Despite Lack of Benefit and Increased Suicidality, FDA Approved Lexapro for Seven-Year-Olds

A new paper investigates the evidence used by the FDA in its controversial 2023 expansion of escitalopram for young kids with anxiety.

3
2847

In 2023, the FDA expanded the approval of the antidepressant escitalopram (Lexapro) in a controversial move to treat anxiety in children as young as seven years old.

Now, in an article posted before peer review on Google Drive, researcher Martin Plöderl at Paracelsus Medical University in Austria has done a thorough review of the evidence base used by the FDA to come to this decision.

“The efficacy of escitalopram for pediatric GAD is likely not clinically meaningful and the increased occurrence of suicidal ideation and other adverse events with escitalopram . . . suggests that the drug conveys significant harms,” Plöderl writes.

While the authors of the pivotal clinical trial wrote, “Escitalopram reduced anxiety symptoms and was well tolerated,” and the FDA wrote, “the benefits of the product outweigh the risks,” Plöderl notes that the response and remission rates were not statistically significantly different between the placebo and drug groups. Indeed, in terms of remission, the placebo group had slightly more children doing better (although this difference was not statistically significant).

Worse, in the trial, 1.5% of children taking placebo became suicidal, compared with 9.5% of children on escitalopram.

Given the demonstrated lack of efficacy and the increased suicidality, how did the FDA justify moving forward with expanding the approval of this drug in children?

You've landed on a MIA journalism article that is funded by MIA supporters. To read the full article, sign up as a MIA Supporter. All active donors get full access to all MIA content, and free passes to all Mad in America events.

Current MIA supporters can log in below.(If you can't afford to support MIA in this way, email us at [email protected] and we will provide you with access to all donor-supported content.)

Donate

 

3 COMMENTS

  1. Thank you for the honest reporting, Peter. Let’s hope and pray we may some day end the massive abuse of children, and adults, by big Pharma and the scientifically “invalid” psychiatric and psychological industries. It’s truly disgusting.

    Stop abusing innocent children for profit, psychological and psychiatric industries, FDA, et al.

    Report comment

  2. Please read as a Tell it like it is note
    In the unit recently due to being a healthy vermin without a terminal problem and put on ability injections after refusing a second blood test collect. Was punched day after my admission. Spent time in max security with 2 males no loks on either toilet or on shower. Now I bungle my thinking into action. After 40 years I am putting my survival first. My only idea of being seen as the best example is to tell them to step outside to find out my new nickname is/isn’t Punch Punch
    I am a bodyguard. I do bouncing. Punch Punch. Don’t mess with me. I am 61 going on 18. No rules means you asking for it.

    Report comment

LEAVE A REPLY