Nov 14, 2019
The FDA label for ACTEMRA (tocilizumab)--the first medication
approved for use in giant cell arteritis in 2017--is 40 pages long.
Of the information provided in this document, which includes
important dosing information, dose adjustments based on leukocyte
count, clinical trial and epidemiologic data, there is a box of
text on the first page of the insert. "WARNING: RISK OF SERIOUS
INFECTIONS" it reads.
What do you make of this warning? And with such a clear and
broad-sweeping statement stamped on the medication, how do you
mitigate the medico-legal risk for using this drug?
This week on the program we launch into a 2-part series focused
on some of the events which follow major clinical trials. In part
1, we cover the 3 major classifications of FDA alerts for medical
treatments using 2 examples from the neurologic pharmacopoeia. In
part 2, we emphasize the importance of post-publication peer
review. And both are equally instrumental in our medical decision
Produced by James E. Siegler with the support of Michael
Rubenstein (University of Pennsylvania) and Zachary Newcomer
(University of Florida). Music courtesy of Coldnoise, Cuicuitte,
Doctor Turtle, Jahzzar, and Peter Rudenko under a CC license. Sound
effects by Mike Koenig and Daniel Simion. BrainWaves' podcasts and
online content are intended for medical education only and should
not be used for clinical decision making. None of what is discussed
here should be misconstrued as medical advice, so don't just go
prescribing drugs off-label! (Or willy nilly, as my grandmother
might say) Be sure to follow us on Twitter @brainwavesaudio for the
latest updates to the podcast.
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