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BrainWaves: A Neurology Podcast

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 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.


  1. Schneider LS, Dagerman KS and Insel P. Risk of death with atypical antipsychotic drug treatment for dementia: meta-analysis of randomized placebo-controlled trials. JAMA : the journal of the American Medical Association. 2005;294:1934-43.
  2. Ballard C, Hanney ML, Theodoulou M, Douglas S, McShane R, Kossakowski K, Gill R, Juszczak E, Yu LM, Jacoby R and investigators D-A. The dementia antipsychotic withdrawal trial (DART-AD): long-term follow-up of a randomised placebo-controlled trial. The Lancet Neurology. 2009;8:151-7.
  3. Moore TJ, Singh S and Furberg CD. The FDA and new safety warnings. Archives of internal medicine. 2012;172:78-80.
  4. Dorsey ER, Beck CA, Darwin K, Nichols P, Brocht AF, Biglan KM, Shoulson I and Huntington Study Group CI. Natural history of Huntington disease. JAMA Neurol. 2013;70:1520-30.
  5. Hubers AA, van Duijn E, Roos RA, Craufurd D, Rickards H, Bernhard Landwehrmeyer G, van der Mast RC, Giltay EJ and Network RiotEHsD. Suicidal ideation in a European Huntington's disease population. J Affect Disord. 2013;151:248-58.
  6. Shen V, Clarence-Smith K, Hunter C and Jankovic J. Safety and Efficacy of Tetrabenazine and Use of Concomitant Medications During Long-Term, Open-Label Treatment of Chorea Associated with Huntington's and Other Diseases. Tremor Other Hyperkinet Mov (N Y). 2013;3.
  7. Schultz JL, Killoran A, Nopoulos PC, Chabal CC, Moser DJ and Kamholz JA. Evaluating depression and suicidality in tetrabenazine users with Huntington disease. Neurology. 2018;91:e202-e207.
  8. Rose RV and Kass JS. Prescribing Antipsychotic Medications to Patients With Dementia: Boxed Warnings and Mitigation of Legal Liability. Continuum (Minneap Minn). 2019;25:254-259.
  9. US Food and Drug Administration. Guidance for industry: warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products—content and format. Published October 2011. Accessed 11 July 2019.