MedLink Neurology Podcast is delighted to feature selected episodes from BrainWaves, courtesy of James E Siegler MD, its originator and host. BrainWaves is an academic audio podcast whose mission is to educate medical providers through clinical cases and topical reviews in neurology, medicine, and the humanities. Episodes originally aired from 2016 to 2021.

Originally released: November 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 of using this drug?

This week on the program we launch into a two-part series focused on some of the events that follow major clinical trials. In part 1, we cover the three major classifications of FDA alerts for medical treatments using two 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 (now X) @brainwavesaudio for the latest updates to the podcast.

REFERENCES

Ballard C, Hanney ML, Theodoulou M, et al. The dementia antipsychotic withdrawal trial (DART-AD): long-term follow-up of a randomised placebo-controlled trial. Lancet Neurol 2009;8(2):151-7. PMID 19138567

Dorsey ER, Beck CA, Darwin K, et al. Natural history of Huntington disease. JAMA Neurol 2013;70(12):1520-30. PMID 24126537

Hubers AA, van Duijn E, Roos RA, et al. Suicidal ideation in a European Huntington's disease population. J Affect Disord 2013;151(1):248-58. PMID 23876196

Moore TJ, Singh S, Furberg CD. The FDA and new safety warnings. Arch Intern Med 2012;172(1):78-80. PMID 22232155

Rose RV, Kass JS. Prescribing antipsychotic medications to patients with dementia: boxed warnings and mitigation of legal liability. Continuum (Minneap Minn) 2019;25(1):254-9. PMID 30707196

Schneider LS, Dagerman KS, Insel P. Risk of death with atypical antipsychotic drug treatment for dementia: meta-analysis of randomized placebo-controlled trials. JAMA 2005;294(15):1934-43. PMID 16234500

Schultz JL, Killoran A, Nopoulos PC, Chabal CC, Moser DJ, Kamholz JA. Evaluating depression and suicidality in tetrabenazine users with Huntington disease. Neurology 2018;91(3):e202-7. PMID 29925548

Shen V, Clarence-Smith K, Hunter C, Jankovic J. Safety and efficacy of tetrabenazine and use of concomitant medications during long-term, open-label treatment of chorea associated with Huntington's an