Bleeding Risk with Newer Blood Thinners Diminish Benefits: Study

The risk of bleeding with Pradaxa and other new-generation blood thinners may negate all of their potential health benefits, according to the findings of new research. 

In a report published on-line this week by The Archives of Internal Medicine, European researchers conducted a seven-study meta analysis of major bleeding events that occurred after the use of blood thinners, finding that medications known as xa inhibitors and direct thrombin inhibitors have a high enough rate of bleeding events to diminish the benefits provided by the medications.

The researchers looked at databases of studies conducted on patients who were given blood thinners after suffering acute coronary syndrome (ACS). They found placebo-controlled clinical trials that included more than 30,000 patients. They found triple the risk of bleeding events, but only moderate reductions in the risk of stent thrombosis or further heart problems and no significant effect on the survival of the patient.

“For the net clinical benefit, treatment with new-generation oral anticoagulant agents provided no advantage over placebo,” the researchers reported. “The use of anti-Xa or direct thrombin inhibitors is associated with a dramatic increase in major bleeding events, which might offset all ischemic benefits in patients receiving antiplatelet therapy after an ACS.”

The most popular of the class of direct thrombin inhibitors to date has been Pradaxa, a blood thinner by Boehringer Ingelheim. Released in October 2010, concerns quickly arose over the risk bleeding problems with Pradaxa, often resulting in death or catastrophic injury.

Pradaxa was heralded as a superior alternative to Coumadin (warfarin), because it is easier to use and requires less monitoring. However, the new breed of blood thinner has no available reversal agent to allow doctors to quickly counteract the blood thinning effects if a bleeding even develops, increasing the risk of serious injury or death caused by the uncontrolled hemorrhages. Boehringer Ingelheim officials have said they are currently working on finding a reversal agent for Pradaxa.

A growing number of Pradaxa lawsuits have been filed against the drug maker on behalf of people who have been severely injured or who lost loved ones due to the drug’s side effects.

While there are currently about 50 cases pending in the federal Pradaxa litigation, the number of lawsuit is expected to continue to grow. All federal Pradaxa cases have been centralized before Judge David R. Herndon in the Southern District of Illinois, for coordinated pretrial proceedings as part of an MDL, or multidistrict litigation.