NSF: don’t stop AF meds
August 5, 2014
THE National Stroke Foundation
(NSF) is urging people not to stop
taking their atrial fibrillation (AF)
or irregular heartbeat medication
without consulting a doctor.
This follows a report by the
British Medical Journal which said
makers of the oral anticoagulant
dabigatran, Boehringer
Ingelheim (BI), did not share with
regulators information about the
potential benefits of monitoring
anticoagulant activity and adjusting
dose to make sure the drug was
working as safely and effectively
as possible, as well as analyses
calculating how many major bleeds
dose adjustment could prevent.
BI said these statements were
“misleading”, saying that in 2012,
researchers performed exploratory
simulations with mathematical
models to understand whether
dose adjustments based on plasma
concentrations might improve
the efficacy and safety profile of
Pradaxa (dabigatran etexilate).
“The initial hypothesis from this
mathematical model could not be
supported when applied to the
actual clinical data from the RE-LY
population.
“Therefore, they were not
provided to regulators.”
Dosing decisions based solely on
blood levels was not supported by
evidence, BI said, with individual
characteristics such as age “critical
factors” in contributing to the risk
of bleeding.
NSF clinical council chair Professor
Richard Lindley said people should
not stop taking their prescribed
AF medication as they might be at
risk of stroke if they did so without
medical advice.
“For people with atrial fibrillation,
taking a suitable anticoagulant may
be a vital part of reducing their
stroke risk.’’
To read the BMJ report, CLICK
HERE and to read BI’s response,
CLICK HERE.
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