Unintended consequences of antidepressant black box warning?

An article by Charles Nemeroff and colleagues in the Archives of General Psychiatry this month reports reports on the "Impact of Publicity Concerning Pediatric Suicidality Data on Physician Practice Patterns in the United States." (If you don't have access to the journal, you can read a report on the article here.)   The authors show that antidepressant prescription rates for children and adolescents have declined and there has been a shift in proscriber patterns from "generalists" (PCPs) to "specialists" (generally psychiatrists) since the FDA placed a black box warning related to suicide risk.  The warning includes the following statement: "Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders."  You can read the entire warning in a .pdf here).

The study does not study who is not getting medication that might have in the past--just that fewer kids are getting the medicine.  Whether that is ultimately good or bad remains to be seen.

Kelly Posner, who headed the FDA/Columbia Reclassification study, spoke at our Department Grand Rounds last month and lead a seminar with a smaller group of us about the reclassification scheme.  (The reclassification project looked in detail at reported adverse events that started this controversy.)   She clearly thought the consequences of the warning would be mostly negative.   She shared her concern (which has been stated by others as well) that the unintended consequence of the black box warning will be fewer youth treated for depression and more deaths by suicide, as a result.  From what I have read, that remains an empirical question and one that will require careful interpretation of data before inferring causality. What is clear is that the black box warning was probably based more on political and emotional concerns than on science (see also Marshall, Posner, and Greenhill, 2006), and that the risk of untreated depression is probably greater than the risk of adverse events from treatment.

[mounting soapbox]  That said...when this discussion comes up I think it is important to add psychotherapy and counseling to the landscape.  Untreated depression can be deadly, but that doesn't mean the treatment has to be medication.  [coming down off soapbox]

What are the implications for risk assessment?   I'm still trying to understand that.  How I am guiding our clinicians at this point is this:   When conducting a risk assessment of an adolescent or young adult in the first weeks following initiation of antidepressants, we need to note that antidepressants have been recently started.  But rather than name this as a "risk factor" we would do better to note how the medication response will be monitored and indicate the risk-related symptoms that are being targeted by the medication.  That is, connect the medication to the risk factors it is designed to reduce, more than to the risk it might carry.

References




  1. Marshall, R. D., Posner, K., & Greenhill, L. (2006). Risk Perception Research and the Black Box Warning for SSRIs in Children. Journal of the American Academy of Child & Adolescent Psychiatry, 45(7), 765.

  2.  Nemeroff, C.B. et al. (2007. Impact of Publicity Concerning Pediatric Suicidality Data on Physician Practice Patterns in the United States.  Archives of General Psychiatry, 64:466-472.