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 making.

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.

REFERENCES

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