Pradaxa

Pradaxa (dabigatran) is a prescription anticoagulant, or blood thinner, designed to reduce the risk of stroke and blood clots.

Pradaxa was first approved by the FDA in 2010 as an alternative to another blood-thinning drug called warfarin. Pradaxa is typically prescribed to patients with heart and clotting disorders such as non-valvular atrial fibrillation, deep vein thrombosis (DVT) or pulmonary embolism (PE).

Although there have been over 17 million Pradaxa prescriptions in the United States, serious safety concerns have emerged. Complications such as uncontrolled bleeding, gastrointestinal hemorrhages and, more rarely, brain bleeding may occur.

Some of these side effects have prompted numerous FDA warnings and label updates. Many patients affected by these previously undisclosed risks have filed lawsuits.

This guide will explain what Praxada is, who takes it and what the safety concerns are for this popular medication.

Pradaxa is a direct thrombin inhibitor that helps reduce the formation of blood clots, especially in people with an irregular pulse (atrial fibrillation) that is not caused by a heart valve problem. The medication works by blocking thrombin, a key enzyme involved in the blood clotting process.

Pradaxa received FDA approval in October 2010 for stroke prevention in atrial fibrillation (AF) patients, and in 2015, the medication was also approved for treatment and prevention of DVT and PE.

Initially, Pradaxa was widely embraced by medical professionals and patients as a convenient alternative to warfarin. At that time, Warfarin was the only oral anticoagulant available in the U.S. for stroke reduction.

While warfarin requires patients to undergo regular blood tests and maintain a strict diet, Pradaxa eliminates those inconveniences and allows patients more freedom and flexibility.

Like many medications, Pradaxa use has side effects, some of which are more common than others. Common side effects include:

The medication can also cause rare side effects, including:

Pradaxa is also linked to some serious and potentially fatal risks, including:

Before the development of Pradaxa reversal agents — a substance that can counter the effects of another drug — there was no means to reverse the effects of Pradaxa, unlike Warfarin, which had a reversal agent. Many people died as a result of uncontrolled bleeding when medical care providers were unable to do anything to stop it.

Because of the serious risks associated with Pradaxa, the medication has a black box warning.

Black box warnings are prominently displayed on medication labels that warn about serious adverse reactions — particularly those that may lead to death or serious injury.

Pradaxa’s black box warning alerts patients to the potential risk of:

The FDA first issued a Drug Safety Communication on December 7, 2011, alerting consumers to reports about serious bleeding in Pradaxa users. There were numerous additional FDA communications since then, including but not limited to the following:

Unfortunately, many patients had already been affected before these label updates.

When Pradaxa first came onto the market, there were no reversal agents. This means there was no effective way to stop uncontrolled bleeding caused by Pradaxa.

In 2015, the FDA granted accelerated approval for a drug called Praxbind (idarucizumab), which was the first reversal agent for Pradaxa-related bleeding. When preliminary evidence suggests a drug can address a medical need that other approved medications can’t, it may be granted accelerated approval to meet that demand. Although accelerated approval requires less evidence than the typical approval process, Praxbind did get full approval later in 2018.

Praxbind works by binding to dabigatran and neutralizing its anticoagulant effects within minutes. This medication can be used in cases where a patient taking Pradaxa requires emergency surgery or if a Pradaxa user develops uncontrolled bleeding.

Despite Praxbind’s use as an emergency option, it did not eliminate legal concerns nor help the patients or their families who had been affected by Pradaxa-related complications before the release of Praxbind.

Despite the risks associated with Pradaxa, the medication was never recalled.

A 2012 FDA recall did occur and affected a single lot of the medication. The recall was prompted by a packaging defect that could potentially compromise the integrity of the medication by allowing moisture to get into the packaging.

In 2023, Ascend Laboratories LLC. also recalled Dabigatran Etexilate Capsules due to elevated levels of N-Nitroso-dabigatran. Although this chemical is commonly found in places like drinking water and vegetables, high doses can potentially cause cancer. The recalled capsules included a generic version of Pradaxa.

Pradaxa’s manufacturer, Boehringer Ingelheim Pharmaceuticals, was sued by thousands of patients for allegedly failing to disclose the risk of serious complications. In their Pradaxa lawsuits, plaintiffs claimed that the company:

Boehringer Ingelheim Pharmaceuticals settled the majority of claims in 2014 and the remainder of the claims in 2020. The company paid out $650 million in settlements, with the average compensation per person being around $160,000.

What Patients Should Know and Do Next

Patients who use Pradaxa should consult their doctors if they experience any unusual symptoms, including unexplained bruising, bloody urine or fatigue. These symptoms could be a sign of internal bleeding or other complications. Patients are also advised to monitor both kidney function and clotting parameters, especially if they are long-term users.

If patients experience complications, they should report them to the FDA’s MedWatch program. Speaking with an experienced attorney can help you understand your legal options if you suffered harm from Pradaxa.