Pradaxa, also known generically as dabigatran, is one of a small group of new anticoagulants approved by the FDA in recent years.

These drugs were developed to offer certain advantages over warfarin, which for decades had been a mainstay anticoagulant with no real competitor on the market.

Warfarin has a few drawbacks that the pharmaceutical companies wanted to avoid with their own drugs.

Since the correct dose of warfarin is unique to each person and must be very precise, patients using that drug need to undergo periodic blood testing and dosage adjustment.

Pradaxa and the other new drugs were designed to avoid this problem. They were also marketed as having fewer interactions with other drugs, and when discontinued their effect wears off faster than warfarin’s does.

Anticoagulants see a large amount of use in patients with atrial fibrillation, a condition that puts the patient at risk for blood clot related injuries like stroke. Anticoagulants mitigate that risk by reducing the blood’s ability to clot.

The flip side of that effect is an increased risk of bleeding for patients who take anticoagulants. These drugs as a group put patients at an increased risk for injuries like hemorrhagic stroke and internal bleeding in the stomach.

And unlike warfarin, whose anticoagulant effect can be reduced by administering vitamin K, the new anticoagulants were introduced with no available antidote that could help get bleeding under control in case of emergency.

FDA: Internal Bleeding in the Stomach More Common with Pradaxa

Some studies show that Pradaxa may not offer greater safety compared to warfarin as far as gastrointestinal bleeding is concerned.

In May 2014, the FDA announced the results of its own study of the results of different anticoagulants in thousands of Medicare patients.

Specifically, the agency sought to compare Pradaxa to warfarin. FDA researchers found a higher incidence of internal bleeding in the stomach in patients who had taken Pradaxa than in those who were on warfarin.

Compared to the results from an earlier and smaller study, those from the new Medicare study showed a higher frequency of internal bleeding in the stomach among new users of Pradaxa, the agency said.

The new findings were also consistent with those from another study known as the RE-LY trial. That study also showed an increase in the instance of internal bleeding in the stomach as patients increased in age.

Bleeding injuries like these have been at the center of thousands of legal claims against Boehringer Ingelheim, the manufacturer of Pradaxa.

Plaintiffs generally claimed that Boehringer Ingelheim had failed to adequately warn them about the risk of bleeding injuries associated with Pradaxa. Some took issue with the fact that at the time they took Pradaxa, there was no antidote available on the market.

So many claims were filed that in August 2012, the federal court system consolidated them into a single multidistrict litigation to be managed by a single court in Illinois. By May 2014, that MDL had resulted in a single massive settlement offer from Boehringer Ingelheim.

Although the company continued to deny liability, it agreed to pay a total of $650 million to settle an estimated 4,000 Pradaxa lawsuits.