Pradaxa and its Side Effects

Pradaxa, or dabigatran, belongs to a class of drugs called direct thrombin inhibitors.  Manufactured by the German pharmaceutical company Boehringer Ingelheim, Pradaxa, prescribed to patients with non-valvular atrial fibrillation (AF) to prevent blood clots and reduce the risk of stroke, was the first FDA-approved anticoagulant (anti-blood clotting agent) in over 50 years. By limiting the actions of the protein thrombin, an enzyme that encourages clot formation, Pradaxa inhibits thrombin and, therefore, prevents clot formation.   While beneficial in stroke prevention, because it is an anticoagulating drug, Pradaxa users suffer serious side effects.  Even after a minor injury like a fall or cut, patients on Pradaxa are unable to stop bleeding. This easily occurring and often uncontrolled bleeding leads to weakness, easy bruising, unusual bleeding from any body part including nose, mouth, vagina, or rectum, blood in cough or heavy menstrual bleeding. Some patients may also have purple or red spots on skin, pink or brown urine, bloody or tarry stools, joint pain or swelling or feeling like passing out.  In some cases, the results are fatal.

Approved on October 19, 2010, after Boehringer Ingelheim presented evidence that they concluded showed Pradaxa’s efficacy. In a clinical trial encompassing 18,113 patients from 44 countries where users of Pradaxa and its predecessor warfarin (brand names Jantoven, Marfavin, and Coumadin) were compared, bleeding occurred at the same rate, but those using Pradaxa had fewer life-altering side effects.  In response to this clinical trial, Boehringer Ingelheim, in a press release dated October 27, 2010, stated the “results demonstrated that dabigatran etexilate [Pradaxa] 150mg significantly reduced the risk of stroke and systemic embolism by 35 percent beyond the reduction achieved by warfin.”

Initially, Pradaxa was touted a wonder drug because, unlike warfarin, Pradaxa does not require constant dosing adjustment and monitoring by doctors, and it has fewer drug and food interactions. From October 2010-August 2011, approximately 1.1 million prescriptions were filled to over 371,000 patients.  Quickly, though, problems began to surface among Pradaxa users.  Even though Boehringer Ingelheim continued to claim that Pradaxa provided “superior efficacy,” in the second quarter of 2011, 856 reports of serious, disabling or fatal injury were revealed to the FDA. The Institute for Safe Medicine Practices (ISMP) also disclosed that the “FDA received 3,781 adverse event reports associated with Pradaxa in 2011, more than were associated with any other drug the agency monitors.”  Pradaxa may require less monitoring; yet, unlike warfarin, Pradaxa has no known reversal agent; once a patient on Pradaxa begins bleeding, there is little treatment for stopping blood flow. Pradaxa causes an increased risk of internal bleeding and hemorrhaging, often with fatal results—results Boehringer Ingelheim was neglected to reveal to patients and physicians.

Have You Been Affected by Pradaxa?

Any individual or the relative of an individual who has suffered due to Pradaxa’s side effects is permitted to file a lawsuit.  The lawyers can help you determine whether you are qualified to seek compensation. You may be eligible to seek reimbursement for medical expenses, compensation for pain and suffering, and punitive damages (compensation granted for losses suffered).

Different states have different legislation regarding medical lawsuits, so it is essential to hire an experienced and effective lawyer who can file the case. If you need further information about the harmful side effects of Pradaxa or legal advice concerning personal injury matters, you are invited to us fill out the form on this website for a free case evaluation.

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