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Pradaxa Bleeding Complications Increase with Dosage, Study Says

According to a new study published in Circulation, a journal of the American Heart Association, the number of patients who experience Pradaxa bleeding complications increases as patients are given higher dosages of the drug. The study followed up with patients who had participated in a large clinical trial called RE-LY that attempted to measure the safety and efficacy of Pradaxa as well as the rate and severity of Pradaxa side effects. According to the study, 3% of these patients experienced a major bleeding event per year on the smaller dose (110 mg dabigatran) and 3.75% suffered a major hemorrhage on the larger dose (150 mg).

Study finds safety and efficacy tradeoff

Pradaxa is an anticoagulant, or blood thinner, designed to prevent strokes and other harmful clotting events in high-risk patients. The drug is only approved for use in patients with a particular kind of heart arrhythmia because their risk of stroke is considered to be higher than the risk of Pradaxa bleeding complications. Because Pradaxa works by preventing blood from clotting, it makes patients prone to bleeding and makes any injury a potentially serious and life-threatening event.

Although patients taking 150mg doses of Pradaxa in clinical trials experienced a higher rate of major bleeding events, they also suffered slightly fewer strokes and as a result did not have a significantly higher rate of death than patients taking lower doses. While Pradaxa manufacturer Boehringer Ingelheim insists the drug is safe, some who have taken Pradaxa have filed lawsuits claiming that the drug is unreasonably dangerous and that if they had known that the risk of dying of Pradaxa bleeding complications was just as high as the risk of dying from stroke, they would never have taken the drug.

Irreversible Pradaxa side effects

Pradaxa was approved by the FDA in 2010 and has been marketed as an alternative to warfarin, or Coumadin, ever since. Proponents of the drug say that it requires less monitoring than warfarin because it has fewer food and drug interactions. However, many doctors have expressed alarm about the fact that unlike warfarin, Pradaxa does not have a reversal agent that doctors can use to stop bleeding in case of emergency.

If a patient taking warfarin comes to the emergency room with uncontrolled bleeding, doctors administer vitamin K in order to counteract the drug and allow the blood to clot and the bleeding to stop. Doctors treating patients taking Pradaxa have no such option, and some ER doctors have had to watch their patients bleed to death from very minor injuries because they were unable to stop the bleeding caused by Pradaxa.

Pradaxa side effects lawsuits

Over a thousand federal Pradaxa lawsuits have been filed against Boehringer Ingelheim by patients and their families, alleging injuries ranging from GI bleeding and anemia to heart failure, brain bleeding, and death. These lawsuits claim that the company was negligent in failing to test its product adequately and negligent or fraudulent in presenting the product as safe without providing sufficient warnings of the potential side effects, including Pradaxa bleeding complications.

Federal Pradaxa claims are currently undergoing pretrial proceedings in the United States District Court for the Southern District of Illinois under the supervision of the honorable Judge David R. Herndon. The first trial is scheduled to commence in August 2014.