Study Reveals Pradaxa Bleeding Risk Increased with Some Statins

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Study Reveals Pradaxa Bleeding Risk Increased with Statins
Study Reveals Pradaxa Bleeding Risk Increased with Statins

A new Canadian study revealed that the popular blood thinner Pradaxa, when used with certain statins, may increase the risk for bleeding for patients dealing with atrial fibrillation (A Fib). A Fib is a condition characterized by an irregular heartbeat that may lead to blood clots increasing the risk of stroke.

According to the Canadian study, in Pradaxa users who are prescribed the statins Mayacor (lovastatin) or Zocor (simvastatin) for the control of LDL cholesterol, the combination may increase the danger for Pradaxa bleeding.

Personal injury attorneys at Parker Waichman LLP are actively reviewing potential lawsuits on behalf of individuals who have been injured by anticoagulant drugs.

Canadian Study Information

Researchers from St. Michael’s Hospital in Toronto examined data from 46,000 patients aged 65 and over, suffering from atrial fibrillation, reported Healthy Daily Digest (November 22, 2016). Tony Antoniou, PhD and colleagues noted, “Association between statin use and ischemic stroke or major hemorrhage in patients taking dabigatran or atrial fibrillation.” They determined that Pradaxa patients who also took Mevacor or Zocor for cholesterol control showed an increased risk for Pradaxa bleeding events over Pradaxa patients taking a different statin.

The study authors stated that the higher risk, translated to a 40 percent heightened risk for Pradaxa bleeding. Patients were at a greater risk for needing emergency treatment or being hospitalized.

Anticoagulant or Blood Thinner Data

Anticoagulants all carry a risk of bleeding, but there are differences in the various blood thinners. Coumadin (warfarin) has been on the market for over 50 years and has an available antidote should there be a medical emergency such as an accident or unplanned surgery. Coumadin requires strict blood test monitoring and some dietary restrictions.

Pradaxa, along with Xarelto and Eliquis, is one of the “new generation” anticoagulants that was rapidly embraced as more convenient, as it does not require the relatively strict monitoring that warfarin does. However, to date, there is no antidote, except for Pradaxa, in the case of excessive or uncontrollable bleeding events for those taking the newer blood thinners. In the Pradaxa lawsuits, it has been alleged that there is an increased risk for Pradaxa heart attacks and Pradaxa deaths.

Boehringer Ingelheim Pharmaceuticals, the manufacturer of Pradaxa, recently announced data from a new analysis of the GLORIA-AF Registry that shows newly-diagnosed patients suffering from non-valvular atrial fibrillation (NVAF). These patients, are treated with dabigatran Pradaxa presented with a 76.6 percent probability of staying on Pradaxa for 12 months, and a corresponding 69.2 percent probability for two years.

Jonathan Halperin, MD, of the Robert and Harriet Heilbrunn Professor of Medicine at the Icahn School of Medicine said, “Patients with NVAF are at a five times greater risk for stroke, and the goal of anticoagulant therapy is to reduce this risk. It is critical for patients and physicians to understand the benefits of staying on prescribed treatment and the potential risks of discontinuing.” Dr. Halperin and members of the GLORIA-AF steering committee said in a statement, “In general, nearly half of patients discontinue oral anticoagulant therapy after only a year, so it is promising to see high adherence rates with Pradaxa in this new analysis from the GLORIA-AF Registry.”

Legal Issues Involving Pradaxa

A woman filed a lawsuit alleging that her late husband suffered an uncontrollable brain hemorrhage triggered by Pradaxa. The fact that dabigatran Pradaxa was brought to market without any effective means to reverse the blood thinning effects of the drug, as maintained, there was little physicians could do once the brain hemorrhage had begun.

In another recent Pradaxa lawsuit, while prescribed Pradaxa to help manage stroke risk and systemic embolism linked to non-valvular atrial fibrillation, a patient suffered an uncontrollable Pradaxa bleeding event. As a result, the plaintiff, who survived, suffered various injuries that resulted in a loss of consortium claim on the part of his wife.

Study Reveals Pradaxa Bleeding Risk Increased with Statins
Study Reveals Pradaxa Bleeding Risk Increased with Statins

Unlike Xarelto or Eliquis, Pradaxa is the only novel oral anticoagulant to have a specific reversal agent. An available antidote does not, however, lessen the increased risk for Pradaxa bleeding in patients taking lovastatin or simvastatin, as noted by Canadian researchers.

The European Medicines Agency reported that some 50 to 256 deaths have been allegedly associated to Pradaxa side effects. In early December, The GLORIA-AF data was presented to the Annual Meeting of the American Society of Hematology in San Diego.

Legal Help for Pradaxa Users

If you or someone you know suffered uncontrollable bleeding involving the use of Pradaxa, you may have valuable legal rights. The attorneys at Parker Waichman offer free, no-obligation case evaluations. For more information, contact our personal injury lawyers at 1-800-YOURLAWYER (1-800-968-7529).