No, the FDA’s Black Box Warning Did not Increase Suicides

Researchers again debunk the claim that the FDA black box warnings on antidepressants led to more suicides.

Peter Simons
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There’s a substantial body of research that finds taking antidepressant drugs increases the risk of suicide, particularly in children and adolescents (even as much as double the risk). However, a 2020 article by Lu et al. made the opposite case, suggesting that the FDA’s black box warning led to decreased treatment and increased suicides.

But now, in a letter to the editor, researchers Glen Spielmans and Peter Parry debunk those claims yet again.

“The evidence does not support Lu et al.‘s contention that regulatory warnings led to decreased treatment, which then led to increased suicides,” they write.

Before putting a black box warning on the label for antidepressant drugs, the FDA commissioned an independent review by suicide experts from Columbia who were blinded to the groups so that their review would be unbiased. Those experts found that antidepressants increased the risk of suicide by 71% and the risk of aggression by 79%.

Studies have consistently found that the drugs are associated with increased suicide risk. For instance, a study from this year found that antidepressant use has increased in Australia, and suicide rates increased right along with it.

Other studies found similar results. The black box warning did decrease antidepressant treatment for about three years—and suicide rates decreased too. But then antidepressant use increased again—and so did suicide rates.

So how did Lu et al. come to the opposite conclusion? According to Spielmans and Parry, Lu et al. “found a decrease in antidepressant treatment of less than one percentage point among children and adolescents from 2000 to 2010,” and other research demonstrated that among youth with severe symptoms, antidepressant treatment didn’t decrease at all over that time.

Spielmans and Parry argue that uncontrolled studies like Lu et al.’s are not the best way to determine if antidepressants are linked to suicide risk—that would be the original randomized, placebo-controlled trials (RCTs), which the Columbia researchers analyzed at the FDA’s request, and which led directly to the black box warning.

In their response, Lu et al. write that Spielmans and Parry “demonstrate a lack of familiarity with rigorous quasi‐experimental research designs” because they suggested that RCTs were more robust than Lu et al.’s uncontrolled study.

Lu et al. conducted what’s known as an interrupted time-series study. According to researcher Marc Stone at the FDA, this type of study is “intuitively appealing but, in most cases, it is based upon false analogies, fallacious assumptions, and analytical errors.”

Lu et al. also argue that Spielmans and Parry were wrong to compare the actual use of antidepressants before and after the FDA black box warning. They write that if one assumes that antidepressant prescriptions would have continued to increase substantially every year, then the fact that they leveled off and remained steady should count as a huge decrease.

The type of reasoning exhibited by Lu et al. here may be best described again by Marc Stone:

“Instead of designing studies that test falsifiable hypotheses, these investigators adopt methods and data sources that serve as little more than descriptions of these beliefs in the guise of analysis.”

 

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Spielmans, G. I. & Parry, P. (2021). Black box warning did not cause increased suicides. Psychiatric Research and Clinical Practice. First published: 26 February 2021. https://doi.org/10.1176/appi.prcp.20200038 (Link)

8 COMMENTS

  1. I’ve been thinking about this further and I wonder if the results of 2020 are going to confound the link between antidepressant prescriptions and suicide. It appears that suicides went down among almost all demographics in 2020, but it also appears that AD and other psychotropic prescribing increased substantially. So this will lead to questions about what other social factors independently influence suicide trends, such as stay at home orders.

    There are other trends that are increasing as well as we ease back into normal routines like work and school and indoor shopping and dining including mass shootings, robberies, and other violent and interpersonal crimes, which had largely decreased during the isolation, with a few exceptions such as domestic violence.

    Reading the tea leaves here, it seems that we traded one set of stressors for another. I wonder if the increase in AD prescribing rates in 2020 was more attributable to the drastic unexpected change of lifestyle that might have evened out the longer people had to get used to such. And if the increase in violent crime since the lockdowns have been lifted is evidence of increased social stress generally.

    I have to wonder then if 2021 is going to see a big jump in suicide rates with the return to prepandemic lifestyles combined with the increased AD prescription rate, especially as folks tend to continue psychotropic use long term so they will now be dealing with the abnormal stressors of our “normal” routines combined with their psychiatric drugs. It will be interesting to see how the next few years data plays out.

      • I think the timeline and demographics may shed more light on that.

        It appears that in places where there were strict lockdowns like the west coast and northeast, crime went down during the lockdown period and gradually began to rise in concert with the lifting of the restrictions. However, South Carolina, which didn’t have much in the way of lockdowns in comparison to those other parts of the country saw it’s biggest rise in violent crime on record apparently during 2020. So it seems plausible that there is a connection with lockdown itself, perhaps simply in terms of fewer opportunities to commit crimes of opportunity.

        As for the drugs, the suicide attempt numbers for teen girls rose significantly (50%) and it appears to coincide with the increase in antidepressant prescribing during 2020. Not that any of the mainstream media articles mention that as a possible factor.

    • Personally, I believe we’re all being deluded with massive numbers of lies, and living in an upside down and backwards America.

      But, then again, I painted that as our reality, 16 years ago.

      Thanks, Peter, for pointing out the psychiatric industries’ systemic lies.

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