New research suggests that Pradaxa dangers such as gastrointestinal bleeds may be more common than previously thought.

Pradaxa is one of the new generation of anticoagulant medications that were developed to compete with warfarin, which had been medicine’s go-to anticoagulant for decades.

Despite warfarin’s long tenure, it has its problems. To ensure the dosage is high enough to be effective but not so high as to create an excessive risk of bleeding injuries, patients taking warfarin must submit to regular blood tests and, if needed, adjustments in their dosage.

These patients must also avoid eating certain foods with vitamin K, which can counteract warfarin’s anticoagulant effect.

Enter Pradaxa. Approved by the FDA in 2010, it was the first of the new generation of oral anticoagulants to hit the market. Pradaxa was specifically developed so that patients would not need to undergo blood testing or submit to dietary restrictions.

Having a new alternative to warfarin was a welcome development for millions of anticoagulant users and their treating physicians. Among other applications, anticoagulants are used by patients with atrial fibrillation to reduce the risk of stroke associated with that condition – a condition that affects millions of U.S. patients.

Researchers Keep Tabs on Pradaxa Dangers

Results of earlier clinical studies of Pradaxa seemed positive. Data showed Pradaxa was at least as effective as warfarin at preventing the blood clots that can cause stroke. Researchers thought Pradaxa might also present less of a risk of bleeding side effects.

But more recent studies show a higher risk of Pradaxa dangers. Not long  after Pradaxa was introduced to the market, reports of excessive bleeding events associated with the drug began to be filed with the FDA. The agency responded by ordering a new round of research into Pradaxa dangers.

One study, conducted by the University of Pittsburgh and published in the journal JAMA Internal Medicine, surveyed 9,400 Medicare-covered patients who suffered from atrial fibrillation. Within that group, 1,300 took Pradaxa and 8,100 took warfarin.

The researchers found that major bleeds occurred among the Pradaxa users at a rate of 9 percent, compared to 6 percent among warfarin users. Pradaxa patients were also more likely to suffer bleeding within the stomach, the researchers reported.

Litigation Over Pradaxa

Thousands of patients who suffered bleeding injuries more severe than they expected have responded with a wave of Pradaxa lawsuits against Boehringer Ingelheim, the drug’s manufacturer.

Plaintiffs in these claims say the company failed to adequately warn them about Pradaxa dangers. Had they been given a better idea of the risks involved in Pradaxa treatment, they say, they could have avoided those risks by not taking Pradaxa.

Plaintiffs also take issue with the fact that Boehringer Ingelheim released Pradaxa years before it had an available antidote that could reverse its anticoagulant effect.

Lack of an antidote has not been a similar problem for warfarin users, since they can temper that drug’s anticoagulant effect by administering vitamin K. But until a Pradaxa antidote finally got FDA approval in October 2015, Pradaxa patients had no drug that could keep Pradaxa bleeding under control.