Pradaxa (dabigatran) is a prescription blood-thinning medication that has been approved by the Food and Drug Administration (FDA) to reduce the risk of stroke in people with non-valvular atrial fibrillation.

Pradaxa is in a class of anticoagulant drugs called direct thrombin inhibitors, which attach to clotting agents in the blood and reduce its ability to clot. Unlike other blood thinners, like warfarin, Pradaxa doesn’t require monthly blood tests.

However, Pradaxa has no known counteracting drug, and this can make it more difficult to stop internal bleeding in patients who are taking Pradaxa.

Serious Pradaxa Bleeding Risks

The FDA recently began evaluating reports that internal bleeding is more common in patients using Pradaxa than in patients using other blood thinners. Boehringer Ingelheim Pharmaceuticals, the maker of Pradaxa, has reported 260 fatal internal bleeding events related to Pradaxa side effects between March 2008 and October 2011.

People at the highest risk for uncontrollable Pradaxa bleeding side effects include people who:

• are 75 years old or older,
• have existing kidney problems
• have stomach bleeding or an ulcer
• or are taking other drugs that increase the risk of bleeding, including aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), and other blood thinners

Alleged Pradaxa Side Effects

Pradaxa was brought to the market with great fanfare, with Boehringer touting it as being safer than traditional blood thinners like warfarin. Used primarily by people who suffer from atrial fibrillation, or an irregular heartbeat, Pradaxa is supposed to minimize the risk of suffering from a stroke and other serious problems.

One of the major concerns regarding Pradaxa side effects is that if an internal bleed is discovered, there is no known reversal agent as there is for warfarin.  Since there is no Pradaxa antidote for internal bleeding at this time, the risk of Pradaxa bleeding events are potentially far more deadly.

Pradaxa Bleeding Complications

Pradaxa users should call their doctors immediately if they notice any of the following Pradaxa side effects:

• Coughing up or vomiting blood
• Frequent nose bleeds
• Heavy menstrual bleeding
• Pink or brown urine
• Red or black stools

People taking Pradaxa shouldn’t stop using the drug without first talking to their doctors, as this can increase the risk of having a stroke.

Pradaxa Internal Bleeding Lawsuits

The FDA approved Pradaxa in 2010 and did not require regular blood monitoring in patients, according to several Pradaxa lawsuits. Unfortunately, some say that this could have been an opportunity to make the product safer.

Currently, the FDA is continuing to review Pradaxa side effects as well as other anticoagulants to evaluate the effectiveness and safety of the products, although the federal agency had initially maintained that Pradaxa and other blood thinner medications were equal in terms of bleeding risk.

If you or a loved one has taken Pradaxa and suffered from severe bleeding side effects resulting in hospitalization, or if a loved one died from cerebral hemorrhage or other life-threatening Pradaxa side effect, you may be able to file a Pradaxa internal bleeding lawsuit.