Off Label Medications and Mental Health

Video Description

Main Chapters: 00:00 Intro – Off Label Medications 00:11 Take home message 01:24 Ketamine and Off Label Use 08:38 Medication Regulation in the USA 14:24 Examples of Off Label Use 20:40 Risk Evaluation and Mitigation Strategy (REMS) 23:54 DEA Medication Schedules (Drug Enforcement Administration) 27:41 Medication Restriction Approaches 29:49 Conclusion The FDA has a mandate to ensure that prescription medications are safe and effective. But it makes little sense that one form of ketamine, Spravato, approved for depression, can only be used in a doctor's office, in a very restricted range of dosages, whereas other clinics can use ketamine to treat pain, depression, PTSD, ADHD and other conditions, at massively higher doses and frequencies, including potentially brain damaging amounts, because those uses are "off-label". Learn more about what off-label use entails, how prevalent it is, and about the risk evaluation and mitigation strategies (REMS) programs that the FDA had required for 71 medications, which put stringent restrictions on their accessibility and use. ----- Free link to my Medium Article on Off Label Medications: https://medium.com/wise-well/somethings-off-with-off-label-prescribing-3253f72b8e92?sk=14cddae93941a32b2fa278c8f6c96a38 Follow https://dockruse.medium.com on Medium for hundreds of full length articles on this subject and more! Access to Full Medium articles requires paid membership. ----- Videos mentioned: Ketamine for ADHD: https://youtu.be/wM5JklE2kIQ Amlodipine for ADHD: https://youtu.be/RXhC7NwdiTY Amantadine for ADHD: https://youtu.be/VtYhST2hhnE References: Ketamine for Depression, but at What Cost? A Review of Ketamine’s Neurotoxic Effects From Preclinical and Human Studies (2025) https://www.psychiatryonline.org/doi/abs/10.1176/appi.ajp.20250276?af=REsketamine Treatment for Depression in Adults: A PRISMA Systematic Review and Meta-Analysis (2025) https://psychiatryonline.org/doi/10.1176/appi.ajp.20240515 Real-World Safety of Esketamine Nasal Spray: A Comprehensive Analysis Almost 5 Years After First Approval (2025) https://www.psychiatryonline.org/doi/10.1176/appi.ajp.20240655 Off-label policy through the lens of trazodone usage and spending in the United States (2025) https://pmc.ncbi.nlm.nih.gov/articles/PMC12278056/ Effectiveness of Risk Evaluation and Mitigation Strategies (REMS) for Lenalidomide and Thalidomide: Patient Comprehension and Knowledge Retention (2017) https://pmc.ncbi.nlm.nih.gov/articles/PMC5362654/ FDA policies on Risk Evaluation and Mitigation Strategies (REMS) https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems Full Chapter list: 00:00 Intro – Off Label Medications 00:11 Take home message 01:24 Ketamine and Off Label Use 03:01 Esketamine (Spravato) 06:29 Ketamine Clinics 07:04 Potential Side Effects of Ketamine 08:38 Medication Regulation in the USA 10:05 FDA Approval Process (Food and Drug Administration) 12:34 Medications and Indications 14:24 Examples of Off Label Use 16:01 Trazodone / Amlodipine / Amantadine 17:27 Thalidomide 20:40 Risk Evaluation and Mitigation Strategy (REMS) 22:10 Accutane (Isotretinoin) / Clozaril (Clozapine) 23:54 DEA Medication Schedules (Drug Enforcement Administration) 25:29 Ketamine / Alcohol and DEA Scheduling 27:41 Medication Restriction Approaches 28:58 Monitoring Off Label Use 29:49 Conclusion ------------------------- Psychiatrist, neuroscientist, and author John Kruse, MD, PhD presents practical, actionable, well-researched information about treatment options that scientists and clinicians recommend for adult ADHD and other mental health conditions. Subscribe if you're curious about how neuroatypical brains can optimize their functioning in our shared, and somewhat strange, world. ADHD topics have a pink background, and those on more general mental health topics have a purple background. A small collection of Politics related videos have an orange background. Dr. Kruse has posted videos in the "Videos", "Live", and "Shorts", sections of this channel. You're welcome to email him with topics you want discussed or people you think he should interview. [email protected] #health #mentalhealth #offlabel #medication