Amid Bleeding Concerns, Pradaxa Approval Expanded for New Indication

Federal drug regulators have expanded the approved uses of the blood thinner Pradaxa, despite continuing safety concerns involving the risk of uncontrollable bleeding events, which have made the anticoagulant one of the most frequently cited drugs in adverse event reports submitted to the FDA.  

On April 7, the drug maker Boehringer Ingelheim announced that the FDA has approved Pradaxa for the treatment of deep vein thrombosis and pulmonary embolism.

The approval only applies to patients who have been treated with a parenteral anticoagulant for five to 10 days. It is also approved to reduce the risk of these blood clot disorders among patients who have been previously treated and in whom the conditions may recur.

Deep vein thrombosis and pulmonary embolism are known as venous thromboembolisms, and are the side effects of blood clots. It is the third most common form of cardiovascular disease.

Boehringer Ingelheim says the FDA’s approval was based off the performance of the drug in clinical trials, which showed the drug was about as effective as warfarin, an older blood thinner also sold under the brand name Coumadin.

Pradadxa (dabigatran) is a relatively new anticoagulant therapy that was introduced by Boehringer Ingelheim for stroke prevention in 2010. The medication was the first member of a new class of drugs that are promoted as superior alternatives to warfarin, because they are easier to use and require less monitoring.

Shortly after Pradaxa was approved, the medication began to rack up a record number of adverse event reports submitted by doctors and patients, often involving incidents of uncontrolled bleeding or hemorrhages linked to Pradaxa side effects.

The drug has come under scrutiny because, unlike warfarin, it does not currently have an approved reversal agent that can be used by doctors to quickly stop its blood thinning effects. Patients who suffer bleeding events on warfarin can be given vitamin K to stop the drug’s effects, but no such antidote exists for Pradaxa. Some doctors say that lack of a reversal agent has led to bleeding injuries and death.

There have been thousands of reports of injuries and hundreds of deaths associated with Pradaxa use since it was introduced in October 2010.

Boehringer Ingelheim currently faces more than 2,000 Pradaxa bleeding lawsuits brought on behalf of individuals throughout the United States who allege that the drug maker failed to adequately warn about the risks associated with the anticoagulant and the lack of an effective reversal agent.

All federal complaints have been centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois for coordinated handling as part of an MDL, or multidistrict litigation. The first Pradaxa trials are expected to begin later this year, with a series of four “bellwether” cases set to go before juries between September 2014 and March 2015.