Bleeding side effects in patients treated with dabigatran (Pradaxa) have led a group of New Zealand hematologists to sound the alarm and call for better prescriber education.
The hematologists wrote of their concerns in a letter published in the March 1 issue of the New England Journal of Medicine. In a two-month review, they identified 78 bleeding episodes, including 12 major bleeds, one of which might have contributed to a patient's death,
Many of the bleeding incidents involved older patients and patients with reduced kidney function. Importantly prescriber error occurred in about 25% of the complications, revealing a lack of awareness of the potential risks associated with the drug.
The researchers reported that,"bleeding is an expected complication of dabigatran, especially in the elderly, a risk that is not completely mitigated by a dose reduction: 22 of our patients had a bleeding episode while receiving a reduced dose."
In reviewing the clinical characteristics of their 44 patients, the authors noted that two-thirds were older than 80, a majority had moderate or severe renal impairment, and half had low body weight (<60 kg).
The patients differed substantially from those in the pivotal trial of dabigatran, whose study population had a median age of 71, median weight of 83 kg, and creatinine clearance that averaged 68 mL/min.
The authors noted that "our audit illustrates the difficulty in extrapolating trial data into clinical practice and emphasizes the need for post-marketing surveillance and adverse-event reporting to detect groups whose risk factors may not be apparent in a clinical-trial setting."
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.