FDA finds no extra bleeding risk from dabigatran

NEWS IN BRIEF — Posted Nov. 19, 2012

Print  |   Email  |   Respond  |   Reprints  |   Like Facebook  |   Share Twitter  |   Tweet Linkedin

The Food and Drug Administration affirmed in November that dabigatran, an anticoagulant marketed as Pradaxa by Boehringer Ingelheim, does not pose a higher bleeding risk for patients compared with those who start treatment with warfarin.

The FDA’s assessment of the postmarket safety of dabigatran, a blood thinner used to cut the stroke risk for patients with atrial fibrillation, was done by analyzing insurance and claims data for reports of gastrointestinal and intracranial hemorrhages. The investigation was started after the FDA “received a large number of postmarketing reports of bleeding among Pradaxa users,” according to the agency’s safety announcement (link).

The FDA said it will not change its recommendations regarding dabigatran as a result of the analysis. Tens of thousands of patients are hospitalized annually due to hemorrhaging caused by blood thinners and careful management of these medications should be a patient safety priority, said the Centers for Disease Control and Prevention.

Note: This item originally appeared at

Back to top



Read story

Confronting bias against obese patients

Medical educators are starting to raise awareness about how weight-related stigma can impair patient-physician communication and the treatment of obesity. Read story

Read story


American Medical News is ceasing publication after 55 years of serving physicians by keeping them informed of their rapidly changing profession. Read story

Read story

Policing medical practice employees after work

Doctors can try to regulate staff actions outside the office, but they must watch what they try to stamp out and how they do it. Read story

Read story

Diabetes prevention: Set on a course for lifestyle change

The YMCA's evidence-based program is helping prediabetic patients eat right, get active and lose weight. Read story

Read story

Medicaid's muddled preventive care picture

The health system reform law promises no-cost coverage of a lengthy list of screenings and other prevention services, but some beneficiaries still might miss out. Read story

Read story

How to get tax breaks for your medical practice

Federal, state and local governments offer doctors incentives because practices are recognized as economic engines. But physicians must know how and where to find them. Read story

Read story

Advance pay ACOs: A down payment on Medicare's future

Accountable care organizations that pay doctors up-front bring practice improvements, but it's unclear yet if program actuaries will see a return on investment. Read story

Read story

Physician liability: Your team, your legal risk

When health care team members drop the ball, it's often doctors who end up in court. How can physicians improve such care and avoid risks? Read story

  • Stay informed
  • Twitter
  • Facebook
  • RSS
  • LinkedIn