Improper dosing of anticoagulation can result in stroke, pulmonary embolism, bleeding, or death. Despite the great risk, a recent study published by the New England Journal of Medicine (NEJM) shows that underdosing and overdosing of newer blood thinner medications is rampant. The study focused on the use of novel direct acting oral anticoagulants (DOACs), such as Pradaxa, Xarelto, Savaysa and Eliquis, in people with atrial fibrillation (AF).
AF is a condition where the heart beats irregularly due to errant electrical pulses. When at extended rest, blood within the heart can become static (stasis) and form blood clots. The heart then beats forcefully, expelling the blot clot into the blood stream. A mobile blood clot is called an embolism. Embolisms can travel through the blood stream into the brain, where they can block the supply of blood and oxygen to the brain. Blockage, or occlusion, causes brain tissue to die. A “stroke” refers to the clinical effects of permanently damaged brain tissue, which include brain damage, cognitive impairment, motor dysfunction, loss of bowel and bladder control and paralysis.
The risk of stroke from AF is higher in some patient than others. Doctors should determine this risk by calculating the patient’s CHADS2 score, as well as consideration of other less common risk factors. The CHADS2 score is based on the fact that (C)ongestive heart failure, (H)ypertension, (A)ge over 75, (D)iabetes and prior (S)troke or TIA symptoms raise the risk of stroke in patients having AF. Anticoagulation is used to prevent clots from forming while the heart is at extended rest.
Older anticoagulation drugs such as Warfarin and Coumadin required that the patient have routine blood work done to ensure that the patient’s clotting times remained in the proper range. Too much anticoagulation and the patient is at risk of bleeding, including a brain bleed called a hemorrhagic stroke. Too little anticoagulation and the patient remains at risk of blood clots. The amount of anticoagulation required to keep the patient’s clotting times (INR) in the therapeutic range varies from patient-to-patient, and can be affected by diet and other medications. So frequent blood checks were necessary.
The newer class of anticoagulants, the NOACs, were designed to reduce the amount of blood work needed to safely monitor a patient. Theoretically, the hassle and discomfort of frequent blood draws led to noncompliance by patients, thereby putting them at unnecessary risk of an embolic stroke. As an Ohio stroke lawyer, I have monitored the approval process for NOACs. Notoriously corrupt pharmaceutical companies stand to make huge profits by capturing market share in the sale of anticoagulants. Several months ago, I warned that these drugs may not be ready for prime time, given my skepticism about the industry-influenced vetting process. Soon thereafter, a number of fatalities related to side effects were reported.
The NEJM study found that in 43% of patients with AF and poor kidney function, physicians failed to adjust the dose downward to account for drug retention. Those patients on certain DOACs faced an increased risk of a bleeding. 13% of patients with normal kidney function were inexplicably prescribed lower than normal doses. Underdose increases the risk of stroke fivefold when compared with the standard dose for patients on certain DOACs. When a physician fails to prescribe a proper dose of any medication, and severe injury results, they are subject to a medical malpractice lawsuit under Ohio law.
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