History of Pradaxa
Approved by the U.S. Food and Drug Administration (FDA) in October 2010, Pradaxa was marketed as a superior alternative to warfarin, which has been the go-to blood thinner in the United States for decades, because it supposedly requires less maintenance than the older anticoagulant and was designed to have fewer side effects. After just one year on the market, Pradaxa was being prescribed to 16% of patients with atrial fibrillation, compared to 44% of patients taking warfarin, and by August 2012, more than 3.7 million prescriptions had been filled for Pradaxa in the United States.
The problem with Pradaxa became evident just two years after it was approved by the FDA, when the anticoagulant drug was blamed for more than 500 patient deaths involving hemorrhages and uncontrollable bleeding. In May 2014, the FDA issued a drug safety communication warning Pradaxa users that the blood thinner was associated with a 28% higher risk of gastrointestinal bleeding complications compared to warfarin, lower rates of stroke and death, and similar rates of heart attack. In a 2014 study published in the medical journal Circulation, researchers found an 85% increased risk of gastrointestinal problems in patients taking Pradaxa.
Reported Side Effects of Pradaxa
- Uncontrollable bleeding
- Gastrointestinal bleeding
- Internal hemorrhaging
- Brain hemorrhages
- Heart attack
- Liver failure
- Wrongful death
What is Pradaxa?
Pradaxa (dabigatran) is a new-generation anticoagulant drug commonly prescribed to treat patients with atrial fibrillation who are at an increased risk for blood clots and stroke. Unlike warfarin, which thins the blood by decreasing the activity of vitamin K, Pradaxa inhibits the action of a clotting protein called thrombin, which reduces the body’s ability to form clots. The main difference between Pradaxa and warfarin though, is that, while vitamin K can be administered to reverse the blood-thinning effects of warfarin in the event of an internal bleeding complication, there is no reversal agent for Pradaxa, which means doctors are often unable to control Pradaxa bleeding side effects.
Reasons for a Pradaxa Lawsuit
Pradaxa personal injury and wrongful death lawsuits allege:
- Boehringer Ingelheim manufactured a defective and unreasonably dangerous medication.
- The drug maker negligently released a blood thinner without an antidote.
- The drug maker failed to adequately warn patients and doctors about the risk of uncontrollable bleeding from Pradaxa.
- The drug maker failed to provide accurate dosing information for Pradaxa users.
- The drug maker misrepresented the safety and effectiveness of Pradaxa compared to warfarin.
Pradaxa Lawsuit Information
While bleeding that may lead to serious or even fatal outcomes is a known side effect of all anticoagulant drugs, research has shown that patients taking Pradaxa may face a higher-than-expected risk of severe bleeding complications, and because there is no approved antidote for Pradaxa, these bleeding events can sometimes be deadly. As a result of these findings, thousands of former Pradaxa users across the country have filed product liability lawsuits against Boehringer Ingelheim, and in May 2014, the drug company agreed to pay $650 million to settle more than 4,000 complaints brought over Pradaxa injuries and deaths.
Pradaxa lawsuits filed against Boehringer Ingelheim allege that the drug manufacturer failed to provide adequate warnings about the potential for the anticoagulant medication to cause serious or deadly bleeding complications in users. Plaintiffs also accuse the manufacturing company of overstating the benefits of Pradaxa in its marketing materials, claiming that the blood thinner was safer, easier and more convenient than warfarin, when, in fact, studies have linked Pradaxa to a higher risk of heart attacks, heart disease and other serious health complications compared with warfarin.
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