Pradaxa, also known by the generic name dabigatran, is an anticoagulant medication.

These medications can be useful to prevent blood clot-related complications like stroke or systemic embolism in patients who are at risk for such conditions.

Like other anticoagulants, Pradaxa is frequently prescribed to reduce the risk of stroke associated with atrial fibrillation, a condition that makes the heart’s rhythm irregular.

These irregular heartbeats can cause blood to pool inside the heart. The stagnant blood may form clots that can travel to the brain and cause a stroke.

Patients who recently underwent hip or knee replacement surgery can also be at risk for other clot-related conditions like pulmonary embolism or deep venous thrombosis.

Anticoagulants like Pradaxa can help prevent these conditions by inhibiting the blood’s ability to clot. But that same effect also inhibits the body’s natural mechanism for controlling bleeding, putting patients at risk for Pradaxa internal bleeding side effects.

When Pradaxa was approved by the FDA in 2010, it was the first anticoagulant in decades to enter a market that had been dominated by warfarin since the 1950s.

Pradaxa was soon followed by a few other new oral anticoagulants, all of which had been specifically designed to avoid certain drawbacks associated with warfarin.

In particular, these new drugs were specifically designed so that they would not need the regular blood testing and dosage adjustment associated with warfarin.

But unlike warfarin, these drugs were introduced to the market without an antidote. Warfarin’s anticoagulant effect can be reduced by administering vitamin K.

The new drugs, however, were made available with no similar way to get bleeding under control.

Pradaxa was on the market for about five years before the FDA finally approved an antidote.

During that time, Pradaxa patients simply had to live with the risk of suffering uncontrollable Pradaxa internal bleeding side effects.

Reports Detail Pradaxa Internal Bleeding Side Effects

According to a study by the Institute for Safe Medication Practices, hundreds of cases of Pradaxa internal bleeding side effects were reported to the FDA in the drug’s first year on the market.

The Institute says that 932 serious adverse events associated with Pradaxa were reported to the FDA in the first quarter of 2011.

These included 543 cases requiring hospitalization and 120 that ended in death.

Hemorrhage was reported in 505 of those cases – hundreds more than were reported in association with warfarin, which ranked second with 176 cases. Bleeding incidents were particularly frequent among elderly patients.

By December 2011, reports of Pradaxa internal bleeding side effects had led the FDA to begin a safety review of Pradaxa adverse event reports.

These bleeding injuries associated with Pradaxa ultimately drove thousands of patients to initiate legal claims against Boehringer Ingelheim, the drug’s manufacturer.

Plaintiffs alleged the company didn’t do enough to warn them about the risks of uncontrollable bleeding associated with the drug.

So many claims were filed that the federal court system consolidated them all into a single multidistrict litigation.

In May 2014, Boehringer Ingelheim worked out a mass settlement of over 4,000 such claims, to the tune of $650 million. The settlement came just before the first few claims were scheduled to go to trial.

New claims are expected to keep rolling in, however. As Pradaxa patients continue to suffer internal bleeding side effects, Boehringer Ingelheim is expected to face a new wave of claims – this time mainly in state courts.