Pradaxa lawsuits claim the blood thinner’s manufacturer failed to warn patients about the drug’s high risk of severe bleeding. Early Pradaxa patients were at risk of bleeding to death, as there was no antidote for years. Pradaxa patients have filed 4,000+ lawsuits against Boehringer Ingelheim. Many of these lawsuits were resolved as part of a $650 million settlement.
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Everything You Must Know About Pradaxa
Pradaxa Lawsuit Brief
In recent years, concern over the blood thinner Pradaxa has led thousands of people to file lawsuits against Boehringer Ingelheim, the drug’s manufacturer. The primary claim against the pharmaceutical company is that it failed to warn consumers about the medication’s high risk of severe bleeding.
Many lawsuits against Pradaxa refer to the fact that for the first five years Pradaxa was available to the public, no antidote existed to reverse the effects of the drug. Patients who took the anticoagulant could potentially bleed to death from an otherwise minor injury. Bruising and internal bleeding could also cause major health issues for people taking the drug.
Serious Pradaxa Side Effects
The most common complaints in Pradaxa lawsuits reference dangerous side effects of the blood thinner, the most serious of which is a higher risk of severe bleeding that can lead to death.
Initially approved by the U.S. Food & Drug Administration (FDA) in 2010, Pradaxa (apixaban) was marketed by Boehringer Ingelheim as an alternative to warfarin, the most commonly used blood thinner in the preceding 60 years. Some studies showed that Pradaxa could treat certain conditions (such as atrial fibrillation and stroke) better than warfarin, and a number of other studies have shown that Pradaxa and other newer anticoagulants like Xarelto may cause fewer overall bleeding events than warfarin for some patients.
However, the important difference is that although warfarin could be reversed with a relatively straightforward vitamin K treatment, Pradaxa had no antidote for the first several years it was available. As a result, many patients suffered from severe or prolonged bleeding events while taking Pradaxa, which they may not have had to endure when taking warfarin. Many Pradaxa lawsuits filed cite the lack of an antidote and a risk of severe bleeding as the primary reason for filing a legal claim.
Secondary Effects of Pradaxa
Pradaxa lawsuits also often refer to secondary effects caused by excessive bleeding from taking the drug. For example, some patients who took Pradaxa claim they experienced unnecessary pain and suffering due to the extended amount of time it took for wounds to heal while the anticoagulant was still active. Prolonged bleeding could also lead to other complications, requiring painful procedures and expensive treatments. Also, extended hospital stays could lead to further potential problems, such as a higher risk of infection or mental health issues.
These secondary effects can vary greatly among individuals who experience severe bleeding events after taking Pradaxa, and some people may not experience any of them. However, in each case, plaintiffs argue that they likely would not have suffered any of these secondary side effects, or the secondary effects would have been less severe, had they not taken Pradaxa.
Design, Manufacturing and Marketing Defects
The FDA approved Pradaxa based largely on the results of a clinical trial called Randomized Evaluation of Long-term Anticoagulant Therapy (RE-LY), which was sponsored by Boehringer Ingelheim. RE-LY concluded that dabigatran – the active ingredient in Pradaxa – caused fewer bleeding events than warfarin, and was, therefore, safer to use in comparison with the longer-used drug. The drugmaker then promoted its new prescription as an improvement over the more popular anticoagulant. Unlike warfarin, Pradaxa had fewer interactions with foods and other drugs, and it did not require weeks of calibration to determine the right dosage.
Sources: Consumer Safety
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