The blood thinner Pradaxa is prescribed to prevent blood clots and stroke in patients with atrial fibrillation or who have undergone surgery. Many patients now associate it with severe bleeding complications.

Pradaxa was introduced to the market with much anticipation, with manufacturer Boehringer Ingelheim Pharmaceuticals promoting it as a safer alternative to warfarin.

Used primarily by people who suffer from atrial fibrillation, or an irregular heartbeat, this new generation blood thinner is supposed to minimize the risk of suffering from a stroke and other serious problems.

Concerns Over Pradaxa Side Effects

One of the major concerns regarding Pradaxa side effects is that if an internal bleed is discovered, there is no known Pradaxa antidote as there is for warfarin.

For instance, if a patient overdoses on warfarin and starts to bleed, the effects can be quickly reversed with a dose of Vitamin K. However, if a patient overdoses on Pradaxa and starts bleeding, there’s nothing anyone can do but wait for their kidneys to process the blood thinner and excrete it in the urine — a process that takes hours at best, potentially long if the anticoagulant has slowed kidney function, as many expect it can.

This lack of a reversal agent for Pradaxa complications make internal bleeding events far more deadly.

Pradaxa Bleeding Complications

People at the highest risk for uncontrollable Pradaxa bleeding include patients who are 75 years old or older, have existing kidney problems, have stomach bleeding or an ulcer, or who are taking other drugs that increase the risk of bleeding, including aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), and other blood thinners.

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

• unusual bleeding from the gums
• nose bleeding that happens often
• menstrual or vaginal bleeding that is heavier than normal
• bleeding that is severe or you cannot control
• pink or brown urine
• red or black stools (looks like tar)
• bruises that happen without a known cause or that get larger
• coughing up blood or blood clots
• vomiting blood or vomit that looks like coffee grounds

Pradaxa Lawsuits

While the FDA approved Pradaxa in 2010, it did not mandate regular monitoring in patients, according to several Pradaxa lawsuits. This could have been an opportunity to make the product safer.

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 agency had initially maintained that Pradaxa and other blood thinner medications were equal in terms of bleeding risks. Many of these reported Pradaxa complications have led to Pradaxa lawsuits being filed against the drug’s manufacturer.

If you or someone you love has suffered from adverse and life-threatening Pradaxa complications such as internal bleeding, you may be entitled to file a Pradaxa lawsuit to recover damages for your conditions.