"Our review of unselected cases has limitations but highlights the need for appropriate prescriber education. In all patients, especially those 80 years of age or older with impaired renal function or low body weight, there must be a careful evaluation of the risks and benefits of treatment before starting dabigatran." When contacted for comment by MedPage Today, a spokesperson for drugmaker Boehringer-Ingelheim referenced dabigatran's prescribing information, which states that the pivotal clinical trial "showed a trend toward a higher risk of major bleeding with Pradaxa 150 mg compared to warfarin in patients age 75 or older. The risk of stroke and bleeding increases with age, but the risk-benefit profile with Pradaxa 150 mg is favorable in all age groups. "In recent months, we have provided physicians with additional guidance on the appropriate use of Pradaxa, including formal recommendations to conduct renal function testing prior to initiation of therapy and periodically as clinically indicated. “Global data collected to date on major bleeding are consistent with our expectations based on the [pivotal] trial and are in alignment with the U.S. PI, which clearly state the benefits and risks associated with Pradaxa. Overall, the positive benefit-risk ratio of Pradaxa in nonvalvular atrial fibrillation remains unchanged.” ### From the American Heart Association: 2011 ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Update on Dabigatran) Primary source: New England Journal of Medicine Source reference: Harper P, et al “Bleeding risk with dabigatran in the frail elderly” N Engl J Med 2012; 366: 864-866.