Despite Bleeding Problems and Lawsuits, Pradaxa Sales Hit $1.43B

Despite reports of uncontrolled hemorrhages and a growing number of Pradaxa lawsuits filed over the manufacturer’s failure to adequately warn about the lack of a reversal agent to stop bleeding problems that may develop, Boehringner Ingelheim’s new anticoagulant has achieved blockbuster status in the second full year on the market.  

Sales of Pradaxa reached $1.43 billion last year, according to the drug company, placing it among the best selling medications in the world.

Any drug that achieves $1 billion in annual sales is considered to be a blockbuster product, even if it has been associated with an alarming number of adverse event reports including serious injuries and deaths.

While the medication has quickly been adopted by the medical community as an alternative to warfarin or Coumadin, which has been the go-to medication for stroke prevention among individuals with atrial fibrillation for decades, Pradaxa has been linked to thousands of reports involving uncontrollable bleeding and death.

Pradaxa Bleeding Problems

Pradaxa (dabigatran) was the first member of a  new class of blood thinner drugs, which was introduced in October 2010. The drug has been aggressively marketed by Boehringer Ingelheim as superior to warfarin because it requires less monitoring.

Unlike warfarin, which has a reversal agent that can be used to stop bleeding problems, Pradaxa has no antidote and doctors are often unable to reverse the blood thinning effects of the medication if a user develops a hemorrhage.

During the first full year the drug was on the market in the United States, the Institute for Safe Medication Practices (ISMP) found that adverse event reports involving problems with Pradaxa surpassed all other medications regularly monitored by the group. FDA received at least 3,781 reports involving serious injuries associated with the use of Pradaxa during 2011, including 2,367 reports of hemorrhage and 542 patient deaths.

Despite the problems, Pradaxa pushed Boehringer Ingelheim’s drug sales up 11.5%. However, the company’s total income dropped 18% due to ongoing drug trial expenses and upgrades it was forced to make o its Bedford, Ohio manufacturing facility. The FDA forced the plant to shut down earlier this year as part of a consent decree that will keep it closed until the facility complies with FDA standards.

Pradaxa Bleeding Lawsuits Continue to Mount

Boehringer Ingelheim currently faces several hundred product liability lawsuits alleging that inadequate warnings were provided about the risk of bleeding problems with Pradaxa.

In the federal court system, the Pradaxa litigation is centralized before U.S. District Judge David R. Herndon as part of an MDL, or multidistrict litigation.

According to a case management plan issued by the court, a handful of cases are being prepared for early trial dates, which are expected to go to trial in August 2014.  Judge Herndon has also ordered the parties to meet every month starting in August 2013, to discuss potential Pradaxa settlement agreements.