Despite being designed as an improvement over older medications, Pradaxa still presents patients with a risk of blood thinner side effects.

One of the blood thinner side effects of Pradaxa that has been particularly controversial is the increased risk of excessive bleeding.

This risk is unavoidable with any anticoagulant medication, because the same action that reduces the risk of stroke and embolism also reduces the body’s natural ability to slow and stop bleeding.

The reduction in the blood’s ability to clot can lead to severe internal bleeding injuries like gastrointestinal bleeding and intracranial hemorrhage.

Bleeding in these cases can be so profuse as to be fatal. It’s a risk that makes management of Pradaxa treatment tricky for the physicians who prescribe it.

Aggravating the risk is the lack of available antidotes that can keep the new oral anticoagulants under control. For the first several years that Pradaxa was on the market, there was no antidote available to counteract its anticoagulant effect.

This lack of an antidote was one drawback that Pradaxa did not share with warfarin, the older drug that Pradaxa was designed to compete with. Warfarin’s anticoagulant effect can be reduced by administering vitamin K.

So when patients taking warfarin suffered sudden and excessive bleeding, or if they developed an unexpected need for emergency surgery, a dose of vitamin K could help keep their bleeding under control.

Until recently, Pradaxa patients had no such option. If they suffered from uncontrollable bleeding while taking Pradaxa, they might have had to undergo dialysis or a blood transfusion to get the Pradaxa out of their blood.

Administering an antidote was not an option for Pradaxa patients until only recently. An antidote for Pradaxa called Praxbind was finally approved by the FDA in October 2015 – after Pradaxa had been on the market for about five years.

This antidote came too late for patients who had already suffered dangerous blood thinner side effects while taking Pradaxa.

Pain Meds May Aggravate Blood Thinner Side Effects

Adding to the bad news is the fact that ordinary, over-the-counter pain killers can make the risk of Pradaxa bleeding worse.

That might not be news to anticoagulant patients whose painkiller of choice is aspirin. Asprin has long been known to increase the risk of bleeding associated with these drugs.

But non-steroidal anti-inflammatory drugs like Advil and Aleve may have the same effect. Published in April 2014 in JAMA Internal Medicine, one study found that patients who took an NSAID while also taking an anticoagulant faced 2.4 times the risk of major bleeding – compared to an increase of 1.5 times for those who took aspirin.

Pradaxa Litigation

Thousands of Pradaxa patients who allegedly suffered blood thinner side effects looked to the legal system to get recourse for their injuries.

In the federal court system, the number of Pradaxa lawsuits grew large enough that the Judicial Panel on Multidistrict Litigation consolidated cases from around the country into a single multidistrict litigation, or MDL, to be conducted in the District Court for the Southern District of Illinois.

By May 2014, the number of cases had reached around 4,000. Faced with the prospect of trial scheduled to begin soon, Pradaxa’s manufacturer Boehringer Ingelheim settled all cases in the MDL for a total of around $650 million.