Pradaxa (dabigatran) is a blood-thinning drug approved by the FDA in 2010 as a new alternative to warfarin for treating atrial fibrillation, which can lead to stroke.

According to the FDA, over 3 million Americans have atrial fibrillation. Pradaxa has been prescribed to more than 850,000 patients to treat this condition, despite costing $300 monthly instead of only $4, the cost of generic warfarin. Many patients opt to use Pradaxa in spite of the increased cost because, unlike warfarin, it does not require frequent blood testing – a major selling point that has been broadly marketed by drug maker Boehringer Ingelheim.

Despite the company’s claims, however, recent studies and an investigation published in the July 2014 issue of the British Medical Journal suggest that more frequent blood testing with Pradaxa may help prevent major internal bleeding problems. These complications have led to thousands of Pradaxa lawsuits against the company.

With a lower dose of Pradaxa or warfarin, side effects such as the risk of internal bleeding are comparable between the two drugs. However, new information comparing the effects of Pradaxa and warfarin suggests that, at higher doses, Pradaxa may actually increase risk of major internal bleeding or brain hemorrhage.

Boehringer has stated since this information was released that Pradaxa still offers more benefits than risks. The company claims that there is no need for frequent blood testing.

The Institute for Safe Medication Practices indicates that, for older Americans, blood-thinning drugs such as Pradaxa or warfarin are some of the highest-risk treatments. While Pradaxa and warfarin can both cause internal bleeding or brain hemorrhaging, excess bleeding caused by warfarin can be counteracted. There are currently no available measures against excess bleeding caused by Pradaxa.

Symptoms of Pradaxa Complications

In lieu of frequent blood tests, patients taking Pradaxa or a similar treatment should be aware of the symptoms of internal bleeding. These symptoms include:

• unusual bleeding from the gums
• frequent nose bleeds
• pink or brown urine
• black or red stools
• coughing up or vomiting blood
• vomit that looks like coffee grounds
• heavier than normal vaginal bleeding

Symptoms of brain bleeding include:

• sudden weakness
• headache
• confusion
• vision problems

These alleged Pradaxa complications have spurred thousands of consumers into filing Pradaxa lawsuits accusing Boehringer of failing to adequately warn consumers about the bleeding risks of Pradaxa. Some plaintiffs allege these new studies reinforce the potential danger in taking Pradaxa, as well as the company’s alleged reluctance to deal with this issue.

If you or someone you know has experienced internal bleeding or brain hemorrhaging due to Pradaxa, you may have cause for filing a lawsuit.