Dabigatran, sold under the commercial brand name Pradaxa, has been considered to be a miracle cure when it comes to preventing stroke. It is an alternative to warfarin (sold as Coumadin, Jantoven and other brand names), which has numerous side effects ranging from hemorrhaging and osteoporosis to gangrene as well as heparin, which also has a number of adverse effects including elevated blood pressure and heart rate with accompanying chest pains.
But there are also Dabigatran side effects as well, and these have raised serious concerns in the medical community. According to a recent study published in a major medical journal, patients undergoing anticoagulant therapy with dabigitran run a significantly higher risk of heart attacks.
That's not all. While all anticoagulant medications can cause hemorrhaging (excessive bleeding), patients being treated with dabigatran appeared to have fewer episodes – but those episodes were more serious. This has raised some concerns in New Zealand, where the drug has been available and widely prescribed since July of 2011. Over the subsequent seven-month period, about 7000 patients began treatment with dabigatran.
Dabigatran side effects were seen quickly. In the first two months, doctors identified almost 80 cases in which patients suffered a hemorrhage, twelve of which were serious – and one in which the patient died. These patients were primarily elderly, and/or had impaired kidney function. However, these doctors said that about a quarter of the cases in which patients experienced excessive bleeding were due to “prescriber error.”
Excessive bleeding is an acknowledged risk when it comes to all types of “blood thinners” (this description is not entirely accurate; these medications inhibit blood clotting, they do not actually thin the blood). The New Zealand doctors who spoke out in a letter to the New England Journal of Medicine expressed their concerns that prescribers were not sufficiently knowledgeable about the risks and “real-world” implications of dabigatran side effects. In other words, there is a difference between clinical data in the research lab and what happens when actual patients are treated in practice. The doctors are calling for greater “post-marketing surveillance and adverse-event reporting to detect groups whose risk factors may not be apparent in a clinical-trial setting.”
Harper, Paul M.D. et. al. “Bleeding Risk With Dabigitran in the Frail Elderly.” New England Journal of Medicine, 1 March 2011.
Uchino, Ken and Adrian Hernandez. “Dabigatran Association With Higher Risk of Acute Coronary Events.” Archives of Internal Medicine, vol. 172 no. 5 (12 March 2012).
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