Brainwaves

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