Study Finds Pradaxa® Bleeding Risks Increase With Certain Statins

Pradaxa (dabigatran etexilate mesylate), a widely-prescribed anticoagulant medication manufactured by German pharmaceutical company Boehringer Ingelheim. It's used to prevent dangerous blood clots and strokes in patients with atrial fibrillation, a heart condition characterized by a rapid and irregular heartbeat. Despite its popularity and proven efficacy, Pradaxa is linked to uncontrollable bleeding that has resulted in hospitalizations and deaths, and sparked thousands of lawsuits.

While the bleeding risks associated with Pradaxa are now well known, many doctors and patients decided to stick with the drug, as it offers greater freedom and convenience compared to older anticoagulants. For example, unlike warfarin, Pradaxa offers one-size-fits-all dosing, doesn't have dietary restrictions, and doesn't require a patient to submit to regular blood tests to ensure it's working properly.

However, a November 2016 study found that Pradaxa's bleeding risk increased when the drug was used in conjunction with certain statins, raising new questions and concerns for doctors and patients alike.

St. Michael's Hospital Study

Researchers at St. Michael’s Hospital in Toronto conducted a study, the results of which they published in the November 21, 2016 issue of the Canadian Medical Association Journal.

The study—Association between statin use and ischemic stroke or major hemorrhage in patients taking dabigatran for atrial fibrillation— analyzed medical data from 46,000 patients 65 and older taking Pradaxa to reduce their risk of  atrial fibrillation-related stroke. Part of the data analysis included tracking the occurrence of major hemorrhages and ischemic strokes, caused by an obstruction in a blood vessel that supplies the brain.

The researchers uncovered disturbing findings. Patients who took Pradaxa with cholesterol control medications Mevacor® (lovastatin) and Zocor® (simvastatin) had a 40 percent higher risk of major hemorrhage compared to patients on other statins. Not surprisingly, the increase in bleeding risk also came with an increase in hospitalizations and emergency room visits.

So why does combining these drugs result in such potentially catastrophic consequences? Researchers believe it's because both Mevacor and Zocor inhibit a protein that limits Pradaxa absorption, increasing the amount of the drug in the bloodstream and amplifying its anticoagulant effects.

To avoid an increased risk of bleeding injury, patients taking Pradaxa along with Mevacor and Zocor should talk to their doctors about alternative treatments for lowering their LDL cholesterol. According to the researchers, other prescription statin medications don't have the same protein-blocking effects that increase Pradaxa absorption.

Pradaxa Bleeding Lawsuits

Thousands of former Pradaxa patients and their families filed lawsuits against Boehringer Ingelheim for allegedly failing to sufficiently warn them of the drug's bleeding risks. For many patients, these bleeding events were made even more troublesome—and sometimes fatal—because there wasn't a U.S. Food and Drug Administration (FDA) approved antidote to Pradaxa for the first five years it was on the market. The FDA approved Pradaxa in October 2010 and fast-tracked approval for its antidote, Praxbind®, in October 2015.

Due to the large number of Pradaxa bleeding lawsuits pending against Boehringer Ingelheim, the litigation was consolidated into multidistrict legislation and will be heard in United States District Court for the Southern District of Illinois by Judge David R. Herndon.

Did You Experience Serious Pradaxa Side Effects?

Any anticoagulant medication—whether it's a new generation drug like Pradaxa or a traditional blood-thinner like warfarin—carries the risk of severe bleeding. However, until Praxbind was approved in 2015, there wasn't a safe and reliable way to reverse Pradaxa's blood-thinning effects, which led to numerous hospitalizations and deaths.

If you were hospitalized for or lost a loved one to an uncontrollable Pradaxa bleeding event, you may be eligible to seek compensation for your losses, both economic and non-economic, from Boehringer Ingelheim.

The McGartland Law Firm has handled injury cases all across the United States for the past 30 years. This is the experience you need to take on an international corporation. Contact us today to schedule a free initial appointment to discuss your case.