Pradaxa (dabigatran) is one of a class of anticoagulants (blood thinners) called direct thrombin inhibitors. Pradaxa was approved by the Food and Drug Administration in October 2010 as an allegedly new and better alternative to an existing blood thinner, Coumadin (warfarin).

Whereas warfarin had to be taken twice a day, Pradaxa was designed to be taken once a day. Drug manufacturers and salespeople reportedly advertised the drug as more convenient both for patients and prescribing doctors.

Pradaxa was marketed as superior to warfarin because it required less monitoring of a patient who was using it, and unlike in the case of warfarin, required very little change of diet to be effective. But research has shown that patients are at risk for a number of potentially serious and life threatening side effects, particularly bleeding with Pradaxa.

Experts further allege that the dosing of Pradaxa, while convenient, causes severe fluctuations in blood levels that are dangerous to patients, whereas blood levels in patients taking warfarin remained more stable.

Research suggests that these fluctuations are why there may be a higher risk of internal bleeding with Pradaxa than with warfarin in some patients. Patient advocates argue that the manufacturer did not sufficiently research the effects of the Pradaxa once-daily dosing before releasing it into the market.

Additionally, research shows that the consequences of bleeding with Pradaxa can be much more dire than the consequences of an internal bleed that occurs when a patient is taking warfarin.

Allegedly, when a patient taking warfarin experiences an internal bleed, it is possible to get the blood to clot normally by flushing the drug from the patient’s system with vitamin K. This is often a life-saving solution.

But for the first several years Pradaxa was on the market, patients did not have the option of an antidote that could help get excessive bleeding under control. It wasn’t until October 2015 that an antidote for Pradaxa was finally released.

In Pradaxa’s first three months on the market, the FDA received 307 reports of bleeding with Pradaxa and other serious health conditions. In the first year, over 260 deaths were reported that were allegedly linked to bleeding with Pradaxa.

Many patients say they were not adequately warned about the risk of bleeding with Pradaxa. Bleeding side effects reported by Pradaxa patients have included:

• Brain hemorrhage
• Death
• Gastrointestinal bleeding
• Heart attack
• Internal bleeding
• Kidney bleeding
• Stroke

Thousands of claims have been filed by patients who suffered bleeding from Pradaxa, claiming that Boehringer Ingelheim, the maker of Pradaxa, knew the drug was dangerous but sold it nonetheless. According to the bleeding from Pradaxa lawsuits, the company was negligent in not warning patients of the risks associated with the drug.

Contacting an experienced Pradaxa lawyer can help you determine if you have a legal claim. If you took Pradaxa and experienced Pradaxa side effects, joining a Pradaxa could help you receive compensation for injury.