Overview: A new study in the Circulation: Cardiovascular Quality and Outcomes journal suggests that Pradaxa® has not made significant impact on the treatment rates of atrial fibrillation. Although the drug has been rapidly adapted since it came onto the US market in 2010, data indicates that the drug is being used increasingly for off-label purposes.
- A new study finds that even though the use of Pradaxa® was increasing, the treatment rates for atrial fibrillation remain largely unchanged
- Pradaxa® is still mostly used for atrial fibrillation, but it is being increasingly prescribed for off-label uses such as blood clots
- Pradaxa® is associated with a risk of uncontrollable bleeding, a complication that has led to a number of personal injury lawsuits
Product: Pradaxa® (dabigatran)
Manufacturer: Boehringer Ingelheim Pharmaceuticals
Side Effects & Complications
- Cerebral hemorrhaging
- Gastrointestinal (GI) hemorrhaging
- All types of bleeds including the intraspinal, intraocular, intraarticular (joints), retroperitoneal or pericardial areas
Using the IMS Health National Disease and Therapeutic Index, researchers at the John Hopkins Bloomberg School of Public Health analyzed the clinical use of oral anticoagulants in the US between 2007 and 2011. Overall, the use of Pradaxa increased from 4 percent to 16.9 per cent while warfarin use has decreased from 55.8 percent to 44.4 percent.
Pradaxa visits jumped from 0.062M per quarter to 0.363M visits, upping its shares of oral anticoagulant visits from 3.1 percent to 18.9 percent. The proportion of its use for atrial fibrillation however, has dropped from 92 percent to 63 percent. Although Pradaxa is still mostly used for atrial fibrillation, this data indicates that it is being used more and more for off-label purposes. This is further supported by the fact that the proportion of atrial fibrillation patients not treated with anticoagulants remains largely unchanged, about 40 percent.
The authors concluded that the research “did not find evidence that it has increased overall atrial fibrillation treatment rates.”
The U.S. Food and Drug Administration (FDA) approved Pradaxa in October 2010 to prevent blood clot, stroke and heart attack in patients with atrial fibrillation. The drug gained clearance through an expedited approval process. According to recent report published in the Journal of the American Medical Association, the risks associated with Pradaxa and other medications approved this way raises the question of whether or not it is beneficial to approve drugs without adequate data to back its use.
Although Pradaxa is being applied as a warfarin replacement, its bleeding risks are a considerable drawback. Like all blood thinners, warfarin and Pradaxa carry a risk of hemorrhaging. Warfarin, however, has reversal agents to stop the bleeding while Pradaxa does not. This can have serious real-world implications, as minor trauma may lead to potentially fatal events.