Pradaxa Complication Rates Higher Than Coumadin: Preliminary Results

According to the preliminary results from an on-going study, the blood thinner Coumadin (warfarin) may be safer than newer drugs like Pradaxa, which has been linked to a number of deaths and other complications from uncontrollable bleeding. 

At the 2012 Thrombosis and Hemotasis Summit of North America last week, researchers from Alere, Inc. announced preliminary findings of a study looking at the safety of new blood thinners. They found that patients have to be removed from Pradaxa treatment due to complications more often than patients need to be removed from warfarin treatment, with the Pradaxa complications often occurring very early in the treatment.

Coumadin, which is known generically as warfarin, is an older blood thinner prescribed to reduce the risk of strokes and blood clots in certain high-risk patients. In recent years, there have been increasing efforts to identify alternative therapies, as warfarin requires extensive patient monitoring.

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Pradaxa (dabigatran) is the first drug in a new class of anticoagulants, which was introduced in October 2010. Although Pradaxa has been promoted as a superior alternative to Coumadin because it requires less monitoring, increasing concerns have emerged about the risk of severe bleeding events and other complications on Pradaxa.

In the preliminary findings of the Alere, Inc. study, researchers looked at 2,200 patients on oral blood thinner therapy. The rate of complications among warfarin patients was 0.88%. The rate of complications experienced by Pradaxa patients was 11.5%.

During the study, only one patient on warfarin was hospitalized due to warfarin toxicity. By comparison, Pradaxa complications included one death from gastrointestinal bleeding, four other bleeding events, an incident of deep vein thrombosis, a heart attack, a case of atrial thrombus, a skin rash and four cases of gastrointestinal problems so severe that the patients were taken off the drug.

Amid a growing number of post-marketing reports involving deaths and other bleeding problems linked to side effects of Pradaxa, the FDA announced in December 2011 that it was reviewing the safety of the new blood thinner.

According to a report released by the Institute for Safe Medication Practices in January 2012, more instances of bleeding problems with Pradaxa were reported to the FDA 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, which was second on the list.

In recent months, a growing number of Pradaxa lawsuits have been filed in state and federal courts throughout the United States in recent months.  The complaints allege that Boehringer Ingelheim failed to adequately research their medication and or warn that severe bleeding complications that occur with Pradaxa can not be reversed like they can be with warfarin or Coumadin.


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