Boehringer Ingelheim Pharmaceuticals introduced Pradaxa in October 2010. The drug was widely hailed in the medical community as a long-anticipated stroke preventative for patients with atrial fibrillation – a condition marked by an irregular heartbeat that dramatically increases stroke risk.

However, according to a study, doctors should exercise extreme caution when prescribing the anticoagulant medication.

A study published in the November 2014 issue of JAMA Internal Medicine warns that doctors should prescribe Pradaxa with caution, because of “a higher incidence of major bleeding” when compared with warfarin. Pradaxa patients had a 30 percent greater risk of any bleeding, 58 percent greater risk of major bleeding, and an 85 percent higher risk of gastrointestinal bleeding, the study found.

Rates of major Pradaxa bleeding were 9 percent, compared with 6 percent in warfarin patients, according to the study. But though Pradaxa patients were more likely to have gastrointestinal bleeding, a finding the FDA replicated in its own study, they were less likely to experience bleeding in the brain.

The FDA study concurred with the latter finding as well, with a reduction of risk of about 65 percent compared with warfarin. The JAMA study covered a fraction of the number of patients than the FDA study, but, according to the JAMA authors, it did one key thing that the FDA study didn’t: It accounted for differences between the warfarin patients and the Pradaxa patients that would otherwise bias the results.

The JAMA study authors say that the lower risk of intracranial bleeding is one big reason. It’s “arguably more serious than GI bleeding,” the study authors said, “so this agent is still clinically useful.”

The FDA study found that Pradaxa cut the risk of stroke by 20 percent, along with that 66 percent decrease in brain-bleed risk.

Still, the JAMA study findings raises concerns for Pradaxa users because it appears that the bleeding risk for Pradaxa is higher than for warfarin and significantly greater than how it originally appeared at the time of the FDA approval.

One thing that has been pointed out over and over is that Pradaxa, unlike warfarin, has no quick-acting, well-proven antidote.

The Dangers of Pradaxa

For nearly 60 years, warfarin (Coumadin) was the only such drug on the market, but maintaining the proper warfarin dosage is a notoriously difficult task that requires patients be subjected to frequent blood tests. Pradaxa is easier for doctors to administer and control.

While Pradaxa may seem like a welcomed alternative for doctors to prescribe and A-fib patients to take, the blood thinner can be devastating for Pradaxa patients suffering from a hemorrhage and the emergency room physicians trying to treat them. Unlike warfarin, which can be countered with vitamin K, there is no Pradaxa antidote.

Essentially this means that doctors can do little for hemorrhaging Pradaxa patients except make them as comfortable as possible while they bleed uncontrollably.

Such a grim scenario isn’t uncommon. In 2011, the U.S. Food and Drug Administration (FDA) received more reports of death and bleeding from Pradaxa than all other prescription drugs, according to an analysis conducted by the Institute for Safe Medicine Practices.

Pradaxa Lawsuits

Pradaxa internal bleeding lawsuits continue to allege that Boehringer Ingelheim Pharmaceuticals did not adequately warn patients of the alleged risk of severe internal bleeding linked to the drug, according to court documents. To date, no Pradaxa antidote has been found to stop Pradaxa bleeding incidents once they begin.

If you or someone you love has suffered from adverse and life-threatening Pradaxa complications such as internal bleeding, you may be entitled to work with Pradaxa lawyers and file a Pradaxa lawsuit to recover damages for your suffering.