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Bleeding Problems with Pradaxa and Xarelto Highlighted in New Report

With Pradaxa lawsuits on the rise, drug manufacturer Boehringer Ingelheim just suffered another public relations blow with a new report from the healthcare information company AdverseEvents. The company compared adverse events linked to three new anticoagulant drugs on the market today; finding Pradaxa and Xarelto fell far behind Eliquis in terms of safety.

Pradaxa bottleFindings disputed by Boehringer Ingelheim

Boeheringer Ingelheim and Xarelto manufacturer Johnson & Johnson are both disputing the report’s findings, stating the comparison of adverse events involving the three drugs is unfair, unscientific and unreliable. The manufacturing giants pointed out that their drugs have been prescribed to many more patients than Eliquis, due to their time on the market and their various uses. Since it was approved in 2010, Pradaxa has been prescribed to more than eight million patients, while Xarelto has seen more than 5.4 million prescriptions.

In contrast, newcomer Eliquis has been prescribed just 435,000 times, which could explain the smaller number of adverse events associated with the drug. All three of these anticoagulants have been touted as a safer, more convenient alternative to the older blood-thinning drug warfarin, sold under the commercial name Coumadin. The drugs were first approved to prevent stroke in patients with atrial fibrillation. Unlike Coumadin, new anticoagulants can be prescribed without special dietary restrictions and the need for ongoing medical monitoring.

Unfortunately, these three newer drugs also have a significant difference from warfarin that could be contributing to concerns over the number of adverse events reports. Patients who experienceinternal bleeding while on Coumadin, either from injury or surgery, may receive doses of vitamin K to reverse the blood-thinning effect of the drug and promote clotting. Pradaxa, Xarelto and Eliquis have no such antidote at this time, making it difficult for doctors to control bleeding in some patients.

Pradaxa bleeding risk

The Institute for Safe Medication Practices reported that Pradaxa has been associated with more adverse events during 2011 and 2012. The organization also attributed the high number of serious injuries and death with the fact that a smaller dosing amount is not available in the U.S. for high-risk patients, as it is in other countries. In addition, no blood test is required for patients before they are prescribed Pradaxa, in order to determine whether the patient is at higher risk for bleeding events while on the medication.

Despite concerns, as well as a growing number of lawsuits that allege internal bleeding with Pradaxa, Boehringer Ingelheim is moving forward with plans to have the drug approved for other indications. Recently, the FDA approved Pradaxa for treating deep vein thrombosis and pulmonary embolism. Boehringer also announced a new study to determine the drug’s effectiveness in treating patients who have previously suffered an embolic stroke of undetermined source, or ESUS.

In the meantime, injured Pradaxa users continue to file lawsuits against Boehringer Ingelheim, claiming the company did not provide adequate warning about the potential risks associated with their product. Many of those cases are now pending in multidistrict litigation in U.S. District Court for the Southern District of Illinois. The MDL was established in 2012 in order to streamline early trial proceedings for the growing litigation.

Pradaxa lawyers have alleged injuries include internal bleeding like gastrointestinal bleeding and brain hemorrhage. Some patients have died as a result of their injuries, leaving surviving family members to seek legal action on their behalf.

  1.  MedPage Today, Pradaxa, Xarelto, Eliquis: NOAC’s Reversal a Key?
  2. PM Live, Boehringer Unveils Large Study in Stroke Prevention,
  3. FDA, Pradaxa (Dabigatran Etexilate Mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events,
  4. U.S. District Court, Southern District of Illinois, MDL No. 2385,
  5. Institute for Safe Medication Practices, ISMP Points to Need for New Measures to Reduce Dabigatran (Pradaxa) Bleeding Risks,