Since its FDA approval in October 2010, Pradaxa has been prescribed to more than 300,000 patients in the United States.

However, the drug has been linked to excessive bleeding, heart attacks, and other serious blood thinner risks.

What is Pradaxa For?

Pradaxa is a blood thinner made by Boehringer Ingelheim for patients suffering from non-valvular atrial fibrillation (AF). It is also prescribed to people who suffer from stroke or from excessive blood clotting.

Specifically, Pradaxa belongs to a class of drugs that are known as direct thrombin inhibitors. These drugs inhibit the production of an enzyme in the body so that excessive blood clotting can be prevented and the risk of strokes can be reduced.

When Pradaxa (dabigatran) first appeared on the market, it seemed like a better alternative to its predecessor warfarin because it required less monitoring and no dietary restrictions.

Between its release in October 2010 and August 2011, more than 1 million prescriptions of the drug were dispensed to more than 370,000 patients.

Praxada Side Effects

The more common side effects of taking Pradaxa may include:

• Stomach pain
• Nausea
• Heartburn
• Headache

Mild to moderate Pradaxa side effects may also include:

• Unusual bruising or bleeding
• Pink or brown urine
• Red or maroon colored stool
• Coughing or vomiting blood
• Bleeding from the gums
• Frequent nosebleeds
• Heavy menstrual bleeding
• Joint pain or swelling
• Dizziness or feeling of weakness
• Rash, hives, or other skin itching or irritation
• Difficulty breathing or swallowing
• Swelling of extremities
• Upset stomach
• Heartburn
• Vomiting
• Diarrhea
• Skin irritation

While less common, it’s the more major Pradaxa side effects that have made headlines in recent years. People who’ve filed Pradaxa lawsuits contend that Boehringer Ingelheim released an unsafe product to market that has caused:

• Severe or uncontrollable bleeding (particularly internal bleeding or internal hemorrhaging) is among the most serious side effects of taking Pradaxa. A clinical study, known as RE-LY, designed to examine the effects of Pradaxa, found that up to 16.4% of people taking the drug may experience bleeding. Of those individuals, 3.3% experience serious bleeding and 1.5% experience life threatening bleeding.
• Gastrointestinal problems are experienced by up to 35% of people prescribed Pradaxa. Such problems include abdominal pain, digestive tract ulcers, gastroesophageal reflux disease, black or tarry stools, indigestion, and more. While some of these Pradaxa side effects are considered minor, others constitute a serious medical emergency.
• Heart attacks are another major side effect associated with Pradaxa. According to a 2012 study conducted by the Cleveland Clinic, the risk of a heart attack or other heart complications rose 33% in patients taking the blood thinner.

In some cases, these Pradaxa side effects can be fatal.

What made Pradaxa blood thinner risks particularly deadly is that unlike warfarin, there was no approved antidote to reverse or stop bleeding until last October, five years after Pradaxa was released onto the market.

If a patient has overdosed on warfarin and starts to bleed, the effects can be quickly reversed with a dose of Vitamin K. Prior to Praxabind, if a Pradaxa patient started bleeding internally, there was nothing anyone could do but wait for their kidneys to process the drug and excrete it in the urine, a process that can be dangerously long.

With Praxabind, the new antidote to Pradaxa, these bleeding events will hopefully be more effectively controlled, but since the reversal agent is in its relative infancy, its broad clinical efficacy is yet to be determined.

Pradaxa Lawsuits

Many patients who have taken the anticoagulant and experienced adverse Pradaxa side effects have filed lawsuits against the drug manufacturer.

If you have taken Pradaxa and believe that it harmed you, or a loved one passed away and you believe their death to be caused by the blood thinner, an experienced drug injury lawyer can help you determine if you should file a lawsuit against the drug maker.