Clinical relevance: Half a dozen psychiatric groups, including the APA, called out a new presidential commission questioning psychotropic medications.

  • The groups stressed the proven safety and efficacy of these medications through extensive research and FDA oversight.
  • Concerns were raised about misinformation potentially deterring patients from seeking mental health care.
  • Researchers highlighted unintended consequences of FDA black-box warnings, linking them to reduced mental health treatment and increased suicide rates.

Half a dozen psychiatric groups have pushed back on a presidential administration that appears to be (unfairly) targeting psychotropics.

In a statement published this week, the American Psychiatric Association (APA) – and others – declared that “The safety and efficacy of traditional antidepressants, antipsychotics, and mood stabilizers (such as lithium and some anticonvulsants) and stimulant medications have been established through decades of rigorous research, randomized clinical trials, peer-reviewed studies, meta-analyses, national registry studies of thousands of people, post-marketing pharmacovigilance monitoring, and FDA oversight.”

The statement arrives in the wake of the Trump Administration’s establishment of the Make America Healthy Again Commission through Executive Order 14212, which is tasked with (among other things) “assessing the prevalence of and threat posed by the prescription of selective serotonin reuptake inhibitors (SSRIs), antipsychotics, mood stabilizers, stimulants, and weight-loss drugs.”

“This groundbreaking commission will be charged with investigating what is causing the decades-long increase in chronic illness, reporting its findings and delivering an action plan to the American people,” President Trump added from the Oval Office shortly after signing off on the executive order.

The Journal of Clinical Psychiatry published the full statement here.

Open Skepticism of Psychotropics

The head of this new commission, U.S. Sec. of Health and Human Services Robert F. Kennedy, has been open in his criticism of some psychiatric medications.

“I know people, including members of my family, who’ve had a much worse time getting off SSRIs than people have getting off heroin,” he declared during his Senate confirmation hearing.

The APA statement tackles the misleading implication of that claim head-on.

“Inaccurate information about the safety and efficacy of FDA-approved psychotropic medications has been amplified by misleading statements that antidepressants are addictive and pose hazards comparable to Schedule I narcotics,” the trade groups added. “Like any medical treatment, psychotropic medications require monitoring. When used appropriately, these medications can stabilize serious mental illness, reduce suffering, shorten periods of disability, and save lives. Physicians work closely with patients and families to assess the risks and benefits of psychopharmacology and monitor for potential side effects, ensuring each patient receives individualized care.”

The White House doubled down on the skepticism shortly after President Trump signed the executive order when deputy press secretary Kush Desai insisted (as reported by NBC News) that “Americans have lost confidence in the medical apparatus that let us down during the COVID pandemic and oversaw an unprecedented explosion in chronic disease.” 

The Pitfalls of Misinformation

The associations followed up with a warning about misinformation – and the dangers it poses.

“Statistics on youth suicide further underscore the dangers associated with false information about safe treatments,” the group statement added. “Following the FDA’s 2004 boxed warning highlighting the risk for suicidal behavior in younger depressed patients taking serotonin reuptake inhibitors, suicide rates increased, by as much as 60% in untreated youth with major depression. Further, post-mortem toxicology studies suggest that many suicide victims with known mental health conditions do not have detectable levels of psychotropic medications in their system, further pointing to the hazard of undertreatment as a modifiable risk factor.

A Health Affairs review – published in 2024 – offered a further indictment of the still relatively new warning labels. The systematic review revealed “unintended consequences” of the FDA’s antidepressant black-box warnings.

Regulators originally demanded these warnings in 2005, before ordering an expansion in 2007.

While regulators meant for the warnings to promote vigilance, the data shows a distinct lack of evidence of improved monitoring. On the contrary, researchers noticed dramatic drops in doctor visits for depression, depression diagnoses, psychotherapy, and antidepressant use. The data exposed links between elevated rates of child psychotropic drug poisonings and suicide deaths.

The authors of the review argue that the warnings might have inadvertently scared some from getting mental health care. It’s little wonder, then, that researchers are calling for the FDA to reconsider its black-box warning approach. Insteast, they’ve offered alternative labeling strategies that could reduce harm while still keeping the consumers informed.

‘Psychotropics Are Safe’

“Psychiatric medications are safe, effective, and can be lifesaving if they are taken properly — as directed — under the care of an appropriately licensed healthcare professional,” the statement read. “These medications can significantly improve the quality of life for children struggling with mental health conditions, including those at imminent risk of suicide, by helping to alleviate symptoms of depression, mania, anxiety, obsessive-compulsive disorder, Tourette’s disorder, ADHD, and psychotic illness.

“We urge the Federal government and our colleagues within the scientific and practitioner communities not to disregard the critical role played by the appropriate use of evidence-based psychotropic medications in the treatment of individuals with psychiatric conditions that carry inherent high risks for suicide or other dangerous or life-threatening behaviors.”

The signatories included:

  • American Society of Clinical Psychopharmacology (ASCP)
  • American College of Neuropsychopharmacology (ACNP)
  • American Association of Chairs of Departments of Psychiatry (AACDP)
  • American Psychiatric Association (APA)
  • National Network of Depression Centers (NNDC)
  • Society of Biological Psychiatry (SOBP)

HSS did not respond to a request for comment.

Further Reading

Psychotropic Medication Prescriptions for Home-Based Palliative Care Oncology Patients

Correlating Psychotropic Use to Major Depressive Disorder and ADHD Research Diagnoses

SSRI Behavioral Activation, the Boxed Bolded Warning, and Neurodevelopmental Disorders