Pradaxa (dabigatran) is one of the most popular anticoagulant medications in the United States, helping millions of patients since its release in 2010.

However numerous patients have complained of Pradaxa adverse side effects, including complaints of near fatal internal bleeding injuries.

Pradaxa was the first medication approved for anticoagulant purposes since warfarin’s release in the 1950s.

But, patients have been reporting Pradaxa adverse side effects since its release, causing numerous complaints to be submitted to manufacturer Boehringer Ingelheim.

The Pradaxa adverse side effects reported include gastrointestinal bleeding and brain bleeding, with each patient requiring hospitalization.

The FDA had released a public warning regarding Pradaxa adverse side effects in December 2011, stating that patients can suddenly suffer internal bleeding attacks.

Since the warning, there have been numerous studies conducted comparing Pradaxa to its predecessor, warfarin.

Overview of Pradaxa Adverse Side Effects

These studies were conducted to determine the safety profile of Pradaxa, each of which found that Pradaxa was more likely to cause internal bleeding events than warfarin.

It is important to note that unlike warfarin, Pradaxa and other new generation anticoagulants have no widely available reversal agents in the case of internal bleeding.

One of the most recent studies was published in 2014, in the medical journal Circulation. Researchers analyzed over 134,000 Medicare patients prescribed either Pradaxa or warfarin to treat their atrial fibrillation.

The study found that Pradaxa had lower risk of brain hemorrhage compared to warfarin, but had increased risk of major stomach bleeding.

Another 2014 study published online in JAMA Internal Medicine found similar results, with researchers also comparing Medicare patients prescribed Pradaxa or warfarin.

This study was also meant to compare warfarin and Pradaxa adverse side effects. The study looked at  over 1,300 patients who were prescribed Pradaxa and 8,000 patients who had been prescribed warfarin.

The study found that 9% of patients in the Pradaxa group suffered major bleeding, compared to the 5.9% of Warfarin patients.

The researchers in this study ultimately recommended that further inquiry was needed to determine the true safety profile of Pradaxa, and that physicians should be wary against potential internal bleeding events.

Pradaxa patients should also be vigilant for any signs of internal bleeding including:

• Bleeding from gums
• Vomiting blood
• Pink or brown urine
• Black or red stool
• Coughing up blood
• Headache or vision problems

Many experts believe the widespread problems of Pradaxa adverse side effects stem from the drug’s convenient prescription regime.

In contrast to Pradaxa, warfarin patients are required to frequently see their doctors for dose adjustments. Pradaxa and other new generation anticoagulants are prescribed in one dose, making the newer blood thinner significantly more popular.

Even though these Pradaxa adverse side effects can be potentially fatal, Boehringer Ingelheim allegedly failed to disclose this safety information.

Pradaxa patients who may have suffered internal bleeding injuries may be able to file legal action against the company. Potential claimants should contact a specialized lawyer to determine eligibility.