptoms of a bleeding event will depend on the location and severity of a bleed. However, patients should consider Pradaxa bleeding risks and contact a medical professional about any signs of irregular bleeding.

In October 2015, Pradaxa became the first modern blood thinner to have an FDA-approved antidote when Praxbind was released. Preliminary approval was granted at an accelerated rate due to the historic nature of the drug, with full approval granted in April 2018. The drug has been sparsely available since initial approval but should become more widely available following full approval by the FDA.

Before Praxbind was approved, Pradaxa bleeding events had to be managed through dialysis and blood transfusions, both of which are difficult on the body and were not always effective. Although Praxbind stands to benefit countless consumers and save lives, the new drug does not help consumers who have already suffered due to Pradaxa bleeding risks.

These consumers may be eligible to take legal action against Boehringer Ingelheim for injuries caused by Pradaxa bleeding risks. Plaintiffs in a Pradaxa lawsuit often claim that the manufacturer failed to properly warn their consumers about Pradaxa bleeding risks.

If you or a loved one were injured in relation to Pradaxa bleeding risks, you may be eligible to file a lawsuit to recover compensation. A Pradaxa lawsuit could help recover compensation for medical expenses, pain and suffering, wrongful death, and more.