Product News and Recalls

Pradaxa more dangerous than alternative

A study recently presented to the 2012 Thombosis and Hemostasis Summit of North America compared Pradaxa to Coumadin and found that Pradaxa has a higher risk of bleeding and other complications.

Manufacturer Boehringer Ingelheim Pharma markets Pradaxa as a preferable alternative to warfarin, because Pradaxa, despite these risks, doesn’t require frequent blood tests.

The two blood thinners are known by their chemical names warfarin, sold under brand name Coumadin, and dabigatran, sold under brand name Pradaxa. A number of previous studies have linked Pradaxa to heart attacks, internal bleeding, and other dangerous symptoms.

The study, called “Dabigatran in the Real World,” took place at a large anticoagulation clinic managing 2,200 patients on oral therapy. Starting in Nov., 2010, all clinic patients whose prescribing physicians requested a switch from warfarin to dabigatran were tracked for a year.

The study primarily looked for clinical events that would lead to the discontinuation of either medication, including blood clots, bleeding or treatment-related deaths. Researchers ended up with 113 patients who could be evaluated.

During the warfarin treatment period, there was one hospitalization following a diagnosis of warfarin toxicity.

During the dabigatran treatment period, however, reserchers recorded:

  • One treatment-related death from bleeding
  • Four other bleeding episodes
  • One blood clot in a deep vein
  • One blood clot in the heart
  • One transient ischemic attack, a brief episode in which the brain gets insufficient blood
  • One skin rash
  • Four incidents of gastrointestinal symptoms bad enough to require the dabigatran to be stopped.

Patients should consult their doctors before making any changes in their medication. A consultation with a Pradaxa lawyer is also important if there are significant injuries.