Pradaxa Internal Bleeding Reports Lead to Call for Prescriber Education

A group of New Zealand researchers indicate that the growing number of reports involving internal bleeding with Pradaxa, a new blood thinner, highlights the need for better prescriber education and suggests that the medication could be safer if there were a reversal agent like there is with older blood thinners like warfarin. 

The researchers’ views are outlined in a letter published by the New England Journal of Medicine on March 1, amid increasing concerns among the medical community about the risk of internal bleeding and death from side effects of Pradaxa.

Pradaxa (dabigatran) is a newer blood thinner, which was introduced by Boehringer Ingelheim in October 2010 as a superior alternative to Coumadin (warfarin) for prevention of strokes among individuals with atrial fibrillations. However, there have been a staggering number of reports involving hemorrhages among users of the medication, including hundreds of deaths from Pradaxa.

In the letter, researchers indicate that they looked at 78 reported bleeding events linked to Pradaxa use. They found that about 25% occurred due to prescriber errors, such as prescribing Pradaxa to patients with severe kidney problems. The researchers also determined that stopping the bleeding events was made more difficult by the lack of a reversal agent.

Among users of the older, more widely-used blood thinner Coumadin, known generically as warfarin, bleeding events can be addressed by giving the patient a dose of Vitamin K. Although it has been promoted as a superior medication because it requires less monitoring, Pradaxa internal bleeding problems can not be reversed if they do occur.

“We are concerned that the potential risks of this medication are not generally appreciated,” the researchers wrote. “The serious consequences of the lack of an effective reversal agent should not be underestimated.”

According to a report released by the Institute for Safe Medication Practices in January 2012, more instances of hemorrhages with Pradaxa were reported to the FDA’s Adverse Event Reporting System during the first quarter of 2011 than were reported in association with any other drug monitored by the group.  At least 505 instances involving Pradaxa bleeding events were reported, compared to 176 cases reported with warfarin/Coumadin, which was second on the list.

A number of individuals throughout the United States are now considering a Pradaxa lawsuit against the drug maker for failing to adequately research the medication or warning about the risk of serious and potentially life-threatening health risks of Pradaxa.